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1. Direct oral anticoagulants or vitamin K antagonists in emergencies: comparison of management in an observational study

Author

Chen, V., Young, L., Merriman, E., Curnow, J., Gallus, A., Boey, J., Tan, Chee Wee, McRae, S., Hugman, A., Joseph, J., Harper, P., Brighton, T., Royle, G., Crowther, H., Tran, H., Campbell, P., Baker, R., Baker, Ross I., Gilmore, Grace, Chen, Vivien, Young, Laura, Merriman, Eileen, Curnow, Jennifer, Joseph, Joanne, Tiao, Jim Y., Chih, Jun, McRae, Simon, Harper, Paul, Tan, Chee W., Brighton, Timothy, Royle, Gordon, Hugman, Amanda, Hankey, Graeme J., Crowther, Helen, Boey, Jirping, Gallus, Alexander, Campbell, Philip, and Tran, Huyen

Published
2023
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2. Supracondylar Fractures: A Retrospective Chart Review Comparing Infection Rate, Antibiotic Use, Surgical Time and Cost of Full Surgical Preparation and Draping vs “Semi-Sterile” Technique

Author

Laxdal I, Stockwell K, Xu M, Tan J, McRae S, and Jellicoe P

Subjects
supracondylar, fracture, infections, pediatric, trauma, cost, Orthopedic surgery, RD701-811, Diseases of the musculoskeletal system, RC925-935
Abstract

Ian Laxdal,1 Kevin Stockwell,1 Mark Xu,1 Jonathan Tan,1 Sheila McRae,1,2 Paul Jellicoe1 1Department of Orthopedic Surgery, University of Manitoba, Winnipeg, MB, Canada; 2Pan Am Clinic Foundation, Winnipeg, MB, CanadaCorrespondence: Ian LaxdalDepartment of Orthopedic Surgery, University of Manitoba, AD4 – 820 Sherbrook Street, Winnipeg, MB R3A 1R9, CanadaEmail umlaxdai@myumanitoba.caBackground: Semi-sterile and full preparation and draping techniques are commonly used in closed reduction percutaneous pinning (CRPP) of supracondylar fractures. Debate exists whether full preparation and draping is safer than semi-sterile technique in regards to infection risk and the utility of pre-operative antibiotics. This study is a comparison of infection rates, pre-operative antibiotic administration, cost and surgical time between techniques.Methods: A retrospective chart review of 336 pediatric patients with supracondylar fractures repaired with CRPP at our institution was completed between January 2014 and April 2018, 168 per technique. Infection rates, pre-operative antibiotic administration, preparation-to-incision time and cost in semi-sterile draping versus full preparation and draping techniques were compared.Results: Of the 336 patients, 1/168 (0.1%) in the full preparation and draping group developed an infection compared to 0/168 (0%) patients in the semi-sterile group. Pre-operative antibiotics (Cefazolin) were administered to 76/168 (23%) patients in the full preparation and draping group and 0/168 (0%) in the semi-sterile group. The infection found received pre-operative antibiotics. Mean preparation-to-incision time for the semi-sterile group was 2.4± 2.0 minutes and the full preparation and draping group was 9.9 ± 4.2 minutes (p < 0.001). Surgical supply cost was $80.72 [CDN] and 108.24$ [CDN], respectively, for the semi-sterile and full preparation and draping groups.Conclusion: Risk of infection using a semi-sterile draping technique was safe and comparable to a full preparation and draping technique when used in CRPP of supracondylar fractures. The administration of pre-operative antibiotics does not appear to make a difference in infection rates. Semi-sterile operative technique is cost effective and has decreased preparation-to-incision time.Keywords: supracondylar, fracture, infections, pediatric, trauma, cost

Published
2020

3. Direct oral anticoagulants or Vitamin K antagonists in emergencies: comparison of management in an observational study.

Author

Baker, R.I., primary, Gilmore, G., additional, Chen, V., additional, Young, L., additional, Merriman, E., additional, Curnow, J., additional, Joseph, J., additional, Tiao, J.Y., additional, Chih, J., additional, McRae, S., additional, Harper, P., additional, Tan, C.W., additional, Brighton, T., additional, Royle, G., additional, Hugman, A., additional, Hankey, G., additional, Crowther, H., additional, Boey, J., additional, Gallus, A., additional, Campbell, P., additional, Tran, H., additional, Tan, Chee Wee, additional, and Baker, R., additional

Published
2023
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4. Inhibitor development and mortality in non‐severe hemophilia A

Author

Eckhardt, C.L., Loomans, J.I., van Velzen, A.S., Peters, M., Mauser‐Bunschoten, E.P., Schwaab, R., Mazzucconi, M.G., Tagliaferri, A., Siegmund, B., Reitter‐Pfoertner, S.E., van der Bom, J.G., Fijnvandraat, K., Kamphuisen, P.W., Peerlinck, K., Oldenburg, J., Santagostino, E., Astermark, J., Eckhardt, C.L, van Velzen, A.S, Streefkerk, N., Loomans, J.L., van Eijkelenburg, A., Jansen, A.J., Kruijt, C.C., van Tienoven, B., van Baar, A.C.G., Corten, I.W., Meijer, K., Nijziel, M.R., Dors, N., Hamulyak, K., Beckers, E., Brons, P.P., Laros‐van Gorkom, B.A.P., van Heerde, W.L., Leebeek, F., Kruip, M., Cnossen, M.H., Mauser‐Bunschoten, E., Fischer, K., Smiers, F.J., Hermans, C., Klamroth, R., Escuriola‐Ettingshausen, C., Königs, C., Petrini, P., Holmström, M., Mäkipernaa, A., Male, C., Pabinger, I., Keenan, R.D., Liesner, R., Khair, K., Yee, T.T., Hart, D.P., Rangarajan, S., Mitchell, M., Thompson, G., Haya, S., Moret, A., Cid, A.R., Jimenez‐Yuste, V., Mancuso, M.E., Mazzuconni, M.G., Santoro, C., Morfini, M., Castaman, G., Schinco, P., Rivolta, G.F., Platokouki, H., and McRae, S.

