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52. Two weeks of low molecular weight heparin for isolated symptomatic distal vein thrombosis (twister study): Interim analysis of first 100 patients-post thrombotic syndrome sub-study.

Author

Chunilal S., Tran H., Brighton T., Merriman E., McRae S., Chunilal S., Tran H., Brighton T., Merriman E., and McRae S.

Abstract

Background: Most deep vein thrombi (DVT) originate from a small calf vein (distal vein) thrombus, however 80-90% of distal DVT lyse spontaneously and are probably of minimal clinical consequence. The treatment and management of isolated distal DVT (IDDVT) thrombi is controversial, with treatments ranging from withholding of anticoagulation and a repeat compression vein ultrasound (CUS) of the leg veins in a week, to 3 months of full dose anticoagulation. Aim(s): The TWISTER Study is a multicentre Australasian study examining the safety of 2 weeks of anticoagulation for a first episode of symptomatic IDDVT. The primary outcome is symptomatic recurrence of venous thrombosis DVT and pulmonary embolism, PE) within 3 months. Method(s): Patients with confirmed symptomatic distal DVT received 2 weeks of therapeutic anticoagulation (enoxaparin or rivaroxaban) and had a repeat CUS at the end of 2 weeks. If the patient was asymptomatic and there was no proximal DVT extension on CUS, treatment was stopped. If the patient was still symptomatic then treatment was continued for a further 4 weeks. Result(s): An interim analysis of the first 100 patients was performed. Ninety-three received enoxaparin; 7 received rivaroxaban. The duration of anticoagulation was 2 weeks (+/- 1 week) for 77 patients, 6 weeks for 21 patients (with 2 receiving an additional 6 weeks at the investigator's discretion), and 3 months for 2 patients due to asymptomatic proximal extension on the 2 week CUS. There were also 5 extensions within the distal venous system, with all occurring whilst on full dose anticoagulation. There has been one VTE recurrence within 3 months (1.3%; 95%CI 0-3.8%), a distal DVT in the contralateral leg. All events were reviewed by three blinded adjudicators. Conclusion(s): Our preliminary data suggest 2 weeks of therapeutic anticoagulation is sufficient for the majority of patients (77%) with a first episode of symptomatic IDDVT, with a low rate of VTE recurrence within 3 months (

Published
2015

53. A multi-centre, single-arm, open-label study evaluating the safety and efficacy of fixed dose rituximab in patients with refractory, relapsed or chronic idiopathic thrombocytopenic purpura (R-ITP1000 study).

Author

Truman M., Marlton P., Catalano J., Tran H., Brighton T., Grigg A., Mcrae S., Dixon J., Thurley D., Gandhi M.K., Truman M., Marlton P., Catalano J., Tran H., Brighton T., Grigg A., Mcrae S., Dixon J., Thurley D., and Gandhi M.K.

Abstract

The efficacy of a fixed-dose rituximab schedule was prospectively explored in primary/acute refractory, relapsed or chronic (platelet count >10 x 109/l and <=50 x 109/l) idiopathic thrombocytopenic purpura (ITP). Patients received two doses of rituximab (1000 mg) on days 1 and 15 and were followed-up on weeks 1-8, 12, 26, 39 and 52. A total of 122 patients were included in the safety population; efficacy was analysed in 108 patients. Overall response rate (ORR) at week 8, defined as the proportion of patients achieving complete response (CR; platelet count >150 x 109/l) or partial response (PR; platelet count >50 x 109/l) was 44%. Therapeutic response, defined as achieving a response at week 8, with at least a minor response (MR; platelet count >30 x 109/l), sustained up to weeks 26 and 52 and accompanied by a reduction in ITP medications, was achieved in 44% (week 26) and 35% (week 52) of patients, respectively. Treatment was well tolerated with no safety concerns. While this study failed to meet its primary endpoint of an ORR of 50%, the efficacy of two fixed doses of rituximab appear to provide similar efficacy to the standard 375 mg/m2 four-dose schedule in relapsed/chronic ITP.Copyright © 2014 John Wiley & Sons Ltd.

Published
2015

54. Safety and efficacy of fixed dose rituximab in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura, r-ITP1000 study-final analysis.

Author

Gandhi M., Catalano J., Tran H., Brighton T., Grigg A., McRae S., Dixon J., Thurley D., Gandhi M., Catalano J., Tran H., Brighton T., Grigg A., McRae S., Dixon J., and Thurley D.

Abstract

Background. Idiopathic thrombocytopenic purpura (ITP) is an auto-immune disorder characterized by low platelet count and mucocutaneous bleeding. Post-acute presentation, 25-30% adult patients develop chronic ITP, up to 30% of whom become refractory to corticosteroids and require additional therapy. B-cells play an important pathophysiological role in auto-immune disease. Rituximab depletes CD20+ B-cells and an exploratory dosing regimen based on lymphoma therapy (375 mg/m2 weekly intravenous x4) has shown promising efficacy (~38% overall response rate-ORR) in adults with chronic and relapsing ITP. We explored the effectiveness of an abbreviated fixed dose rituximab schedule that has been approved in rheumatoid arthritis. Rituximab is not currently approved for the treatment of ITP. Aims. The primary objective was to determine the ORR at week 8 in adults (>=18 years), with chronic or relapsing ITP (platelet count >10x109/L and <=50x109/L) according to the ASH guidelines, who received rituximab 1000mg on days 1 and 15. Secondary objectives included time to, duration of and incidence of therapeutic response (defined below). Methods. After obtaining informed consent, patients received scheduled rituximab and were followed-up for at least 12 weeks. Evaluations were at mandatory follow-up visits on weeks 8, 12, 26, 39 and 52. ORR was defined as the proportion of patients achieving complete response (CR, platelet count >150x109/L) or partial response (PR, >50x109/L) at week 8 with 2 consecutive measurements, confirmed at least 2 weeks apart. Minor response (MR) was defined as platelet count >30x109/L. Simon's 2-stage design was used to determine if the ORR was more likely to be <=38% or >=50%. At least 50 out of 108 responders (46%) were required to conclude, with 95% confidence and 80% power, that the ORR was more likely to be >=50%. Duration of response was determined for patients with a response (MR/PR/CR) at week 8. Time to response was defined as time from first ritux

Published
2015

55. Two weeks of low molecular weight heparin for isolated symptomatic distal vein thrombosis (twister study): Interim analysis of first 100 patients.

Author

Merriman E., Tran H., Chunilal S., McRae S., Brighton T., Merriman E., Tran H., Chunilal S., McRae S., and Brighton T.

Abstract

Background: Most deep vein thrombi (DVT) originate from a small calf vein (distal vein) thrombus, however 80-90% of distal DVT lyse spontaneously and are probably of minimal clinical consequence. The treatment and management of isolated distal DVT (IDDVT) thrombi is controversial, with treatments ranging from withholding of anticoagulation and a repeat compression vein ultrasound (CUS) of the leg veins in a week, to three months of full dose anticoagulation. Aim(s): The TWISTER Study is a multicentre Australasian study examining the safety of two weeks of anticoagulation for a first episode of symptomatic IDDVT. The primary outcome is symptomatic recurrence of venous thrombosis DVT and pulmonary embolism, PE) within 3 months. Method(s): Patients with confirmed symptomatic distal DVT received 2 weeks of therapeutic anticoagulation (enoxaparin or rivaroxaban) and had a repeat CUS at the end of 2 weeks. If the patient was asymptomatic and there was no proximal DVT extension on CUS, treatment was stopped. If the patient was still symptomatic then treatment was continued for a further four weeks. All study events were centrally adjudicated (blinded). Result(s): An interim analysis of the first 100 patients was performed. Ninety-three received enoxaparin; 7 received rivaroxaban. The duration of anticoagulation was 2 weeks (+/-1 week) for 77 patients, 6 weeks for 21 patients (with 2 receiving an additional 6 weeks at the investigator's discretion), and 3 months for 2 patients due to asymptomatic proximal extension on the 2 week CUS. There were also 7 extensions within the distal venous system, with all occurring whilst on full dose anticoagulation. There has been one VTE recurrence within 3 months (1.3%; 95%CI 0-3.8%), a distal DVT in the contralateral leg. Conclusion(s): Our preliminary data suggest two weeks of therapeutic anticoagulation is sufficient for the majority of patients (77%) with a first episode of symptomatic IDDVT, with a low rate of VTE recurrence within 3

Published
2015

56. Factor VIII gene (F8) mutation and inhibitor development in non-severe hemophilia A

Author

De Groot-Eckhardt, C. L., Van Velzen, A. S., Peters, Marloes, Peerlinck, K., Oldenburg, J., Santagostino, E., Astermark, J., Van Heerde, W. L., Hermans, C., Morfini, M., Castaman, G., Haya, S., McRae, S., Reitter-Pfoertner, S. E., Kamphuisen, P. W., Van der Bom, J. G., Fijnvandraat, K. J., Cardiovascular Centre (CVC), and Vascular Ageing Programme (VAP)

Subjects
genotype, Australia, neutralizing antibody, population, high risk patient, blood clotting factor 8 concentrate, bleeding, Europe, society, confidence interval, blood clotting factor 8, exposure, hemophilia, hemostasis, hemophilia A, gene mutation, human, patient, mutation, point mutation, thrombosis, risk
Abstract