Published
2015
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11. von Willebrand disease: proposing definitions for future research

Author

Connell, N.T., James, P.D., Brignardello-Petersen, R., Abdul-Kadir, R., Ameer, B., Arapshian, A., Couper, S., Paola, J. di, Eikenboom, J., Giraud, N., Grow, J.M., Haberichter, S., Jacobs-Pratt, V., Konkle, B.A., Kouides, P., Laffan, M., Lavin, M., Leebeek, F.W.G., McLintock, C., McRae, S., Montgomery, R., O'Brien, S.H., O'Donnell, J.S., Ozelo, M.C., Scappe, N., Sidonio, R., Tosetto, A., Weyand, A.C., Kalot, M.A., Husainat, N., Mustafa, R.A., Flood, V.H., and Hematology

Subjects
von Willebrand Diseases, von Willebrand Factor, Commentary, Humans
Published
2021

12. Two Weeks of Low Molecular Weight Heparin for Isolated Symptomatic Distal Vein Thrombosis (TWISTER study).

Author

Merriman E., Chunilal S., Brighton T., Chen V., McRae S., Ockelford P., Curnow J., Chong B., Smith M., Royle G., Crowther H., Slocombe A., Tran H., Merriman E., Chunilal S., Brighton T., Chen V., McRae S., Ockelford P., Curnow J., Chong B., Smith M., Royle G., Crowther H., Slocombe A., and Tran H.

Abstract

Background: Treatment of low-risk patients with isolated symptomatic distal deep vein thrombi (IDDVT) is uncertain. Objective(s): assess whether two weeks of therapeutic anticoagulation is efficacious/safe for IDDVT. Primary Outcome: symptomatic three-month venous thromboembolism (VTE) incidence in the two-week anticoagulation group. Secondary outcomes included post-thrombotic syndrome (PTS) and bleeding. Method(s): Prospective multicentre cohort study. Consecutive low-risk IDDVT patients enrolled within 72 h of diagnosis and treated with therapeutic dose enoxaparin or rivaroxaban. At two weeks, patients had repeat complete whole leg compression ultrasound (CUS)/clinical review. If resolution of leg symptoms AND no radiological evidence of thrombus extension, anticoagulation was stopped. If ongoing symptoms and/or radiographic extension within distal veins, anticoagulation was continued for four more weeks. Patients with extension into the popliteal vein on two-week ultrasound were treated off-study. Patients were reviewed at three and six months. Findings/interpretation: 241 eligible patients received >=2 weeks anticoagulation. 167/241 (69%) were assigned to the 2-week anticoagulation group; 71/241 (30%) to the six-week anticoagulation group; 3/241 patients (1%) had extension into the popliteal vein on two-week CUS. Two patients in the two-week anticoagulation group had symptomatic IDDVT recurrence in <=3 months; VTE recurrence 2/156; 1.3%(95% CI 0.05-4.85%). 69% of patients had complete resolution of symptoms within two weeks. Six-month PTS rates were 8/184, 4.4%(95% CI 2.1-8.5%). No major bleeding was reported. Our findings suggest it's safe/efficacious to stop therapeutic anticoagulation at two weeks in low-risk IDDVT patients with resolution of symptoms/no extension on ultrasound. This could replace 6-12 weeks of anticoagulation for ambulatory, low-risk IDDVT patients. Trial registration: ClinicalTrials.gov NCT01252420Copyright © 2021

Published
2021

14. Cancer associated thrombosis in everyday practice: perspectives from GARFIELD-VTE

Author

Weitz, J.I., Haas, S., Ageno, W., Goldhaber, S.Z., Turpie, A.G.G., Goto, S., Angchaisuksiri, P., Nielsen, J.D., Kayani, G., Farjat, A.E., Schellong, S., Bounameaux, H., Mantovani, L.G., Prandoni, P., Kakkar, A.K., Loualidi, A., Colak, A., Bezuidenhout, A., Abdool-Carrim, A., Azeddine, A., Beyers, A., Dees, A., Mohamed, A., Aksoy, A., Abiko, A., Watanabe, A., Krichell, A., Fernandez, A.A., Tosetto, A., Khotuntsov, A., Oropallo, A., Slocombe, A., Kelly, A., Clark, A., Gad, A., Arouni, A., Schmidt, A., Berni, A., Kleiban, A.J., Machowski, A., Kazakov, A., Galvez, A., Lockman, A., Falanga, A., Chauhan, A., Riera-Mestre, A., Mazzone, A., D'Angelo, A., Herdy, A., Kato, A., Salem, A.A.E.E.M., Husin, A., Erdelyi, B., Jacobson, B., Amann-Vesti, B., Battaloglu, B., Wilson, B., Cosmi, B., Francois, B.J., Toufek, B., Hunt, B., Natha, B., Mustafa, B., Kho, B.C.S., Carine, B., Zidel, B., Dominique, B., Christophe, B., Trimarco, B., Luo, C., Cuneo, C.A., Diaz, C.J.S., Schwencke, C., Cader, C., Yavuz, C., Zaidman, C.J., Lunn, C., C. -C., W., Toh, C.H., Chiang, C.-., Elisa, C., Hsia, C.-., Huang, C.-., Kwok, C.-.K., Ward, C., Opitz, C., Jeanneret-Gris, C., C. Y., H., Bidi, C.L., Smith, C., Brauer, C., Lodigiani, C., Francis, C., Wu, C., Staub, D., Theodoro, D., Poli, D., Acevedo, D.-., Adler, D., Jimenez, D., Keeling, D., Scott, D., Imberti, D., Creagh, D., Helene, D.-., Hagemann, D., Le Roux, D., Skowasch, D., Belenky, D., Dorokhov, D., Petrov, D., Zateyshchikov, D., Prisco, D., Moller, D., Kucera, D., Esheiba, E.M., Panchenko, E., Dominique, E., Dogan, E., Kubat, E., Diaz, E.D., Tse, E.W.C., Yeo, E., Hashas, E., Grochenig, E., Tiraferri, E., Blessing, E., Michele, E.O., Usandizaga, E., Porreca, E., Ferroni, F., Nicolas, F., Ayala-Paredes, F., Koura, F., Henry, F., Cosmi, F., Erdkamp, F., Kamalov, G., Dalmau, G.-., Damien, G., Klein, G., Shah, G., Hollanders, G., Merli, G., Plassmann, G., Platt, G., Poirier, G., Sokurenko, G., Haddad, G., Ali, G., Agnelli, G., Gan, G.G., Kaye-Eddie, G., Le Gal, G., Allen, G., Esperon, G.A.L., Jean-Paul, G., Gerofke, H., Elali, H., Burianova, H., Ohler, H.-., Wang, H., Darius, H., Gogia, H.S., Striekwold, H., Gibbs, H., Hasanoglu, H., Turker, H., Franow, H., De Raedt, H., Schroe, H., Eldin, H.S., Zidan, H., Nakamura, H., Kim, H.Y., Lawall, H., Zhu, H., Tian, H., Yhim, H.-., Cate, H., Hwang, H.G., Shim, H., Kim, I., Libov, I., Sonkin, I., Suchkov, I., Song, I.-., Kiris, I., Staroverov, I., Looi, I., De La Azuela Tenorio, I.M., Savas, I., Gordeev, I., Podpera, I., Lee, J.H., Sathar, J., Welker, J., Beyer-Westendorf, J., Kvasnicka, J., Vanwelden, J., Kim, J.Y., Svobodova, J., Gujral, J., Marino, J., Galvar, J.T., Kassis, J., Kuo, J.-., Shih, J.-., Kwon, J.H., Joh, J.H., Park, J.H., Kim, J.S., Yang, J., Krupicka, J., Lastuvka, J., Pumprla, J., Vesely, J., Souto, J.C., Correa, J.A., Duchateau, J., Fletcher, J.P., del Toro, J., Paez, J.G.C., Nielsen, J., Filho, J.D.A., Saraiva, J., Peromingo, J.A.D., Lara, J.G., Fedele, J.L., Surinach, J.M., Chacko, J., Muntaner, J.A., Benitez, J.C.A., Abril, J.M.H., Humphrey, J., Bono, J., Kanda, J., Boondumrongsagoon, J., Yiu, K.H., Chansung, K., Boomars, K., Burbury, K., Kondo, K., Karaarslan, K., Takeuchi, K., Kroeger, K., Zrazhevskiy, K., Svatopluk, K., Shyu, K.-., Vandenbosch, K., Chang, K.-., Chiu, K.-., Jean-Manuel, K., Wern, K.J., Ueng, K.-., Norasetthada, L., Binet, L., Chew, L.P., Zhang, L., Cristina, L.M., Tick, L., Schiavi, L.B., Wong, L.L.L., Borges, L., Botha, L., Capiau, L., Timmermans, L., Lopez, L.E., Ria, L., Blasco, L.M., Guzman, L.A., Cervera, L.F., Isabelle, M., Bosch, M.M., de los Rios Ibarra, M., Fernandez, M.N., Carrier, M., Barrionuevo, M.R., Gamba, M.A.A., Cattaneo, M., Moia, M., Bowers, M., Chetanachan, M., Berli, M.A., Fixley, M., Faghih, M., Stuecker, M., Schul, M., Banyai, M., Koretzky, M., Myriam, M., Gaffney, M.E., Hirano, M., Kanemoto, M., Nakamura, M., Tahar, M., Emmanuel, M., Kovacs, M., Leahy, M., Levy, M., Munch, M., Olsen, M., De Pauw, M., Gustin, M., Van Betsbrugge, M., Boyarkin, M., Homza, M., Koto, M., Abdool-Gaffar, M., Nagib, M.A.F., Dessoki, M.E., Khan, M., Mohamed, M., Kim, M.H., Lee, M.-., Soliman, M., Ahmed, M.S., Bary, M.S.A., Moustafa, M.A., Hameed, M., Kanko, M., Majumder, M., Zubareva, N., Mumoli, N., Abdullah, N.A.N., Makruasi, N., Paruk, N., Kanitsap, N., Duda, N., Nordin, N., Nyvad, O., Barbarash, O., Gurbuz, O., Vilamajo, O.G., Flores, O.N., Gur, O., Oto, O., Marchena, P.J., Carroll, P., Lang, P., Maccallum, P., von Bilderling, P.B., Blombery, P., Verhamme, P., Jansky, P., Bernadette, P., De Vleeschauwer, P., Hainaut, P., Ferrini, P.M., Iamsai, P., Christian, P., Viboonjuntra, P., Rojnuckarin, P., Ho, P., Mutirangura, P., Wells, R., Martinez, R., Miranda, R.T., Kroening, R., Ratsela, R., Reyes, R.L., de Leon, R.F.D., Wong, R.S.M., Alikhan, R., Jerwan-Keim, R., Otero, R., Murena-Schmidt, R., Canevascini, R., Ferkl, R., White, R., Van Herreweghe, R., Santoro, R., Klamroth, R., Mendes, R., Prosecky, R., Cappelli, R., Spacek, R., Singh, R., Griffin, S., S. H., N., Chunilal, S., Middeldorp, S., Nakazawa, S., Toh, S.G., Christophe, S., Isbir, S., Raymundo, S., Ting, S.K., Motte, S., Aktogu, S.O., Donders, S., Cha, S.I., Nam, S.-., Marie-Antoinette, S.-., Maasdorp, S., Sun, S., Wang, S., Essameldin, S.M., Sholkamy, S.M., Kuki, S., Yoshida, S., Matsuoka, S., Mcrae, S., Watt, S., Patanasing, S., Jean-Leopold, S.-., Wongkhantee, S., Bang, S.-., Testa, S., Zemek, S., Behrens, S., Dominique, S., Mellor, S., Singh, S.S.G., Datta, S., Chayangsu, S., Solymoss, S., Everington, T., Abdel-Azim, T.A.A., Suwanban, T., Adademir, T., Hart, T., Beatrice, T., Luvhengo, T., Horacek, T., Zeller, T., Boussy, T., Reynolds, T., Biss, T., Chao, T.-., Casabella, T.S., Onodera, T., Numbenjapon, T., Gerdes, V., Cech, V., Krasavin, V., Tolstikhin, V., Bax, W.A., Malek, W.F.A., W. K., H., Pharr, W., Jiang, W., Lin, W.-., Zhang, W., Tseng, W.-., Lai, W.-., De Backer, W., Haverkamp, W., Yoshida, W., Korte, W., Choi, W., Kim, Y.-., Tanabe, Y., Ohnuma, Y., Mun, Y.-., Balthazar, Y., Park, Y., Shibata, Y., Burov, Y., Subbotin, Y., Coufal, Z., Yang, Z., Jing, Z., Pulmonary Medicine, Clinical Genetics, Internal Medicine, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, ARD - Amsterdam Reproduction and Development, ACS - Diabetes & metabolism, Weitz, J, Haas, S, Ageno, W, Goldhaber, S, Turpie, A, Goto, S, Angchaisuksiri, P, Nielsen, J, Kayani, G, Farjat, A, Schellong, S, Bounameaux, H, Mantovani, L, Prandoni, P, Kakkar, A, GARFIELD-VTE, I, Falanga, A, MUMC+: HVC Trombosezorg (8), RS: Carim - B04 Clinical thrombosis and Haemostasis, MUMC+: HVC Pieken Trombose (9), MUMC+: MA Alg Interne Geneeskunde (9), Interne Geneeskunde, and Biochemie