Background: The development of neutralizing antibodies (inhibitors) towards factor VIII is a major complication in non-severe hemophilia A, profoundly aggravating the bleeding pattern. Identification of high risk patients is hampered by lack of data on the association between factor VIII gene (F8) mutations and the development of inhibitors that take exposure days to therapeutic factor VIII concentrates into account. Aims: To determine the risk of inhibitor development in patients with non-severe hemophilia A and to analyze the association with F8 mutation, taking exposure days to therapeutic factor VIII concentrates into account. Methods: The study population was derived from a source population of 2711 non-severe hemophilia A patients (factor VIII 2-40%), treated in 34 hemophilia treatment centers in Europe and Australia (the INSIGHT consortium). The association between F8 mutation and inhibitor development was assessed in 1112 patients, only recruited from centers that had genotyped at least 70% of their patients. Inhibitor risk was calculated as Kaplan-Meier incidence with cumulative number of exposure days as time variable. Thus, risk was calculated as the proportion of patients that developed an inhibitor after a certain number of exposure days (e.g. 20 or 50) to therapeutic factor VIII concentrates. Results: During 44,800 exposure days (median 24 exposure days per patient; Inter Quartile Range (IQR), 7-90), 59 of the 1112 patients developed an inhibitor; cumulative incidence of 5.3% (95% confidence interval (CI), 4.0-6.6) after a median of 28 exposure days (IQR, 12- 71). The inhibitor risk at 50 exposure days was 6.7% (95% CI, 4.5- 8.9) and at 100 exposure days this risk was further increased to 13.3% (95% CI, 9.6-17.0). Among a total of 221 different F8 point mutations 19 were associated with inhibitor development. The inhibitor risk was highest for R593C, D2074G, R2159C and W2229C, reaching 19%, 21%, 39% and 42%, respectively, at 50 exposure days. Conclusion: Among a total of 221 different point mutations, 19 mutations were associated with inhibitor development. Longitudinal analysis revealed that the inhibitor incidence in non-severe hemophilia A patients with certain F8 mutations approaches the incidence observed in patients with severe hemophilia. These results emphasize the importance of F8 genotyping in non-severe hemophilia A. New preventive and therapeutic approaches in this patient group are urgently needed.

Published
2013

57. Oral Apixaban for the Treatment of Acute Venous Thromboembolism

Author

Agnelli, G, Buller, H, Cohen, A, Gallus, A, Raskob, G, Weitz, J, Prins, M, Brandjes, D, Kolbach, D, Limburg, M, Mac Gillavry, M, Otten, Jm, Peters, R, Roos, Y, Segers, A, Slagboom, T, Bounameaux, H, Hirsh, J, Samama, Mm, Wedel, H, Curto, M, Johnson, M, Masiukiewicz, U, Pak, R, Porcari, A, Sanders, P, Sisson, M, Sullivan, B, Thompson, J, Auerbach, J, Cesario, L, Crawford, J, Gordon, M, Noble, M, Pennington, A, Reinhold, P, Simmons, M, Urwin, K, Ceresetto, J, Mcrae, S, Pabinger, I, Pereira, Ah, Spencer, F, Wang, C, Zhang, J, Gorican, K, Husted, Se, Mottier, D, Harenberg, J, Vértes, A, Pinjala, R, Zeltser, D, Prandoni, Paolo, Sandset, M, Torbicki, A, Fijalkowska, A, Alvares, Jp, Kirienko, A, Shvarts, Y, Sala, La, Jacobson, B, Gudz, I, Ortel, T, Spyropoulos, A, Beyer Westendorf, J, Sipos, G, Bredikhin, R, Della Siega, A, Klinke, W, Lawall, H, Zwettler, U, Prasol, V, Cannon, K, Vasylyuk, S, Jin, B, Prandoni, P, Desai, S, Zaichuk, A, Katelnitskiy, I, De Pellegrin, A, Santonastaso, M, Skupyy, O, Pesant, Y, Shvalb, P, Spacek, R, Visonà, A, Alvarez Sala, L, Borja, V, Noori, E, Sereg, M, Braester, A, Falvo, N, Vöhringer, H, Laperna, L, Oliven, A, Skalicka, L, Bolster, D, Haidar, A, Schellong, S, Smith, S, Sergeev, O, Pullman, J, Torp Pedersen, C, Zimlichman, R, Elias, M, Fourie, N, Pernod, G, Panchenko, E, Pendleton, R, van Nieuwenhuizen, E, Vinereanu, D, Becattini, C, Manina, G, Leduc, J, Dunaj, M, Frost, L, Gavish, D, Jakobsen, T, Lishner, M, Morales, L, Chochola, J, Gubka, O, Holaj, R, Hussein, O, Katona, A, Sergeeva, E, Bova, C, Cepeda, J, Cohen, K, Sobkowicz, B, Grzelakowski, P, Husted, S, Lupkovics, G, Dedek, V, Liu, C, Puskas, A, Ritchie, B, Ambrosio, G, Parisi, R, Heuer, H, Livneh, A, Podpera, I, Stanbro, M, Caraco, Y, Fulmer, J, Ghirarduzzi, A, Schmidt Lucke, J, Bergmann, J, Cizek, V, Leyden, M, Stein, R, Abramov, I, Chong, B, Colan, D, Jindal, R, Liu, S, Pereira, A, Porreca, E, Salem, H, Welker, J, Yusen, R, Dhar, A, Podczeck Schweighofer, A, Shtutin, O, Vital Durand, D, Balaji, V, Correa, J, Kline, J, Runyon, M, Laszlo, Z, Martelet, M, Parakh, R, Sandset, Pm, Schmidt, J, Yeo, E, Bhagavan, N, Bura Riviere, A, Ferrer, J, Lacroix, P, Lewczuk, J, Pilger, E, Sokurenko, G, Yu, H, Nikulnikov, P, Pabinger Fasching, I, Sanchez Diaz, C, Schuller, D, Suresh, K, Lobo, S, Lyons, R, Marschang, P, Palla, A, Schulman, S, Spyropoulous, A, Fraiz, J, Gerasymov, V, Lerner, R, Llamas Esperón, G, Manenti, E, Masson, J, Moreira, R, Poy, C, Rodoman, G, Bruckner, I, Gurghean, A, Carrier, M, Freire, A, Gan, E, Gibson, K, Herold, M, Hudcovic, M, Kamath, G, Koslow, A, Meneveau, N, Roos, J, Zahn, R, Balanda, J, Bratsch, H, Dolan, S, Gould, T, Hirschl, M, Hoffmann, U, Kaatz, S, Shah, V, Kadapatti, K, Kræmmer Nielsen, H, Lahav, M, Natarajan, S, Tuxen, C, Tveit, A, Alves, C, Formiga, A, Brudevold, R, Cardozo, M, Lorch, D, Marais, H, Mismetti, P, Panico, M, Pop, C, Quist Paulsen, P, Stevens, D, Tarleton, G, Yoshida, W, Cox, M, Crispin, P, Czekalski, P, Ebrahim, I, Game, M, Ghanima, W, Harrington, D, Jackson, D, Lee, A, Matoska, P, Meade, A, Camargo, Ac, Nishinari, K, Sanchez Llamas, F, Tosetto, A, Vejby Christensen, H, Basson, M, Blombery, P, Fu, G, Jha, V, Keltai, K, Le Jeunne, C, Lodigiani, C, Ma, Y, Nagy, A, Neumeister, A, Shotan, A, Wong, T, Ying, K, Anderson, S, Brenner, B, Carnovali, M, Cerana, S, Cunha, C, Diaz Castañon, J, Graham, M, Kirenko, A, Palareti, G, Rodriguez Cintron, W, Nathanson, A, Rosenthal, S, Sanders, D, Scheinberg, P, Schjesvold, F, Torp, R, van Zyl, L, Venher, I, Xia, G, Brockmyre, A, Chen, Z, Hakki, S, Hanefield, C, Mügge, A, Janczak, D, Karpovych, D, Lancaster, G, Lavigne, C, Lugassy, G, Melaniuk, M, Moran, J, Oliver, M, Schattner, A, Staroverov, I, Timi, J, Vöhringer, F, von Bilderling, P, Warr, T, White, R, Wronski, J, Wu, C, Almeida, C, Blum, A, Bono, J, Durán, M, Erzinger, F, Fu, W, Jagadesan, R, Jurecka, W, Korban, E, Nguyen, D, Raval, M, Willms, D, Zevin, S, Zhu, H, Abdullah, I, Achkar, A, Albuquerque, L, Ali, M, Bai, C, Bloomfield, D, Chen, J, Fajardo Campos, P, Garcia Bragado, F, Kobza, I, Lindhoff Last, E, Lourenço, A, Marchena Yglesias, P, Marshall, P, Siegel, M, Mikhailova, O, Oliva, M, Pottier, P, Pruszczyk, P, Sauer, M, Baloira, A, Cromer, M, D'Angelo, A, Faucher, J, Gutowski, P, Hong, S, Lissauer, M, Lopes, A, Lopes, R, Maholtz, M, Mesquita, E, Miekus, P, Mohan, B, Ng, H, Peterson, M, Piovella, F, Siragusa, S, Srinivas, R, Tiberio, G, Van Bellen, B, Arutyunov, G, Assi, N, Baker, R, Blanc, F, Curnow, J, Fu, C, Gonzalez Porras, J, Guijarro Merino, R, Gunasingam, S, Gupta, P, Laule, M, Liu, Z, Luber, J, Serifilippi, G, Paulson, R, Shevela, A, Simonneau, G, Siu, D, Sosa Liprandi, M, Takács, J, Tay, J, Vora, K, Witkiewicz, W, Zhao, L, Aquilanti, S, Dabbagh, O, Dellas, C, Denaro, C, Doshi, A, Flippo, G, Giumelli, C, Gomez Cerezo, J, Han, D, Harris, L, Hofmann L., Jr, Kamerkar, D, Kaminski, L, Kazimir, M, Kloczko, J, Ko, Y, Koura, F, Lavender, R, Maly, J, Margolis, B, Mos, L, Sanchez Escalante, L, Solvang, A, Soroka, V, Szopinski, P, Thawani, H, Vickars, L, Yip, G, Zangroniz, P., Internal and Cardiovascular Medicine - Stroke Unit (PERUGIA - ICM-SU), Università degli Studi di Perugia (UNIPG), Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), King's College Hospital (KCH), Department of Haematology (ADELAIDE - Dep Haemato), Flinders Medical Centre-Flinders University, Health Sciences Center (OKLAHOMA - HSC), University of Oklahoma (OU), Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, APH - Amsterdam Public Health, Cardiology, ANS - Amsterdam Neuroscience, Neurology, and Other departments