Subjects
Male, Time Factors, Settore MED/09 - Medicina Interna, 030204 cardiovascular system & hematology, PROPHYLAXIS, 0302 clinical medicine, Recurrence, Risk Factors, Cause of Death, Neoplasms, Prospective Studies, Registries, 030212 general & internal medicine, DEEP-VEIN THROMBOSIS, Cancer, Aged, 80 and over, Venous Thrombosis, Hematology, Incidence (epidemiology), Anticoagulant, Hazard ratio, Middle Aged, Treatment Outcome, Female, CLINICAL-PRACTICE GUIDELINES, Cardiology and Cardiovascular Medicine, Venous thromboembolism, Adult, medicine.medical_specialty, Registry, medicine.drug_class, Hemorrhage, Malignancy, Anticoagulation, Risk Assessment, 03 medical and health sciences, Fibrinolytic Agents, SDG 3 - Good Health and Well-being, Internal medicine, medicine, MANAGEMENT, Humans, cardiovascular diseases, Aged, business.industry, Anticoagulants, medicine.disease, Confidence interval, RISK-FACTORS, Observational study, Pulmonary Embolism, business
Abstract

Venous thromboembolism (VTE) is common in cancer patients and is an important cause of morbidity and mortality. The Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE (ClinicalTrials.gov: NCT02155491) is a prospective, observational study of 10,684 patients with objectively diagnosed VTE from 415 sites in 28 countries. We compared baseline characteristics, VTE treatment patterns, and 1-year outcomes (mortality, recurrent VTE and major bleeding) in 1075 patients with active cancer, 674 patients with a history of cancer, and 8935 patients without cancer. Patients with active cancer and history of cancer were older than cancer-free patients, with median ages of 64.8, 68.9, and 58.4 years, respectively. The most common sites of active cancer were lung (14.5%), colorectal (11.0%), breast (10.6%), and gynaecological (10.3%). Active cancer patients had a higher incidence of upper limb and vena cava thrombosis than cancer-free patients (9.0% vs 4.8% and 5.1% vs 1.4%, respectively), and were more likely to receive parenteral anticoagulation as monotherapy than cancer-free patients (57.8% vs 12.1%), and less likely to receive DOACs (14.2% vs 50.6%). Rates of death, recurrent VTE, and major bleeding were higher in active cancer patients than in cancer-free patients, with hazard ratios (95% confidence intervals) of 14.2 (12.1-16.6), 1.6 (1.2-2.0) and 3.8 (2.9-5.0), respectively. VTE was the second most common cause of death in patients with active cancer or history of cancer. In patients with VTE, those with active cancer are at higher risk of death, recurrence, and major bleeding than those without cancer.

Published
2020

15. Product type and the risk of inhibitor development in nonsevere haemophilia A patients

Author

Velzen, A.S. van, Eckhardt, C.L., Peters, M., Oldenburg, J., Cnossen, M., Liesner, R., Morfini, M., Castaman, G., McRae, S., Bom, J.G. van der, Fijnvandraat, K., INSIGHT Consortium, General Paediatrics, ACS - Amsterdam Cardiovascular Sciences, Paediatric Haematology, ACS - Pulmonary hypertension & thrombosis, ARD - Amsterdam Reproduction and Development, and Pediatrics

Subjects
Adult, Male, medicine.medical_specialty, congenital, hereditary, and neonatal diseases and abnormalities, Adolescent, animal diseases, Haemophilia A, haemophilia, Hemophilia A, Haemophilia, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, hemic and lymphatic diseases, Humans, Medicine, antibodies, risk factors, Major complication, Date of birth, Child, Retrospective Studies, Blood Coagulation Factor Inhibitors, business.industry, Platelets, Haemostasis and Thrombosis, Case-control study, Hematology, Odds ratio, Middle Aged, medicine.disease, Confidence interval, Increased risk, factor VIII, Child, Preschool, 030220 oncology & carcinogenesis, business, Research Paper, 030215 immunology
Abstract

Inhibitor development is a major complication of treatment with factor VIII concentrates in nonsevere haemophilia A. It has been suggested that plasma-derived factor VIII (FVIII) concentrates elicit fewer inhibitors than recombinant FVIII concentrates, but studies in severe haemophilia A patients have shown conflicting results. We designed a case-control study to investigate the clinical and genetic risk factors for inhibitor development in nonsevere haemophilia A patients. We investigated whether the type of FVIII concentrate was associated with inhibitor development in nonsevere haemophilia A patients. This nested case-control study includes 75 inhibitor patients and 223 controls, from a source population of the INSIGHT study, including all nonsevere haemophilia A patients (FVIII:C 2-40%) that were treated with FVIII concentrates in 33 European and one Australian centre. Cases and controls were matched for date of birth and cumulative number of exposure days (CED) to FVIII concentrate. A conditional logistic regression model was used to calculate unadjusted and adjusted odds ratios. No increased risk for inhibitor development was found for any type of FVIII concentrate; either when comparing recombinant FVIII concentrates to plasma-derived FVIII concentrates (adjusted odds ratio 0 center dot 96, 95% confidence interval (CI) 0 center dot 36-2 center dot 52) or for specific types of FVIII concentrates.

Published
2020

16. The burden of immune-mediated refractoriness to platelet transfusions in myelodysplastic syndromes.

Author

Wood E.M., McRae S., Bardy P., Singhal D., Roxby D.J., Hiwase D.K., Cheok K.P.L., Chhetri R., Wee L.Y.A., Friel O., Pham A., Salvi A., Wood E.M., McRae S., Bardy P., Singhal D., Roxby D.J., Hiwase D.K., Cheok K.P.L., Chhetri R., Wee L.Y.A., Friel O., Pham A., and Salvi A.

Abstract

Up to 65% of patients with myelodysplastic syndromes (MDS) have thrombocytopenia and require platelet (PLT) transfusion. The current standard of practice is to provide random- or single-donor PLT transfusion and manage PLT refractoriness (PLT-R) if and when it develops. This study assessed the prevalence and risk factors for immune-mediated PLT-R in patients in the South Australian (SA) MDS Registry. Study Design and Methods: A retrospective analysis of MDS patients enrolled in the SA-MDS registry was performed. HLA data was analyzed from January 2003 to 30 June 2017 to ensure minimum follow-up of 2 years. Result(s): During the study period, 341 of 681 (50%) MDS patients required at least one PLT transfusion, with 29 of 341 (9%) of all PLT transfusion patients requiring HLA-matched PLT transfusion for PLT-R. Of these 29 patients, 70% were females treated with disease-modifying therapies suggesting that these patients are at high risk of HLA alloimmunization. Conclusion(s): Immune-mediated PLT-R is common in MDS and can be expensive and difficult to manage once it occurs. Therefore, PLT transfusion practices should be optimized, especially for female MDS patients planned for disease-modifying therapies. This can help save time and streamline management, especially in the provision of PLT products for these patients, where the consequences of alloimmunization and PLT-R can be severe.Copyright © 2020 AABB

Published
2020

17. Two weeks of low molecular weight heparin for isolated symptomatic distal vein thrombosis (Twister Study): Final analysis of 242 patients.

Author

Chen V., Tran H., Cummins A., Slocombe A., Crowther H., Royle G., Smith M., Merriman E., Chunilal S., McRae S., Brighton T., Ockelford P., Curnow J., Chong B., Chen V., Tran H., Cummins A., Slocombe A., Crowther H., Royle G., Smith M., Merriman E., Chunilal S., McRae S., Brighton T., Ockelford P., Curnow J., and Chong B.

Abstract

Background: Most deep vein thromboses (DVT) originate from distal (calf) vein thrombi, however 80-90% of these lyse spontaneously. The management of isolated distal DVT(IDDVT) is controversial. Aim(s): Examine the efficacy/safety of two weeks of anticoagulation for a first symptomatic IDDVT. Method(s): Multicentre prospective cohort study in Australia/New Zealand for patients with confirmed first symptomatic IDDVT. Exclusions included active malignancy, bleeding risk factors, pregnancy/ lactation, immobility, plaster casts or non-weight-bearing. Patients received therapeutic anticoagulation (enoxaparin or rivaroxaban) with repeat complete compression leg vein ultrasound (CUS) at the end of 2 weeks. Those with extension into proximal veins on two-week CUS were treated off study (group A). For those with ongoing symptoms, treatment was continued for a further 4 weeks (group B). If the patient was asymptomatic and there was no proximal DVT extension on CUS, treatment was stopped (group C). The primary outcome was the symptomatic recurrence of venous thromboembolism, VTE (DVT and pulmonary embolism, PE) within 3 months, in group C patients. Result(s): 242 patients were enrolled at twelve sites; one was withdrawn on day five due to clinically relevant non-major bleeding. Of the remaining 241, 167(69%) received two weeks anticoagulation; 71(30%) six weeks anticoagulation; and three patients(1%) had proximal extension on 2-week CUS. Eleven patients in group C were lost to follow-up. Of the remaining 156 in the two-week anticoagulation arm, two had symptomatic distal DVT recurrence; VTE recurrence rate 2/156; 1.3%(95% CI 0.19-5.41%). No patients, 0/156; 0%(95% CI 0.00-2.34) had proximal DVT or PE recurrence. Conclusion(s): For IDDVT patients, two weeks of anticoagulation is associated with a low risk of VTE recurrence (1.3%), if patients are symptom-free at two weeks and repeat CUS at two weeks does not show thrombus extension into proximal veins. Based on this data, the pr

Published
2020

18. Product type and the risk of inhibitor development in nonsevere haemophilia A patients: a case‒control study

Author

Velzen, A.S. (Alice) van, Eckhardt, C.L. (Corien L.), Peters, M.A.D. (Marjolein), Oldenburg, J., Cnossen, M.H. (Marjon), Liesner, R. (Ri), Morfini, M. (Massimo), Castaman, G. (Giancarlo), McRae, S., Bom, J.G. (Anske) van der, Fijnvandraat, K., Velzen, A.S. (Alice) van, Eckhardt, C.L. (Corien L.), Peters, M.A.D. (Marjolein), Oldenburg, J., Cnossen, M.H. (Marjon), Liesner, R. (Ri), Morfini, M. (Massimo), Castaman, G. (Giancarlo), McRae, S., Bom, J.G. (Anske) van der, and Fijnvandraat, K.

Abstract

Inhibitor development is a major complication of treatment with factor VIII concentrates in nonsevere haemophilia A. It has been suggested that plasma-derived factor VIII (FVIII) concentrates elicit fewer inhibitors than recombinant FVIII concentrates, but studies in severe haemophilia A patients have shown conflicting results. We designed a case‒control study to investigate the clinical and genetic risk factors for inhibitor development in nonsevere haemophilia A patients. We investigated whether the type of FVIII concentrate was associated with inhibitor development in nonsevere haemophilia A patients. This nested case‒control study includes 75 inhibitor patients and 223 controls, from a source population of the INSIGHT study, including all nonsevere haemophilia A patients (FVIII:C 2–40%) that were treated with FVIII concentrates in 33 European and one Australian centre. Cases and controls were matched for date of birth and cumulative number of exposure days (CED) to FVIII concentrate. A conditional logistic regression model was used to calculate unadjusted and adjusted odds ratios. No increased risk for inhibitor development was found for any type of FVIII concentrate; either when comparing recombinant FVIII concentrates to plasma-derived FVIII concentrates (adjusted odds ratio 0·96, 95% confidence interval (CI) 0·36–2·52) or for specific types of FVIII concentrates.

Published
2020
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29. Two weeks of low molecular weight heparin for isolated symptomatic distal vein thrombosis (TWISTER Study): Interim analysis of first 200 patients.

Author

Crowther H., Royle G., Slocombe A., Tran H., Cummins A., Merriman E., Chunilal S., McRae S., Brighton T., Ockelford P., Curnow J., Chen V., Chong B., Smith M., Crowther H., Royle G., Slocombe A., Tran H., Cummins A., Merriman E., Chunilal S., McRae S., Brighton T., Ockelford P., Curnow J., Chen V., Chong B., and Smith M.

Abstract

Background : Most deep vein thrombosis (DVT) originate from distal (calf) vein thrombi, however 80- 90% of these lyse spontaneously. The management of isolated distal DVT (IDDVT) is controversial. Aims : Examine the efficacy and safety of two weeks of anticoagulation for a first symptomatic IDDVT. Methods : Multicentre prospective cohort study in Australia/New Zealand for patients with confirmed first symptomatic IDDVT. Exclusions included active malignancy, bleeding risk factors, pregnancy/ lactation, ongoing immobility, plaster casts or non- weightbearing. Patients received 2 weeks of therapeutic anticoagulation (enoxaparin or rivaroxaban) with repeat complete compression leg vein ultrasound (CUS) at the end of 2 weeks. If the patient was asymptomatic and there was no proximal DVT extension on CUS, treatment was stopped (group A). If the patient was still symptomatic, treatment was continued for a further 4 weeks(group B). The primary outcome is symptomatic recurrence of venous thromboembolism, VTE (DVT and pulmonary embolism, PE) within 3 months, in group A patients. Results : 200 patients were enrolled at eleven sites; one was withdrawn on day five due to clinically relevant non- major bleeding. Of the remaining 199, 140 (70%) received two weeks anticoagulation; 56 (28%) six weeks anticoagulation; and three patients (2%) had proximal extension on 2- week CUS. Nine patients in group A were lost to follow- up. Of the remaining 131 in the two- week anticoagulation arm, three had symptomatic distal DVT recurrence - VTE recurrence rate 3/131; 2.3%(95% CI 0.77- 5.07%). No patients, 0/131; 0%(95% CI 0.00- 2.78) had proximal DVT or PE recurrence. Conclusions : For patients with IDDVT, two weeks of anticoagulation is associated with a low risk of VTE recurrence (2.3%), if patients are symptom- free at two weeks and the repeat CUS at two weeks doesn ' t show thrombus extension into proximal veins. Based on this data, the previous standard of care, 6- 12 weeks anticoagulat