Subjects
Male, MESH: Factor Xa, [SDV]Life Sciences [q-bio], Administration, Oral, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, THERAPY, MESH: Venous Thromboembolism, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Warfarin, MESH: Treatment Outcome, MESH: Aged, RISK, MESH: Middle Aged, General Medicine, MESH: Follow-Up Studies, Venous Thromboembolism, Middle Aged, 3. Good health, Pulmonary embolism, Treatment Outcome, MESH: Administration, Oral, Acute Disease, MESH: Acute Disease, Apixaban, Female, MESH: Hemorrhage, medicine.drug, Andexanet alfa, Adult, medicine.medical_specialty, MESH: Enoxaparin, Pyridones, PULMONARY-EMBOLISM, Hemorrhage, MESH: Anticoagulants, 03 medical and health sciences, Double-Blind Method, BINOMIAL TRIALS, Internal medicine, MESH: Pyridones, medicine, Humans, Enoxaparin, MESH: Kaplan-Meier Estimate, RIVAROXABAN, Aged, Rivaroxaban, MESH: Humans, business.industry, Warfarin, Anticoagulants, MESH: Adult, medicine.disease, Confidence interval, MESH: Male, Surgery, chemistry, Relative risk, Pyrazoles, business, MESH: Female, MESH: Pyrazoles, Factor Xa Inhibitors, Follow-Up Studies
Abstract

International audience; BACKGROUND: Apixaban, an oral factor Xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism. METHODS: In this randomized, double-blind study, we compared apixaban (at a dose of 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months) with conventional therapy (subcutaneous enoxaparin, followed by warfarin) in 5395 patients with acute venous thromboembolism. The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism. The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding. RESULTS: The primary efficacy outcome occurred in 59 of 2609 patients (2.3%) in the apixaban group, as compared with 71 of 2635 (2.7%) in the conventional-therapy group (relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18; difference in risk [apixaban minus conventional therapy], -0.4 percentage points; 95% CI, -1.3 to 0.4). Apixaban was noninferior to conventional therapy (P

Published
2013
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58. Australian multicentre study of current real‐world prophylaxis practice in severe and moderate haemophilia A and B.

Author

Parikh, S., Mason, J. A., Rowell, J., McRae, S., and Tran, H.

Subjects
PREVENTIVE medicine, HEMOPHILIA, PHARMACOKINETICS, PATIENT compliance, PATIENTS
Abstract

Introduction: With the emergence of novel treatment products for haemophilia and an increasing focus on the benefits of pharmacokinetic driven individualized prophylaxis, robust national data with regard to current patterns of factor consumption and adherence are required. Aim: To characterize current Australian practice with regard to use of prophylactic clotting factor infusions in patients with moderate or severe haemophilia A (HA) and haemophilia B (HB). Methods: This was a retrospective, non‐interventional study utilizing Australian Bleeding Disorder Registry (ABDR) data collected over a 12 month period. Registered and consented patients with moderate or severe HA or HB without inhibitors were included. Results: A total of 718 HA (551 severe, 167 moderate) and 166 HB (87 severe, 79 moderate) patients were included. Regular prophylaxis was prescribed in 453 patients (82%) with severe HA, 42 patients (25%) with moderate HA, 66 patients (75%) with severe HB and 11 patients (14%) with moderate HB. Near universal prophylaxis was achieved in the paediatric subgroup. The mean weekly dose of factor VIII in severe HA was 84 international units/kg/wk (IU/kg/wk) vs 71 IU/kg/wk of factor IX in severe HB. Most patients on prophylaxis were treated ≥3 times/wk (HA) or 2 times/wk (HB). Non‐adherence peaked in the 20‐29 year age group. Older individuals on regular prophylaxis used more factor than was expected for their prescribed regimen. Conclusion: Prophylaxis rates in severe haemophilia are comparable with other developed nations. The benefit of a national registry is demonstrable. Furthermore research into the underlying reasons for non‐compliance in young adults with haemophilia is required. [ABSTRACT FROM AUTHOR]

Published
2018
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59. Apixaban for extended treatment of venous thromboembolism

Author

Agnelli, G, Buller, H, Cohen, A, Gallus, A, Raskob, G, Weitz, J, Prins, M, Brandjes, D, Kolbach, D, Limburg, M, Mac Gillavry, M, Otten, Jm, Peters, R, Roos, Y, Segers, A, Slagboom, T, Bounameaux, H, Hirsh, J, Samama, Mm, Wedel, H, Curto, M, Johnson, M, Masiukiewicz, U, Pak, R, Porcari, A, Sanders, P, Sisson, M, Sullivan, B, Thompson, J, Auerbach, J, Cesario, L, Gamero, M, Gordon, M, Griffiths, A, Noble, M, Ott, J, Pennington, A, Peffer, A, Reinhold, P, Simmons, M, Urwin, K, Ceresetto, J, Mcrae, S, Pabinger, I, Pereira, Ah, Spencer, F, Gorican, K, Husted, Se, Mottier, D, Harenberg, J, Pinjala, R, Zeltser, D, Imberti, D, Sandset, M, Torbicki, A, Fijalkowska, A, Albino, Jp, Kirienko, A, Shvarts, Y, Monreal, M, Jacobson, B, Dolan, G, Gudz, I, Ortel, T, Spyropoulos, A, Skupyy, O, Beryer Westendorf, J, De Pellegrin, A, Prasol, V, Schellong, S, Falvo, N, Abramov, I, Cizek, V, Husted, S, Desai, S, Barillari, G, Sergeev, O, Chetter, I, Inbal, A, Mccollum, C, Shvalb, P, Torp Pedersen, C, Vasylyuk, S, Kraemmer Nielsen, H, Pernod, G, Schmidt, J, Bova, C, Gerasymov, V, Pabinger Fasching, I, Skalicka, L, Zaichuk, A, Achkar, A, Bremmelgaard, A, Chochola, J, Gould, T, Khalafallah, A, Jakobsen, T, Rose, P, Zhukov, B, Dedek, V, Mirete Ferrer, J, Pesant, Y, Repin, A, Salem, H, Solis Morales, L, Spacek, R, Cannon, K, Grzelakowski, P, Jindal, R, Pereira, A, Zidkova, E, Ambrosio, G, Cardozo, M, Dunaj, M, Gavish, D, Ghanima, W, Leduc, Jj, Mismetti, P, Panico, M, Porreca, E, Riera, A, Bareford, D, Chong, B, Dvoryashina, I, Gómez Cerezo, J, Kobza, I, Nielsen, T, Pendleton, R, Pullman, J, Schiffman, G, Stanbro, M, Zwettler, U, Aquilanti, S, Bratsch, H, Cohen, K, Elias, D, Gan, E, Holaj, R, Klinke, W, Liu, Hs, Sandset, Pm, van Nieuwenhuizen, E, Álvarez Sala LA, Basson, M, Braester, A, Bura Riviere, A, Calvo Vargas, C, Correa, J, Elias, M, Frost, L, Landolfi, R, Marschang, P, Moreira, R, Natarajan, S, Pottier, P, Tosetto, A, Tuxen, C, Vöhringer, Hf, Alexander, A, Barbarash, O, Fajardo Campos, P, Graham, M, Gubka, O, Hudcovic, M, Hussein, O, Jackson, D, Katelnitskiy, I, Lawall, H, Palareti, G, Poggio, R, Roos, J, Simonneau, G, Smith, Sw, Szopinski, P, Zimlichman, R, Bridgers, D, Colan, D, Czekalski, P, De Jong, D, Fortinez, Jt, Garcia Bragado, F, Harrington, D, Izbicki, G, Kadr, H, Koslow, A, Loftus, I, Marais, H, Neumeister, A, Oliven, A, Palla, A, Pop, C, Prandoni, Paolo, Puskas, A, Sanchez Llamas, F, Shotan, A, Singh, P, Tveit, A, Baker, R, Borja, V, Brenner, B, Brown, H, Cha, Tj, Cohen, Y, D'Angelo, A, Dhar, A, Friis, E, Hueur, H, Jiménez Rodríguez Madridejos, R, Karl, J, Karrasch, J, Lishner, M, Manenti, E, Meneveau, N, Nguyen, D, Sanchez Escalante, L, Santoscoy Ibarra, J, Sokurenko, G, Staroverov, I, Stein, R, Abdullah, I, Alcocer Gamba, M, Balanda, J, Bruckner, I, Calabuig Alborch, J, Caraco, Y, Comerota, A, Cromer, M, de Araujo Filho, J, De los Rios Ibarra, M, Diaz Castañon, J, Doshi, A, Ebrahim, I, Fessel, Wj, Fletcher, E, Fourie, N, Fu, C, Gutowski, P, Haddad, G, Hoffman, U, Jardula, M, Kvasnicka, T, Lewczuk, J, Leyden, M, Livneh, A, Lodigiani, C, Lovell, C, Miekus, P, Paloma, Mj, Parakh, R, Raval, M, Schmidt Lucke, J, Shtutin, O, Soroka, V, Stevens, D, Sulik, P, Tay, Jc, Vejby Christensen, H, Vinereanu, D, Baghestanian, M, Bono, J, Cerana, S, Freire, A, Gibson, K, Giumelli, C, Iastrebner, C, Karpenko, A, Kelly, A, Lacroix, P, Lafata, J, Lobo, S, Macik, Bg, Marchena Yglesias, P, Nishinari, K, Podczeck Schweighofer, A, Raby, K, Sirpal, S, Solymoss, S, van Zyl, L, Vargas Núñez JA, von Bilderling, P, Warr, T, Wronski, J, Wurster, M, Albino, Ja, Albuquerque, L, Averill, F, Baek, Sh, Bello, F, Bergoeing, M, Blanc, Fx, Bloomberg, R, Bolster, D, Brockmyre, A, Calimano, C, Checketts, D, Cieplinski, W, Chervu, A, Collado, F, Denaro, C, Gaciong, Z, Game, M, Iskander, A, Kaatz, S, Kim, Di, Koura, F, Laguna, F, Lanas Zanetti, F, Lindhoff Last, E, Melaniuk, M, Meade, A, Murphy, T, Ng, Hj, Páramo Fernández JA, Patil, C, Piovella, F, Prisco, D, Pruszczyk, P, Reimers, G, Rivera, E, Rodriguez Cintron, W, Rosenthal, S, Salbach, P, Salvador, D, Schuller, D, Siragusa, S, Staniszewski, R, Torp, R, Vora, K, Yip, G, Alfieri, A, Belaji, V, Bhagavan, N, Carnovali, M, Cobos Segarra, J, Di Todaro, F, Dowell, A, Corder, C, Crispin, P, Cuadrado, J, Flippo, G, Fraiz, J, Guillaumon, A, Gvora, T, Hakki, S, Harris, L, Ison, R, Htun, Pt, Jasani, R, Kates, M, Kaminski, L, Kamerkar, D, Kroger, K, Laperna, L, Leiva, J, Luber, J, Mccann, A, Mckenzie, W, Menna Barreto, S, Moran, J, Nikulnikov, P, Paliwal, Y, Patel, M, Pilger, E, Renwick, W, Shevela, A, Starosiliz, D, Stringam, S, To, R, Updegrove, J, Van Bellen, B, Waintrub, M, White, J, Yeo, E, Zangroniz, P, Zeltser, D., ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, APH - Amsterdam Public Health, Cardiology, ANS - Amsterdam Neuroscience, Neurology, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)

Subjects
Male, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Placebo group, DISEASE, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Recurrence, Fibrinolytic agents, 030212 general & internal medicine, IDRAPARINUX, Administration of drugs, Follow up studies, food and beverages, General Medicine, Venous Thromboembolism, Middle Aged, 3. Good health, Intention to Treat Analysis, Treatment Outcome, Treatment dose, Anesthesia, Creatinine, Factor Xa, Fibrinolítics, Apixaban, Female, Administració de medicaments, Major bleeding, medicine.drug, ARTERIAL CARDIOVASCULAR EVENTS, INTENSITY WARFARIN THERAPY, PULMONARY-EMBOLISM, LONG-TERM, PREVENTION, Adult, Pyridones, Hemorrhage, 03 medical and health sciences, Double-Blind Method, Fibrinolytic Agents, Thromboembolism, medicine, Humans, Tromboembolisme, Aged, Intention-to-treat analysis, business.industry, fungi, Pyrazoles, business, Venous thromboembolism, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Factor Xa Inhibitors, Follow-Up Studies
Abstract

International audience; Background Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose regimen, may be an option for the extended treatment of venous thromboembolism. Methods In this randomized, double-blind study, we compared two doses of apixaban (2.5 mg and 5 mg, twice daily) with placebo in patients with venous thromboembolism who had completed 6 to 12 months of anticoagulation therapy and for whom there was clinical equipoise regarding the continuation or cessation of anticoagulation therapy. The study drugs were administered for 12 months. Results A total of 2486 patients underwent randomization, of whom 2482 were included in the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%) who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving 5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1) (P

Published
2012
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60. Enoxaparin followed by once-weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double-blind, double-dummy, non-inferiority trial

Author

Büller, Hr, Gallus, As, Prins, Mh, Raskob, G, Decousus, H, Charbonnier, B, Leizorovicz, A, Laporte, S, Quenet, S, Brandjes, Dp, Middeldorp, S, Blüguermann, J, Amuchastegui, L, Ahuad Guerrero, R, Oberti, P, Alvarez, C, Cassettari, A, Santos, D, Macin, S, Santini, F, Ward, C, Coughlin, P, Salem, H, Gan, E, Leyden, M, Prosser, I, Crispin, P, Carroll, P, Gallus, A, Mcrae, S, Waites, J, Pilger, E, Koppensteiner, R, Kyrle, P, Schinko, H, Mrochek, A, Mitkovskaya, N, Prystrom, A, Motte, S, Ninane, V, Delcroix, M, Hainaut, P, Schneider, E, Saraiva, J, Maia, L, Barreto, S, Fernandes Manenti, E, Araujo, G, Dutra, O, Fiss, E, Moreira, R, Yankov, K, Nenkova, S, Ivanov, Y, Kostov, V, Bhargava, R, Chan, Y, Miron, Mj, Cusson, J, Ugarte, S, Morales, A, Andresen, M, Lanas, F, Arriagada, G, Mendoza, Jj, Zuñiga, C, Sepulveda, P, Wang, C, Liu, Z, Yuan, Y, Ma, Z, Fang, B, Liu, J, Bai, C, Wu, H, Yang, L, Ying, K, Kang, J, Li, Q, Cheng, Z, Zhang, J, Wang, H, Xie, C, Xia, G, Du, Y, Wu, Q, Zhou, X, Chen, L, Yi, Q, Wu, C, Hao, Q, Liu, S, Xiong, S, Jiang, S, Zhao, L, Xiao, Q, Qin, Z, Zhou, J, Dennis, R, Miserque, N, Igueredo, M, Londoño, D, Hildebrando, J, Granados, M, Buitrago, R, Solano, Mh, Pacheco Alvis PM, Botero, R, Saenz, O, Bergovec, M, Padovan, M, Vucic, N, Samarzija, M, Chlumsky, J, Spacek, R, Klimsa, Z, Gregor, P, Povolny, J, Podpera, I, Holm, F, Lang, P, Matoska, P, Sabl, P, Spinar, J, Spac, J, Husted, S, Avnstrom, S, Rasmussen, S, Christensen, A, Guindy, R, Hassanein, M, Paumets, M, Meriste, S, Ferrari, E, Achkar, A, Azarian, R, Meneveau, N, Lorut, C, Mouallem, J, Crestani, B, Proton, A, Salmeron, S, Lerousseau, L, Mottier, D, Wahl, D, Siafakas, N, Papadimitriou, D, Katis, K, Katsaris, G, Gaga, A, Damianos, A, Tipparaju, S, Kalkunte, S, Vidhut, J, Kalashetti, S, Mehta, P, Talwar, D, Ramanathan, R, Mishra, R, Zeltzer, D, Lahav, M, Brenner, B, Caraco, Y, Elias, M, Piovella, F, Barone, M, Poggio, R, Palla, A, Ghirarduzzi, A, Pini, M, Lodigiani, C, Prandoni, Paolo, Agnelli, G, Imberti, D, Scannapieco, G, Salvi, A, Bautista, E, Diaz, J, Mercado, R, Ranero, A, Rodriguez, D, Jerjes, C, Villeda Espinoza, E, Van Der Meer, J, Ijfering, W, Van Marwijk Kooy, M, Boersma, W, Van Leendert, R, Kroon, C, Dullemond Westland, A, Viergever, P, Kuipers, A, Grootenboers, M, Creemers, J, Pieters, W, De Munck, D, Timmer, H, Jackson, S, Sandset, P, Meyer, P, Kristiansen, T, Portugal, J, Paz, E, Salazar, D, Chavez, W, Castillo, L, De Guia, T, Lenora, F, Tomkowski, W, Kloczko, J, Rybak, Z, Gaciong, Z, Sobkowicz, B, Pruszczyk, P, Nizankowski, R, Mirek Bryniarska, E, Kukla, P, Reis, A, França, A, Cortez, M, Sa, J, Santos, F, Marques, Ma, Gordeev, I, Gendlin, G, Yablonsky, P, Sokurenko, G, Soroka, V, Lusov, V, Markov, V, Shvats, Y, Katerlnitskiy, I, Lapin, O, Lyamina, N, Subbotin, Y, Kim, I, Zilber, E, Kchaisheva, L, Poliacik, P, Macek, V, Pretorius, Jp, Abdullah, I, Basson, M, Bollinger, C, Breedt, J, Gani, M, Jansen, J, Le Roux, G, Nortje, H, Van Der Linder, M, Van Zyl, L, Viljoen, J, Bruning, A, Pujol Farriols, R, Raguer, E, Nuffal, D, Sanchez Rodriguez, A, Eriksson, H, Almgren, T, Carlsson, A, Elf, J, Olsson, Cg, Aagesen, J, Savas, I, Sahin, A, Erdogan, Y, Ozhan, M, Ongen, G, Celikel, T, Turker, H, Arseven, O, Tuncay, E, Ozacar, R, Gudz, I, Nykonenko, O, Skupyy, O, Kovalskyy, I, Prasol, V, Cohen, A, Rodriguez Cintron, W, Gurka, D, Bradley, J, Oliver, G, Spyropoulos, A, Lerner, R, Fulmer, J, Lu, Np, Wright, P, Han, D, Servi, R, Nadar, V, Quaranta, A, Gehring, J, Ginsberg, R, Jacobson, A, Colan, D, Vanway, C, Gurza, E, Braslow, B, Shorr, A, Rehm, J, Martin, J, Sellers, M, Concha, M, Gordon, I, Pullman, J, Moran, J, Welker, J, Panzarella, P, Mullins, M, Willms, D, Mcgrew, F, Turki, M, Menajovsky, L., Epidemiologie, MUMC+: KIO Kemta (9), RS: CAPHRI School for Public Health and Primary Care, Amsterdam Cardiovascular Sciences, Vascular Medicine, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), SA Pathology at Flinders Medical Center (ASG), Flinders University, Department of Epidemiology (MHP), Maastricht University [Maastricht], College of Public Health (CPH), University of Oklahoma (OU), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)