Published
2019

33. Haemoglobin concentration and volume of intravenous fluids in septic shock in the ARISE trial.

Author

Peake S., Bellomo R., Bailey M., Delaney A., McRae S., Maiden M.J., Finnis M.E., Peake S., Bellomo R., Bailey M., Delaney A., McRae S., Maiden M.J., and Finnis M.E.

Abstract

Background: Intravenous fluids may contribute to lower haemoglobin levels in patients with septic shock. We sought to determine the relationship between the changes in haemoglobin concentration and the volume of intravenous fluids administered during resuscitation from septic shock. Method(s): We performed a retrospective cohort study of patients enrolled in the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial who were not transfused red blood cells (N = 1275). We determined the relationship between haemoglobin concentration, its change over time and volume of intravenous fluids administered over 6, 24 and 72 h using univariate and multivariate analysis. Result(s): Median (IQR) haemoglobin concentration at baseline was 133 (118-146) g/L and decreased to 115 (102-127) g/L within the first 6 h of resuscitation (P < 0.001), 110 (99-122) g/L after 24 h, and 109 (97-121) g/L after 72 h. At the corresponding time points, the cumulative volume of intravenous fluid administered was 1.3 (0.7-2.2) L, 2.9 (1.8-4.3) L and 4.6 (2.7-7.1) L. Haemoglobin concentration and its change from baseline had an independent but weak association with intravenous fluid volume at each time point (R 2 < 20%, P < 0.001). After adjusting for covariates, each litre of intravenous fluid administered was associated with a change in haemoglobin concentration of - 1.0 g/L (95% CI -1.5 to -0.6, P < 0.001) at 24 h and - 1.3 g/L (-1.6 to - 0.9, P < 0.001) at 72 h. Conclusion(s): Haemoglobin concentration decreases during resuscitation from septic shock, and has a significant but weak association with the volume of intravenous fluids administered.Copyright © 2018 The Author(s).

Published
2018

34. Haemoglobin concentration and volume of intravenous fluids in septic shock in the ARISE trial

Author

Maiden, MJ, Finnis, ME, Peake, S, McRae, S, Delaney, A, Bailey, M, Bellomo, R, Maiden, MJ, Finnis, ME, Peake, S, McRae, S, Delaney, A, Bailey, M, and Bellomo, R

Abstract

BACKGROUND: Intravenous fluids may contribute to lower haemoglobin levels in patients with septic shock. We sought to determine the relationship between the changes in haemoglobin concentration and the volume of intravenous fluids administered during resuscitation from septic shock. METHODS: We performed a retrospective cohort study of patients enrolled in the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial who were not transfused red blood cells (N = 1275). We determined the relationship between haemoglobin concentration, its change over time and volume of intravenous fluids administered over 6, 24 and 72 h using univariate and multivariate analysis. RESULTS: Median (IQR) haemoglobin concentration at baseline was 133 (118-146) g/L and decreased to 115 (102-127) g/L within the first 6 h of resuscitation (P < 0.001), 110 (99-122) g/L after 24 h, and 109 (97-121) g/L after 72 h. At the corresponding time points, the cumulative volume of intravenous fluid administered was 1.3 (0.7-2.2) L, 2.9 (1.8-4.3) L and 4.6 (2.7-7.1) L. Haemoglobin concentration and its change from baseline had an independent but weak association with intravenous fluid volume at each time point (R2 < 20%, P < 0.001). After adjusting for covariates, each litre of intravenous fluid administered was associated with a change in haemoglobin concentration of - 1.0 g/L (95% CI -1.5 to -0.6, P < 0.001) at 24 h and - 1.3 g/L (- 1.6 to - 0.9, P < 0.001) at 72 h. CONCLUSIONS: Haemoglobin concentration decreases during resuscitation from septic shock, and has a significant but weak association with the volume of intravenous fluids administered.

Published
2018

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

Author

Eckhardt, C.L., Velzen, A.S. van, Peters, M., Astermark, J., Brons, P.P., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Hay, C.R.M., Haya, S., Heerde, W.L. van, Hermans, C., Holmstrom, M., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Gorkom, B.A.P., Leebeek, F.W.G., Liesner, R., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., Mcrae, S., Meijer, K., Mitchell, M., Morfini, M., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Smiers, F.J., Siegmund, B., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., INSIGHT Study Grp, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Centre de malformations vasculaires congénitales, Cardiovascular Centre (CVC), Vascular Ageing Programme (VAP), RS: CARIM School for Cardiovascular Diseases, Biochemie, Interne Geneeskunde, Pediatrics, Hematology, Epidemiology, Other departments, Paediatric Infectious Diseases / Rheumatology / Immunology, ACS - Amsterdam Cardiovascular Sciences, and AII - Amsterdam institute for Infection and Immunity

Subjects
Invasive mycoses and compromised host Translational research [N4i 2], Adult, medicine.medical_specialty, Age-related aspects of cancer [ONCOL 2], Time Factors, Adolescent, Genotype, Immunology, Mutation, Missense, Kaplan-Meier Estimate, Hemophilia A, DIAGNOSIS, Biochemistry, Gastroenterology, Young Adult, Interquartile range, Risk Factors, Internal medicine, medicine, Missense mutation, Humans, Cumulative incidence, Desmopressin, Genotyping, POLYMORPHISMS, Retrospective Studies, Hematology, Factor VIII, Cardiovascular diseases [NCEBP 14], business.industry, Incidence (epidemiology), DESMOPRESSIN, Cell Biology, Middle Aged, MILD, Antibodies, Neutralizing, Confidence interval, Treatment Outcome, business, medicine.drug, Follow-Up Studies
Abstract

Neutralizing antibodies (inhibitors) toward factor VIII form a severe complication in nonsevere hemophilia A, profoundly aggravating the bleeding pattern. Identification of high-risk patients is hampered by lack of data that take exposure days to therapeutic factor VIII concentrates into account. In the INSIGHT study, we analyzed the association between F8 mutation and inhibitor development in patients with nonsevere hemophilia A (factor VIII 2-40 IU/dL). This analysis included 1112 non-severe hemophilia A patients from 14 centers in Europe and Australia that had genotyped at least 70% of their patients. Inhibitor risk was calculated as Kaplan-Meier incidence with cumulative number of exposure days as the time variable. During 44 800 exposure days (median, 24 exposure days per patient; interquartile 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 the risk further increased to 13.3% (95% CI, 9.6-17.0). Among a total of 214 different F8 missense mutations 19 were associated with inhibitor development. These results emphasize the importance of F8 genotyping in nonsevere hemophilia A. ( Blood . 2013; 122(11):1954-1962) © 2013 by The American Society of Hematology.