Subjects
Male, MESH: Pulmonary Embolism, Oligosaccharides, MESH: Factor X, 030204 cardiovascular system & hematology, MESH: Intention to Treat Analysis, MESH: Aged, 80 and over, 0302 clinical medicine, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Warfarin, Aged, 80 and over, MESH: Aged, education.field_of_study, Idrabiotaparinux, MESH: Middle Aged, General Medicine, Heparin, Middle Aged, Intention to Treat Analysis, 3. Good health, Pulmonary embolism, Acute Disease, MESH: Acute Disease, Drug Therapy, Combination, Female, medicine.drug, Adult, medicine.medical_specialty, MESH: Enoxaparin, Adolescent, Population, Biotin, MESH: Anticoagulants, Double blind, 03 medical and health sciences, Double-Blind Method, Internal medicine, MESH: Biotin, medicine, Humans, Enoxaparin, education, Aged, MESH: Adolescent, MESH: Humans, Intention-to-treat analysis, business.industry, Warfarin, Anticoagulants, MESH: Adult, Odds ratio, medicine.disease, MESH: Male, Surgery, MESH: Drug Therapy, Combination, Factor X, Pulmonary Embolism, business, MESH: Female, MESH: Oligosaccharides, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; BACKGROUND: Treatment of pulmonary embolism with low-molecular-weight heparin and vitamin K antagonists, such as warfarin, is not ideal. We aimed to assess non-inferiority of idrabiotaparinux, a reversible longlasting indirect inhibitor of activated factor X, to warfarin in patients with acute symptomatic pulmonary embolism. METHODS: In our randomised, double-blind, double-dummy, non-inferiority trial, we enrolled adults with objectively documented acute symptomatic pulmonary embolism attending 291 centres in 37 countries. We excluded patients who were pregnant, had active bleeding, kidney failure, or malignant hypertension, or were at high risk of death, bleeding, or adverse reactions to study drugs. We randomly allocated patients to receive 5-10 days' enoxaparin 1*0 mg/kg twice daily followed by subcutaneous idrabiotaparinux (starting dose 3*0 mg) or adjusted-dose warfarin (target international normalised ratio 2*0-3*0); regimens lasted 3 months or 6 months dependent on clinical presentation. Block randomisation was done with a central interactive computerised system, stratified by study centre and intended treatment duration. The primary efficacy outcome was recurrent venous thromboembolism at 99 days after randomisation. We estimated the odds ratio and 95% CI with a Mantel-Haenzsel χ(2) analysis (non-inferiority margin 2*0) in the intention-to-treat population. The main safety outcome was clinically relevant bleeding (major or non-major) in all patients at day 99. This study is registered with ClinicalTrials.gov, number NCT00345618. FINDINGS: Between Aug 1, 2006, and Jan 31, 2010, we enrolled 3202 patients aged 18-96 years. 34 (2%) of 1599 patients randomly allocated to receive enoxaparin-idrabiotaparinux and 43 (3%) of 1603 patients randomly allocated to receive enoxaparin-warfarin had recurrent venous thromboembolism (odds ratio 0*79, 95% CI 0*50-1*25; p(non-inferiority)=0*0001). 72 (5%) of 1599 patients in the enoxaparin-idrabiotaparinux group and 106 (7%) of 1603 patients in the enoxaparin-warfarin group had clinically relevant bleeding (0*67, 0*49-0*91; p(superiority)=0*0098). We noted similar differences in outcomes in those patients treated to 6 months. INTERPRETATION: Idrabiotaparinux could provide an attractive alternative to warfarin for the long-term treatment of pulmonary embolism, and seems to be associated with reduced bleeding. FUNDING: Sanofi-Aventis (Paris, France).

Published
2012
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61. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism

Author

Agnelli, G, Berkowitz, S, Bounameaux, H, Büller, Hr, Cohen, A, Gallus, A, Lensing, Aw, Misselwitz, F, Haskell, L, Prins, Mh, Raskob, G, Schellong, S, Bauersachs, R, van Bellen, B, Boda, Z, Borris, L, Brenner, B, Brighton, T, Chlumsky, J, Davidson, B, Decousus, H, Eriksson, H, Jacobson, B, Kakkar, A, Kwong, Yl, Lee, Lh, Meijer, K, van der Meer, J, Minar, E, Monreal, M, Piovella, F, Sandset, Pm, Smith, M, Tomkowski, W, Verhamme, P, Wang, Y, Wells, P, Brandjes, D, Mac Gillavry, M, Otten, Hm, Carlsson, A, Laporte, S, Schulman, S, Gent, M, Turpie, A, Martinelli, I, Segers, A, Muhlhofer, E, Tewes, M, Trajanovic, M, Muller, K, Kim, C, Gebel, M, Benson, A, Pap, Af, Godrie, J, Horvat Broecker, A, Spadari, G, Peters Wulf, C, Roig, J, Baker, R, Bianchi, A, Blombery, P, Campbell, P, Carroll, P, Geraghty, R, Chong, B, Ramanathan, S, Archis, C, Coughlin, P, Salem, H, Crispin, P, Dean, M, Soni, R, Denaro, C, Kubler, P, Coghlan, D, Gan, Te, Tran, H, Coleman, C, Jackson, D, Khalafallah, A, Leahy, M, Leyden, M, Leyden, D, Sturtz, C, Mccann, A, Gibbs, H, Mcrae, S, Richards, B, Ward, C, Curnow, J, Baghestanian, M, Erdogmus, B, Samaha, E, Nikoupayan Mofrad, M, Hirschl, M, Sturm, W, Kirchmair, R, Marschang, P, Drexel, H, Mathies, R, Pilger, E, Brodmann, M, Weltermann, A, Buche, M, Demelenne, J, Gustin, M, Hainaut, P, Pothen, L, de Leersnyder, J, Motte, S, Schroë, H, Sprynger, M, Peerlinck, K, Delcroix, M, Vermassen, F, Verstraeten, P, Smet, V, Vossaert, R, Panico, M, Costa, C, Blondal, J, Kovacs, M, Rodger, M, Carrier, M, Wong, T, Bi, J, Chen, Z, Chen, R, Jing, Zc, He, J, Liu, C, Liu, S, Long, S, Ma, Y, Shao, Y, Wang, C, Yang, Yh, Xie, C, Xu, J, Ying, K, Zhihong, L, Hola, D, Jirat, S, Vitovec, M, Kovářová, K, Gilík, J, Dosál, J, Mandakova, E, Matoška, P, Podpera, I, Podperova, M, Spacek, R, Urbanova, R, Tuxen, C, Sukles, K, Pietila, K, Vesanen, M, Achkar, A, Agraou, B, Aquilanti, S, Rifaï, A, Berremili, T, Brisot, D, Brousse, C, Tarodo, P, Bura, A, Amid Lacombe, C, Malloizel, J, Boulon, C, Alavoine, L, Crestani, B, Mismetti, P, Buchmuller, A, Accassat, S, Elias, A, Elias, M, Emmerich, J, Ferrari, E, Guérin, T, Beaka, P, Lacroix, P, Szwebel, Ta, Benhamou, Y, de Maistre, E, Falvo, N, Mahe, I, Meneveau, N, Schiele, F, Meyer, G, Sanchez, O, Planquette, B, Mottier, D, Le Moigne, E, Couturaud, F, Parent, F, Pernod, G, Imbert, B, Elkouri, D, Dary, M, Queguiner, A, Quere, I, Galanaud, Jp, Roy, Pm, de Boisjolly Bonnefoi JM, Schmidt, J, Breuil, N, Heuser, S, Sevestre, Ma, Simoneau, G, Bergmann, Jf, Stephan, D, Trinh Duc, A, Gaillardou, A, Grange, C, Fassier, T, Wahl, D, Baron Von Bilderling, P, Kuhlencordt, P, Beyer Westendorf, J, Halbritter, K, Werth, S, Diehm, C, Lawall, H, Eifrig, B, Espinola Klein, C, Weisser, G, Giannitsis, E, Haering, Hu, Hasslacher, C, Herrmann, T, Hoffmann, U, Czihal, M, Horacek, T, Ibe, M, Bauer, A, Kieback, A, Landgraf, H, Lindhoff Last, E, Malyar, N, Petermann, W, Potratz, J, Ranft, J, Röcken, M, Pomper, L, Frommhold, R, Schwaiblmair, M, Berghaus, T, Taute, B, Lau, Yk, Tse, E, Olah, Z, Farkas, K, Kolossváry, E, Gurzó, M, Kis, E, Kovács, A, Landi, A, Lupkovics, G, Pecsvarady, Z, Riba, M, Sipos, G, Parakh, R, Sembiring, R, Barton, J, Goldstein, L, Gavish, D, Hoffman, R, Hussein, O, Inbal, A, Lishner, M, Elis, A, Lugassy, G, Varon, D, Zeltser, D, Rogowski, O, Steinvil, A, Zisman, D, Ageno, W, Ambrosio, G, Cattaneo, M, D'Angelo, A, Ghirarduzzi, A, Lotti, M, Pierfranceschi, Mg, Lodigiani, C, Palareti, G, Barone, M, Beltrametti, C, Porreca, E, Prandoni, Paolo, Spiezia, L, Quintavalla, R, Cho, Wh, Ha, Jw, Kim, Hs, Park, K, Sime, I, Miliauskas, S, Petrauskiene, R, Sathar, J, Beeker, A, Ten Cate, H, De Groot, M, Kamphuisen, P, Douma, R, Kooy, Mv, Coenen, J, Mäkelburg, A, Knol, M, Tichelaar, V, Harper, P, Knottenbelt, E, Ockelford, P, Young, L, Royle, G, Simpson, D, Chunilal, S, Ghanima, W, Foyn, S, Tveit, A, Abola, Mt, Adamiec, R, Gorski, P, Kloczko, J, Lewczuk, J, Nowak, M, Musial, J, Wronski, J, Ng, Hj, Adler, D, Becker, Jh, Ellis, G, Isaacs, R, Bloy, B, Allie, R, Eckstein, F, van Rensburg JH, Schmidt, S, Siebert, H, Zyl, L, Carrera, M, Del Campo, F, Diego, I, Garcia Bragado, F, Jiménez, D, Sánchez Álvarez, J, Redondo, M, Roman Sanchez, P, Villalta, J, Villegas Scivetti, M, Jonson, T, Tygesen, H, Lapidus, L, Ottosson, E, Själander, A, Asmis, L, Banyai, M, Heidemann, M, Baumgartner, I, Righini, M, Frank, U, Hayoz, D, Periard, D, Chang, Wt, Chiu, K, Wang, Ky, Weng, Zc, Angchaisuksiri, P, Pothirat, C, Rojnuckarin, P, Solis, J, Hunt, B, Luckit, J, Albrecht, C, Banish, D, Feinbloom, D, Botnick, W, Chen, D, Dexter, J, Ettinger, N, Gleeson, J, Jaffer, A, Joseph, S, Kennedy, M, Krell, K, Lavender, R, Lyons, R, Moll, S, Nadar, V, Darrow, K, Hardman, V, Rathbun, S, Rehm, J, Rodriguez Cintron, W, Stevens, K, Wright, P, Ramaswamy, M., ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, Other departments, Epidemiologie, MUMC+: KIO Kemta (9), RS: CAPHRI School for Public Health and Primary Care, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), Department of Epidemiology (MHP), Maastricht University [Maastricht], Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Service d'angiologie et d'hémostase (MR), Hôpital Universitaire de Genève, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
MESH: Pulmonary Embolism, Male, Vitamin K, Administration, Oral, Pulmonary Embolism/drug therapy/mortality, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, chemistry.chemical_compound, 0302 clinical medicine, Rivaroxaban, Edoxaban, Recurrence, Hemorrhage/chemically induced, 030212 general & internal medicine, Vitamin K/antagonists & inhibitors, Enoxaparin/adverse effects/therapeutic use, MESH: Treatment Outcome, MESH: Aged, ddc:616, MESH: Middle Aged, Hazard ratio, General Medicine, MESH: Follow-Up Studies, Vitamin K antagonist, MESH: Thiophenes, Middle Aged, Thrombosis, Morpholines/adverse effects/therapeutic use, 3. Good health, Pulmonary embolism, MESH: International Normalized Ratio, Treatment Outcome, Anesthesia, MESH: Administration, Oral, Administration, Combination, Apixaban, Drug Therapy, Combination, Female, MESH: Hemorrhage, medicine.drug, Oral, MESH: Enoxaparin, medicine.drug_class, Morpholines, Anticoagulants/adverse effects/therapeutic use, MESH: Morpholines, Hemorrhage, Thiophenes, MESH: Anticoagulants, 03 medical and health sciences, Drug Therapy, medicine, Humans, International Normalized Ratio, Enoxaparin, MESH: Kaplan-Meier Estimate, Aged, MESH: Humans, business.industry, MESH: Vitamin K, Anticoagulants, medicine.disease, MESH: Male, MESH: Recurrence, Regimen, MESH: Drug Therapy, Combination, chemistry, Thiophenes/adverse effects/therapeutic use, business, Pulmonary Embolism, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

International audience; BACKGROUND: A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism. METHODS: In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. RESULTS: Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P=0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standard-therapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P=0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003). Rates of other adverse events were similar in the two groups. CONCLUSIONS: A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.).

Published
2012
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65. Practical management of patients on apixaban: a consensus guide

Author

Ward, C, Conner, G, Donnan, G, Gallus, A, Mcrae, S, Ward, C, Conner, G, Donnan, G, Gallus, A, and Mcrae, S

Abstract

BACKGROUND: Atrial fibrillation (AF) is a common tachyarrhythmia in Australia, with a prevalence over 10% in older patients. AF is the leading preventable cause of ischaemic stroke, and strokes due to AF have a higher mortality and morbidity. Stroke prevention is therefore a key management strategy for AF patients, in addition to rate and rhythm control. Anticoagulation with warfarin has been an enduring gold standard for stroke prevention in NVAF patients. In Australia, three novel oral anticoagulants (NOACs), apixaban, dabigatran and rivaroxaban are now approved and reimbursed for stroke prevention in patients with non-valvular AF (NVAF). International European Cardiology guidelines now recommend either a NOAC or warfarin for NVAF patients with a CHA2DS2-VASc score ≥2, unless contraindicated. Apixaban is a direct factor Xa inhibitor with a 12-hour half-life and 25% renal excretion that was found in a large trial of NVAF patients to be superior to warfarin in preventing stroke or systemic embolism. In this trial population, apixaban also resulted in less bleeding and a lower mortality rate than warfarin. METHODS: Clinical experience with apixaban outside of clinical trials has been limited, and there is currently little evidence to guide the management of bleeding or invasive procedures in patients taking apixaban. The relevant currently available animal and ex vivo human data were collected, analyzed and summarized. RESULTS: This multi-disciplinary consensus statement has been written to serve as a guide for healthcare practitioners prescribing apixaban in Australia, with a focus on acute and emergency management. CONCLUSIONS: The predictable pharmacokinetics and minimal drug interactions of apixaban should allow for safe anticoagulation in the majority of patients, including temporary interruption for elective procedures. In the absence of published data, patients actively bleeding on apixaban should receive standard supportive treatment. Quantitative assays of a

Published
2013

66. Factor VIII gene (F8) mutation and risk of inhibitor development in nonsevere hemophilia A

Author

Eckhardt, CL, van Velzen, AS, Peters, M, Astermark, J, Brons, PP, Castaman, G, Cnossen, Marjon, Dors, N, Escuriola-Ettingshausen, C, Hamulyak, K, Hart, DP, Hay, CRM, Haya, S, van Heerde, WL, Hermans, C, Holmstrom, M, Jimenez-Yuste, V, Keenan, RD, Klamroth, R, Laros-Van Gorkom, BAP, Leebeek, Frank, Liesner, R, Makipernaa, A, Male, C, Mauser-Bunschoten, E, Mazzucconi, MG, Mcrae, S, Meyer, K, Mitchell, M, Morfini, M, Nijziel, M, Oldenburg, J, Peerlinck, K, Petrini, P, Platokouki, H, Reitter-Pfoertner, SE, Santagostino, E, Schinco, P, Smiers, FJ, Siegmund, B, Tagliaferri, A, Yee, TT, Kamphuisen, PW, van der Bom, JG (Anske), Fijnvandraat, K, Eckhardt, CL, van Velzen, AS, Peters, M, Astermark, J, Brons, PP, Castaman, G, Cnossen, Marjon, Dors, N, Escuriola-Ettingshausen, C, Hamulyak, K, Hart, DP, Hay, CRM, Haya, S, van Heerde, WL, Hermans, C, Holmstrom, M, Jimenez-Yuste, V, Keenan, RD, Klamroth, R, Laros-Van Gorkom, BAP, Leebeek, Frank, Liesner, R, Makipernaa, A, Male, C, Mauser-Bunschoten, E, Mazzucconi, MG, Mcrae, S, Meyer, K, Mitchell, M, Morfini, M, Nijziel, M, Oldenburg, J, Peerlinck, K, Petrini, P, Platokouki, H, Reitter-Pfoertner, SE, Santagostino, E, Schinco, P, Smiers, FJ, Siegmund, B, Tagliaferri, A, Yee, TT, Kamphuisen, PW, van der Bom, JG (Anske), and Fijnvandraat, K

Published
2013

67. Validation of whole blood impedance aggregometry as a new diagnostic tool for HIT: Results of a large Australian study.

Author

Ward C., McRae S., Baker R., Mollee P., Kershaw G., Joseph J., Tran H., Morel-Kopp M.-C., Tan C.W., Brighton T.A., Ward C., McRae S., Baker R., Mollee P., Kershaw G., Joseph J., Tran H., Morel-Kopp M.-C., Tan C.W., and Brighton T.A.

Abstract

Heparin-induced thrombocytopenia (HIT) remains a challenge, with diagnosis confirmed only by functional assays. The gold standard 14C-serotonin release assay (SRA) is highly sensitive but technically challenging and unsuitable for routine use. We conducted a large study to validate whole blood impedance aggregometry (WBIA) as a suitable diagnostic tool for HIT. WBIA and SRA were used to test 181 samples positive for H-PF4 antibodies by PaGIA or ELISA. Using the same high responder donor, 77 samples were positive by WBIA (aggregation with low-dose but not high-dose heparin). Using the strict definition for SRA positivity, 72 samples were true HIT. In nine samples, serotonin release with high-dose heparin dropped by > 50% but was still >20%; these were retested after a one-half dilution and 8/9 became positive. Ten other samples were discrepant between the two assays: one strongly positive (89% release) and six weakly positive samples by SRA (average release 56%) were WBIA negative. When these samples were retested using a random donor, only two remained SRA positive. Three samples were strongly WBIA positive but SRA negative; two were retested by SRA with 0.5IU/ml heparin and one became positive. Under controlled conditions, using the same selected high-responder donor, WBIA and SRA performed similarly with slightly increased sensitivity of the WBIA when using the strict definition of SRA positivity. WBIA is easy to perform with rapid turn-around time and warrants a multi-laboratory trial to complete its validation as a confirmatory assay for platelet-activating HIT antibodies. © Schattauer 2012.