Published
2013
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41. Land Judging

Author

Burnham, C. P. and McRae, S. G.

Published
1974

42. Efficacy and safety of once weekly subcutaneous idrabiotaparinux in the treatment of patients with symptomatic deep venous thrombosis

Author

Büller, Hr, Destors, Jm, Gallus, A, Prins, Mh, Raskob, G, Charbonnier, B, Decousus, H, Leizorovicz, A, Laporte, S, Brandjes, Dp, Middeldorp, S, Pillion, G, Ceresetto, Jm, Hendler, H, Xavier, Dl, Santini, F, del Carmen Gallo, M, Coughlin, P, Chong, B, Leahy, M, Ward, C, Leyden, M, Prosser, I, Carroll, P, Gan, E, Mcrae, S, Salem, H, Pilger, E, Koppensteiner, R, Jurecka, W, Forstner, K, Hainaut, P, Motte, S, Vermassen, F, Araujo, Gr, Timi, Jr, Costa, Ja, Manenti, F, Yoshida, Wb, Kovacs, M, Delle Siega, A, Rodger, M, Miron, Mj, Anderson, D, Yeo, E, Kassis, J, Spacek, R, Klimsa, Z, Patek, F, Matoska, P, Maly, J, Srnsky, V, Cepelak, C, Nielsen, H, Noelsen, Hk, Avstrom, S, Husted, S, Tuxen, C, Stender, S, Azarian, R, Leftheriotis, G, Jego, P, Achkar, A, Zeltser, D, Keidar, S, Inbal, A, Piovella, F, Barone, M, Prandoni, Paolo, Imberti, D, Palaretti, G, Jerjes, C, Calvo, C, Van Marwijk Kooij, M, Timmerman, R, Mol, J, Ten Cate, H, Kamphuisen, P, Dullemond, A, Kroon, C, Veth, D, Biesma, D, Van Leendert, R, Ockelford, P, Chunilal, S, Szyber, P, Strzelczyk, J, Checinsli, P, Nizankowki, R, Cianciara, J, Kloczko, J, Tomkowski, W, Gutowski, P, Stupin, V, Sokurenko, G, Kirienko, A, Baesukov, A, Sokora, V, Katelnitsky, I, Didenko, Y, Lukianov, Y, Zatevakhin, I, Gavrilenko, A, Van Zyl LJ, Basson, Mm, Becker, Lh, Siebert, S, Engelbrecht, Jm, Otero, Dr, Paloma, Mj, del Toro, H, Kürşat Bozkurt, A, Joseph, S, Nadar, V, Baird, I, Han, D, Jacobson, A, Martin, J, Smith, D, Comerota, A, Guza, E, Wright, P., Epidemiologie, MUMC+: KIO Kemta (9), Interne Geneeskunde, Biochemie, RS: CARIM School for Cardiovascular Diseases, RS: CAPHRI School for Public Health and Primary Care, Amsterdam Cardiovascular Sciences, and Vascular Medicine

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, medicine.drug_mechanism_of_action, Injections, Subcutaneous, Idraparinux, Factor Xa Inhibitor, Biotin, Oligosaccharides, Once weekly, Hemorrhage, Risk Assessment, Gastroenterology, bioequipotency, Drug Administration Schedule, treatment randomized trial, law.invention, auticoagulants, Double-Blind Method, Randomized controlled trial, Recurrence, law, Internal medicine, medicine, Humans, Blood Coagulation, deep venous thrombosis, Aged, Venous Thrombosis, Idrabiotaparinux, business.industry, Incidence (epidemiology), Anticoagulants, Hematology, Middle Aged, medicine.disease, United States, Confidence interval, Europe, Venous thrombosis, Treatment Outcome, Factor Xa, Female, business, Factor Xa Inhibitors
Abstract

Idraparinux, a long acting inhibitor of factor (F) Xa, is as effective as standard anticoagulant therapy for patients with symptomatic deep venous thrombosis. We investigated the potential use of the biotinylated molecule, idrabiotaparinux. Biotinylation enables reversal of the anticoagulant effect.We performed a randomized double-blind trial in 757 patients with symptomatic deep venous thrombosis, comparing equimolar doses of idrabiotaparinux (3 mg) with idraparinux (2.5 mg), both given subcutaneously, once weekly for 6 months. Inhibition of FXa activity was measured at days 15, 36, 57, 92 and 183. The efficacy outcome was recurrent venous thromboembolism. The safety outcomes were clinically relevant bleeding and death.Inhibition of FXa was similar in the two treatment groups at each time point of measurement. Recurrent venous thromboembolism during the 6-month treatment period occurred in nine of 386 patients (2.3%) in the idrabiotaparinux group and in 12 of 371 patients (3.2%) in the idraparinux group, a difference of - 0.9% (95% confidence interval, -3.2-1.4%). The incidence of clinically relevant bleeding was 5.2% in the idrabiotaparinux group and 7.3% in the idraparinux group (P = 0.29), a difference of - 2.1% (95% confidence interval, -5.6-1.4%). Six patients (1.6%) who received idrabiotaparinux died, compared with 12 patients (3.2%) given idraparinux, a difference of - 1.7% (95% confidence interval, -3.9-0.5%).Idrabiotaparinux has a similar time course of FXa inhibition, efficacy and safety to idraparinux for the treatment of deep venous thrombosis.? 2010 International Society on Thrombosis and Haemostasis.

Published
2011
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44. Formulation and solution of hyperbolic Stefan problem.

Author

Glass, David E., Necati Ozisik, M., McRae, S. Scott, and Kim, W. S.

Subjects
HYPERBOLIC geometry, NUMERICAL analysis
Abstract

Presents a study that investigated the formulation and solution of hyperbolic Stefan problem. Formulation; Numerical analysis; Results and discussion.