Published
2012

68. A multi-centre, single-arm, open-label study evaluating the safety and efficacy of fixed dose rituximab in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (R-ITP1000 study) and exploring rituximab response with the FcGammaR3A polymorphisms.

Author

McRae S., Catalano J., Grigg A., Thurley D., Gandhi M., Tran H., Nourse J.P., Lea R., Brighton T.A., McRae S., Catalano J., Grigg A., Thurley D., Gandhi M., Tran H., Nourse J.P., Lea R., and Brighton T.A.

Abstract

Background: Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by low platelet count and mucocutaneous bleeding. Approximately 25-30% of adult patients with acute ITP develop chronicity; 30% of chronic ITP patients become refractory to corticosteroids and require additional therapy. As B-cells play an important pathophysiological role in autoimmune disease, rituximab, a chimeric anti-CD20 monoclonal antibody which depletes CD20+ B-cells has been used in chronic ITP. A dosing regimen based on lymphoma therapy (375 mg/m2 weekly x 4) has shown efficacy (~38% Overall Response Rate-ORR) in adults in this context. Whether this schedule is optimal in autoimmune disease, in which the burden of pathological B-cells is low, is unknown. In this study we explored an abbreviated rituximab schedule, consistent with the approved rheumatoid arthritis dosing. We also explored inherited polymorphisms in FcGammaR3A (FCGR3A) as it has been shown to correlate with response to rituximab. AIM: The primary objective of this study was to determine the ORR, at week 8, among adults (>= 18 years) with chronic or relapsing ITP (platelet count > 10 x 109/L and <= 50 x 109/L) according to the ASH guidelines, who received rituximab 1000 mg intravenous (IV) on days 1 and 15. A laboratory sub-study investigated the relationship between the FCGR3A-V/F158 polymorphisms and response to rituximab. METHOD(S): Patients received planned doses of rituximab and were followed-up for a minimum of 12 weeks. Assessments and procedures at mandatory follow-up visits occurring on weeks 8, 12, 26, 39 and 52 included physical examination, vital signs, FBC and serum chemistry. ORR was defined as the proportion of patients achieving a Complete Response (CR, platelet count > 150x109/L) or Partial Response (PR, > 50 x 109/L) at weeks 8 and 12 with 2 consecutive measurements, confirmed at least 2 weeks apart. Simon's 2-stage design was used to determine if the ORR was more likely to be <= 38

Published
2012

69. Palliative care on Manitoulin Island. Views of family caregivers in remote communities

Author

McRae, S., Caty, S., Nelder, M., and Picard, L.

Subjects
Aged, 80 and over, Ontario, Palliative Care, Medically Underserved Area, Social Support, Consumer Behavior, Middle Aged, Health Services Accessibility, Caregivers, Humans, Rural Health Services, Attitude to Health, Research Article, Aged, Quality of Health Care
Abstract

OBJECTIVE: To describe family caregivers' experiences with palliative care services in rural communities. DESIGN: Qualitative study. SETTING: Manitoulin Island, Ont. PARTICIPANTS: Thirteen family caregivers of 12 deceased patients who had received palliative care services. METHOD: Twenty-five family caregivers were recruited by mail and local newspaper. Eight were excluded because they lived off the Island or were too recently bereaved; one declined an interview; and three were excluded by researchers. Initial contact was by telephone; those retained (13 people) were interviewed at home. Interviews were conducted by the same researcher using a semistructured interview guide. All interviews were audiotaped and transcribed, and content was analyzed. MAIN FINDINGS: Three interwoven themes were identified: access to services, quality of services, and support and caring. Hospital and community-based services were accessed with ease at the local level; difficulties were noted when accessing services in tertiary care centres. Participants were generally grateful for and pleased with services received. Two areas of concern raised by participants were communication and pain and symptom control. Participants suggested to the Ministry of Health ways to improve rural palliative care services. More public funding for in-home palliative care services was identified as a priority. CONCLUSION: Participants thought good services and supportive care at the local level made up for difficulties in accessing and using palliative services in tertiary care centres. Community spirit and culture were seen as making situations more bearable.

Published
2000

70. Rapid diagnosis of heparin-induced thrombocytopenia (HIT) by whole blood impedance aggregometry: Results of the Australian multi centre study.

Author

Joseph J., Tran H., Kershaw G., Coyle L., Ward C., Morel-Kopp M.-C., Tan C.W., Brighton T., McRae S., Mollee P., Joseph J., Tran H., Kershaw G., Coyle L., Ward C., Morel-Kopp M.-C., Tan C.W., Brighton T., McRae S., and Mollee P.

Abstract

HIT is a serious complication and remains a challenge for diagnostic laboratories and clinicians. Only a subset of IgG antibodies to complexes of platelet factor 4 (PF4) and heparin (H) trigger the clinical manifestations of HIT by activating platelets, and these can only be identified with platelet activation/aggregation (functional) assays. The 14C-serotonin release assay (SRA), the gold standard in HIT diagnosis, is highly sensitive but only performed in one Australian laboratory and hence unsuitable for routine use. We have developed a whole blood impedance aggregometry (WBIA-Multiplate) and in a small cohort of HIT-antibody positive patients have shown it to be superior to light transmission aggregometry and as sensitive as the SRA. We obtained ethics approval to conduct a multi-centre study to validate the WBIA as a suitable diagnostic tool in HIT. We have tested 158 samples positive for H-PF4 antibodies by PaGIA or ELISA. Using a selected donor (high responder), 65 samples were positive by WBIA (aggregation with low dose 0.5 IU/mL H but not with high dose). SRA was performed using the same donor platelets, serotonin was released from 80 samples (> 20% release with 0.1 IU/ mL H) with only 70 true HIT samples (release < 20% with 100 IU/ mL H). Eleven samples exhibited discrepant results: one strongly positive (89% release) and seven weakly positive by SRA (average release 40%, range 22-67%) were WBIA negative. These eight samples were retested using a random donor, only three remained SRA positive. Three samples were SRA negative but strongly WBIA positive. These discrepant cases will be analysed for clinical outcomes and potential interfering substances. In this multi-centre study, with a selected donor, WBIA had a sensitivity of 88.6% which could rise to 95% using random donors for SRA, a specificity of 96.6% and a PPV of 95.4%. WBIA is easy to perform with rapid turn-around time and warrants further investigation as confirmatory assay for platelet-activating

Published
2011

71. Recommendations for the prevention of pregnancy-associated venous thromboembolism.

Author

Mclintock C., Dekker G., Mcdonnell N., Mcrae S., Muller P., Walters B.N., Young L., Brighton T., Tran H., Chunilal S., Mclintock C., Dekker G., Mcdonnell N., Mcrae S., Muller P., Walters B.N., Young L., Brighton T., Tran H., and Chunilal S.

Abstract

Pregnancy is a risk factor for venous thromboembolism (VTE), an important cause of maternal morbidity and mortality. Although there is a 4-5-fold increased risk compared to that of nonpregnant women of the same age, the absolute risk is low at no more than two episodes of VTE per 1000 pregnancies. There is uncertainty about which women require thromboprophylaxis during pregnancy or postpartum because of a lack of data from appropriate clinical trials. For this reason, recommendations for prophylaxis should be made only after explaining the available evidence to the patient and taking into account her perception of the balance of risk and benefit in thromboprophylaxis. The aim of these recommendations is to provide clinicians with practical advice to assist in decisions regarding thromboprophylaxis in women considered to be at risk of VTE during pregnancy and the postpartum. The authors are clinicians from across New Zealand and Australia representing the fields of haematology, obstetric medicine, anaesthesiology, maternal-fetal medicine and obstetrics. Authors were invited to review the relevant literature and then worked collaboratively to devise recommendations and resolve areas of controversy. The recommendations contained herein were reached by consensus and represent the opinion of the panel. The absence of randomised clinical trials in this area limits the strength of evidence that can be used, and it is acknowledged that they represent level C evidence. The panel advocates for appropriate clinical studies to be carried out in this patient population to address the inadequacy of present evidence. © 2011 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2011 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Published
2011

72. Recommendations for the diagnosis and treatment of deep venous thrombosis and pulmonary embolism in pregnancy and the postpartum period.

Author

Mcdonnell N., Walters B.N., Young L., Mcrae S., Tran H., Mclintock C., Brighton T., Chunilal S., Dekker G., Muller P., Mcdonnell N., Walters B.N., Young L., Mcrae S., Tran H., Mclintock C., Brighton T., Chunilal S., Dekker G., and Muller P.

Abstract

Venous thromboembolism (VTE) in pregnancy and the postpartum is an important cause of maternal morbidity and mortality; yet, there are few robust data from clinical trials to inform an approach to diagnosis and management. Failure to investigate symptoms suggestive of pulmonary embolism (PE) is a consistent finding in maternal death enquiries, and clinical symptoms should not be relied on to exclude or diagnose VTE. In this consensus statement, we present our recommendations for the diagnosis and management of acute deep venous thrombosis (DVT) and PE. All women with suspected DVT in pregnancy should be investigated with whole leg compression ultrasonography. If the scan is negative and significant clinical suspicion remains, then further imaging for iliofemoral DVT maybe required. Imaging should be undertaken in all women with suspected PE, as the fetal radiation exposure with both ventilation/perfusion scans and CT pulmonary angiography is within safe limits. Low-molecular-weight heparin (LMWH) is the preferred therapy for acute VTE that occur during pregnancy. In observational cohort studies, using once-daily regimens appears adequate, in particular with the LMWH tinzaparin; however, pharmacokinetic data support twice-daily therapy with other LMWH and is recommended, at least initially, for PE or iliofemoral DVT in pregnancy. Treatment should continue for a minimum duration of sixmonths, and until at least sixweeks postpartum. Induction of labour or planned caesarean section maybe required to allow an appropriate transition to unfractionated heparin to avoid delivery in women in therapeutic doses of anticoagulation. © 2011 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2011 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Published
2011

76. Comparison of von Willebrand factor ( VWF) activity levels determined by Hemos IL AcuStar assay and Hemos IL LIA assay with ristocetin cofactor assay by aggregometry.

Author

Sagheer, S., Rodgers, S., Yacoub, O., Dauer, R., Mcrae, S., and Duncan, E.

Subjects
VON Willebrand factor, RISTOCETIN, COFACTORS (Biochemistry), INTERLEUKINS, IMMUNOASSAY, CHEMILUMINESCENCE assay, DIAGNOSIS
Abstract

Introduction Diagnosis of von Willebrand disease ( VWD) requires quantitative as well as qualitative determination of von Willebrand factor ( VWF) levels. For functional assessment of VWF, ristocetin cofactor assay by aggregometry is considered to be the gold standard. However, need for technical expertise, labour intensiveness, difficult standardization and high intra- and inter- assay variabilities are some of the limitations of this methodology. Various assays for determination of VWF adhesive function using different methodologies have been developed in recent years. Aim To evaluate the Hemos IL AcuStar chemiluminescence assay ( VWF: RCo[Acu]) and the Hemos IL latex immunoassay ( VWF:act) as diagnostic tests for VWD and identification of type 2 VWD in comparison with the ristocetin cofactor assay performed by aggregometry ( VWF: RCo[Agg]). Methods Results from 96 samples analysed by VWF: RCo[Acu] and 128 samples by VWF:act were compared with VWF: RCo[Agg]. Sixty of these samples (25 normal, 17 type 1 and 18 type 2) were analysed by all three assays. Results VWF: RCo[Acu] showed excellent agreement with VWF: RCo[Agg], and readily identified all type 2 VWD samples tested. VWF:act showed reasonable agreement with VWF: RCo[Agg] for most patients, but had a slightly lower sensitivity for detection of type 2 VWD. Conclusion VWF: RCo[Acu] assay has the potential to replace VWF: RCo[Agg] for the diagnosis of VWD. [ABSTRACT FROM AUTHOR]

Published
2016
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77. Comparison of strip cropping with field cropping management, Ridge till & strip cropping field days - final report

Author

Omielan, J., McRae, S., Samson, R., Quinn, J., Gasser, P. Y, and Farmer Cooperators

Subjects
fungi, food and beverages, ridge till, field management, strip management, strip cropping
Abstract

From 1993-1996, an on-farm participatory research project was conducted by the Ontario Ridge Till and Strip Crop Club in Southwestern and Eastern Ontario. The program assessed field versus strip crop management of corn and soybean systems and, in the final year of the project, corn and winter wheat systems. Strip cropping as practiced by the members of the Ontario Ridge Till and Strip Crop Club is a narrow strip intercropping system consisting of 3-6 corn rows with soybeans or winter wheat. The objective of these strip crop management systems is to increase crop productivity while at the same time conserving soil resources on the farm. In corn-soybean strip cropping trials, increased light interception by outside rows of corn resulted in yield increases on 3 out of 4 sites. These yield increase were largely confined to the outside rows. Where individual outside row yields were measured, increases of approximately 30% over inner rows, or field managed rows were observed Soybean yields under strip management systems were reduced on 5 out of 7 sites. Both variety selection and row orientation appeared to be important factors for minimizing yield losses in soybeans. On all of the sites where yield losses were recorded, corn and soybeans were planted in a north-south direction in 6-row strips. The average yield loss for this system was 14.7%. Individual row samplings in these plots clearly indicated that the majority of the yield loss in soybeans was a result of shading in rows adjacent to corn rows. Losses of approximately 30% were recorded in the westernmost row which was also etiolated and delayed in maturity as a result of excessive shading. The shading effect was less significant on the eastern side where yield losses averaged 13% in the outside row. Overall, yield losses in soybeans planted with a north-south orientation, particularly those in the Eastern Ontario studies, appeared to be too large to be compensated for by any potential corn yield increases. Better results were obtained with an east-west orientation as the shading effect is less prevalent. Tall soybean varieties and varieties susceptible to white mold should be avoided when strip cropping in order to reduce the impacts of shading. A strip management system for winter wheat and corn appears to be the most promising form of strip crop management evaluated during the four years of on-farm research. As in the case of corn, large increases in yield on the outside border rows (65% average increase) of winter wheat were responsible for increasing the wheat strip yield. The 3 row corn strip (with two out of three rows as border rows) was estimated to increase yields by 21% over field managed corn. When grown together in a strip cropping system, both crops appear to have the potential to reliably over yield which makes the system more attractive that the corn-soy system. From an agronomic and environmental standpoint, winter wheat appears to be an excellent strip crop companion for corn in that it completes its growth cycle well ahead of corn, is more compatible than soybeans with corn fertilizer and weed control programs, and is an extremely effective erosion control strategy. The benefits of this system are manifold, and further study into its effects could enable the widespread adoption of this conservation farming practice on farms.

Published
1997

78. Abstract No. 60: Effect of needle size on pneumothorax and chest tube placement rates in CT-guided percutaneous lung biopsies performed using a coaxial method: a large single-center study

Author

Kuban, J.D., primary, Philip, A.S., additional, Chen, G.J., additional, Joseph, E., additional, Tam, A., additional, Wallace, M.J., additional, Avritscher, R., additional, Ahrar, J.U., additional, Ahrar, K., additional, Murthy, R., additional, Mahvash, A., additional, McRae, S., additional, and Gupta, S., additional

Published
2012
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79. Reasons for attending and not attending a support group for recipients of implantable cardioverter defibrillators and their carers

Author

Williams, Anne, Young, J., Nikoletti, S., McRae, S., Williams, Anne, Young, J., Nikoletti, S., and McRae, S.

Abstract

There is evidence to suggest that people who have an implantable cardioverter defibrillator and their caregivers experience psychological distress. This qualitative descriptive study explored the experiences, concerns and needs of recipients of implantable cardioverter defibrillators and their caregivers who attended or did not attend a support group organized by a public hospital located in Perth, Western Australia, Australia. Eleven recipients of implantable cardioverter defibrillators and their caregivers participated in this study. Among those who attended the support group, four major themes were identified: providing information, connecting with others, helping others and attendance. Explanations for non-attendance included difficulties attending because of the location, not wanting to be reminded about the implantable cardioverter defibrillator, and a perception, among younger recipients, that the support group was comprised of mainly older recipients with whom they had little in common.

Published
2004

81. Mammography: Comment

Author

Hamilton, R.J. and McRae, S.

Subjects
Departments: Letters
Published
1992

83. The red gape of the nestling cuckoo (Cuculus canorus) is not a supernormal stimulus for three common hosts.

Author

Nobel, D. G., Davies, N. B., Hartley, Ian R., McRae, S. B., Nobel, D. G., Davies, N. B., Hartley, Ian R., and McRae, S. B.

Abstract

The bright red gape of the nestling common cuckoo Cuculus canorus has often been supposed to act as a supernormal stimulus to elicit provisioning from its foster parents. Parents of three main host species were tested for their response to their own nestlings with artificially reddened gapes. Robins, dunnocks and reed warblers allocated no more food to red-mouthed nestlings than to control nestlings in the same nest, and manipulations of the gape colour of whole broods of reed warblers revealed no effect on provisioning rates. Our data do not support the hypothesis that there is a universal parental preference for redder gapes in opennesting passerines, or that the bright red gape of nestling cuckoos has evolved to exploit parental preferences in these three hosts. We suggest that although mouth colour has little influence on the allocation of feeds resulting from sibling competition and begging intensity in these species, it may have a role under certain conditions.

Published
1999

98. Arthroscopic rotator cuff repair with and without acromioplasty in the treatment of full-thickness rotator cuff tears: a multicenter, randomized controlled trial.

Author

Macdonald P, McRae S, Leiter J, Mascarenhas R, Lapner P, MacDonald, Peter, McRae, Sheila, Leiter, Jeffrey, Mascarenhas, Randy, and Lapner, Peter

Abstract

Background: The primary objective of this prospective randomized controlled trial was to compare functional and quality-of-life indices and rates of revision surgery in arthroscopic rotator cuff repair with and without acromioplasty.Methods: Eighty-six patients consented and were randomly assigned intraoperatively to one of two study groups, and sixty-eight of them completed the study. The primary outcome was the Western Ontario Rotator Cuff (WORC) index. Secondary outcome measures included the American Shoulder and Elbow Surgeons (ASES) shoulder assessment form and a count of revisions required in each group. Outcome measures were completed preoperatively and at three, six, twelve, eighteen, and twenty-four months after surgery.Results: WORC and ASES scores improved significantly in each group over time (p < 0.001). There were no differences in WORC or ASES scores between the groups that had arthroscopic cuff repair with or without acromioplasty at any time point. There were no differences in scores on the basis of acromion type, nor were any interaction effects identified between group and acromion type. Four participants (9%) in the group that had arthroscopic cuff repair alone, one with a Type-2 and three with a Type-3 acromion, required additional surgery by the twenty-four-month time point. The number of patients who required additional surgery was greater (p = 0.05) in the group that had arthroscopic cuff repair alone than in the group that had arthroscopic cuff repair and acromioplasty.Conclusions: Our findings are consistent with previous research reports in which there was no difference in functional and quality-of-life indices for patients who had rotator cuff repair with or without acromioplasty. The higher reoperation rate was found in the group without acromioplasty. Further study that includes follow-up imaging and patient-reported outcomes over a greater follow-up period is needed. [ABSTRACT FROM AUTHOR]

Published
2011
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