Published
1991
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46. Prediction of DDAVP response in 850 non-severe hemophilia A patients

Author

Loomans, J.I., Velzen, A.S. van, Eckhardt, C.L., Peters, M., Astermark, J., Brons, P.P., Carcao, M.D., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Haya, S., Heerde, W.L. van, Hermans, C., Holmstrom, M., Jackson, S.C., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Konigs, C., Kruip, M.J.H.A., Laros-Van Gorkom, B.A.P., Leebeek, F.W.G., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., Mcrae, S., Meijer, K., Mitchell, M., Morfini, M., Nance, D., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Rangarajan, S., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., and Rise Study Grp

Published
2014

47. Von Willebrand Factor antigen and age explain variation in baseline FVIII:C among nonsevere hemophilia A patients with the same F8 genotype (Arg593Cys and Asn618Ser)

Author

Loomans, J.I., Velzen, A.S. van, Eckhardt, C.L., Peters, M., Astermark, J., Brons, P.P., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Hay, C.R.M., Haya, S., Heerde, W.L. van, Hermans, C., Holmstroom, M., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Konigs, C., Kruip, M.J.H.A., Laros-Van Gorkom, B.A.P., Leebeek, F.W.G., Liesner, R., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., Mcrae, S., Meijer, K., Mitchell, M., Morfini, M., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Rangarajan, S., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Smiers, F.J., Siegmund, B., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., and Insight Rise Study Grp

Published
2014

48. Clinical presentation of inhibitor development in non-severe hemophilia A: half of patients have high titer inhibitors and present with bleeding complications

Author

Eckhardt, C.L., Loomans, J.I., Velzen, A.S. van, Peters, M., Astermark, J., Brons, P.P., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Hay, C.R.M., Haya, S., Heerde, W.L. van, Hermans, C., Holmstrom, M., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Laros-Gorkom, B.A.P. van, Leebeek, F.W.G., Liesner, R., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., Mcrae, S., Meijer, K., Mitchell, M., Morfini, M., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Rangarajan, S., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Smiers, F.J., Siegmund, B., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., and Insight Study Grp

Published
2014

49. Inhibitors increase the burden of disease in nonsevere haemophilia A patients - treatment strategies to obtain hemostasis

Author

Velzen, A.S. van, Eckhardt, C.L., Streefkerk, N., Peters, M., Astermark, J., Brons, P.P., Castaman, G., Cnossen, M.H., Dors, N., Escuriola-Ettingshausen, C., Hamulyak, K., Hart, D.P., Hay, C.R.M., Haya, S., Heerde, W.L. van, Hermans, C., Holmstrom, M., Jimenez-Yuste, V., Keenan, R.D., Klamroth, R., Gorkom, B.A.P.L. van, Leebeek, F.W.G., Liesner, R., Makipernaa, A., Male, C., Mauser-Bunschoten, E., Mazzucconi, M.G., McRae, S., Meijer, K., Morfini, M., Nijziel, M., Oldenburg, J., Peerlinck, K., Petrini, P., Platokouki, H., Rangarajan, S., Reitter-Pfoertner, S.E., Santagostino, E., Schinco, P., Smiers, F.J., Siegmund, B., Tagliaferri, A., Yee, T.T., Kamphuisen, P.W., Bom, J.G. van der, Fijnvandraat, K., and INSIGHT Study Grp

Published
2014

50. Inhibitors increase the burden of disease in nonsevere haemophilia A patients - treatment strategies to obtain hemostasis

Author

Van Velzen, Alice S., Eckhardt, Corien L., Streefkerk, Nina, Peters, Marjolein, Astermark, Jan, Brons, Paul P., Castaman, Giancarlo, Cnossen, Marjon H., Dors, Natasja, Escuriola-Ettingshausen, Carmen, Hamulyak, Karly, Hart, Daniel P., Hay, Charles R.M., Haya, Saturnino, Van Heerde, Waander L., Hermans, Cedric, Holmström, Margaretha, Imenez-Yuste, Victor J., Keenan, Russell D., Klamroth, Robert, Van gorkom, Britta A.P. Laros, Leebeek, Frank W.G., Iesner, Ril, Mäkipernaa, Anne, Male, Christoph, Mauser-Bunschoten, Eveline, Mazzucconi, Maria G., Imon Mcrae, S, Meijer, Karina, Morfini, Massimo, Nijziel, Marten, Oldenburg, Johannes, Peerlinck, Kathelijne, Petrini, Pia, Platokouki, Helen, Rangarajan, Savita, Reitter-Pfoertner, Sylvia E., Santagostino, Elena, Schinco, P. Iercarla, Smiers, Frans J., Iegmund, Berthold S., Tagliaferri, Annarita, Yee, Thynn T., Kamphuisen, Pieter Willem, Van Der Bom, Johanna G., Fijnvandraat, Karin, Cardiovascular Centre (CVC), and Vascular Ageing Programme (VAP)

Subjects
desmopressin, neutralizing antibody, bleeding, cohort analysis, confidence interval, risk factor, exposure, hemic and lymphatic diseases, hemophilia, hemostasis, hemophilia A, patient, human, protein
Abstract

Introduction and Objectives: Neutralizing antibodies (inhibitors) directed against the FVIII protein may increase the bleeding frequency and compromise the management of bleeding episodes in nonsevere haemophilia A patients. The median annual bleeding frequency in patients without inhibitors is described to be 0 (IQR 0-3) for mild haemophilia and 1 (IQR 0-13) for moderate haemophilia. The aim of this study was to evaluate the burden of bleeding and to describe the treatment strategies that are used for bleeding episodes in a large group of unselected inhibitor patients with nonsevere haemophilia A. Materials and Methods: We included all inhibitor patients from the INSIGHT study, an international multicentre cohort study including all 2709 nonsevere HA patients (FVIII:C 2-4 IU/dL) that received at least 1 exposure to FVIII concentrate between 1980-2011. Data of the 1st inhibitor period were analyzed. Results: We included 107 nonsevere HA inhibitor patients (median baseline FVIII:C 9 IU/dL (IQR 6-16); median age of 38 years (IQR 15-61)). A high titre inhibitor (> 5 BU/mL) was present in 57 (53%) patients. In 30 (28%) patients the FVIII:C level was decreased ≤1 IU/dL. Eighty-nine patients (83%) received treatment for bleeding episodes. Most patients had spontaneous bleeds (n = 49, 46%); a higher proportion of high titre patients had spontaneous bleeds compared to low titre patients (83% vs. 53%, relative risk (RR) 2.7, 95% confidence interval (CI) 1.3-5.8). The median number of bleeding episodes per inhibitor year was 2 (IQR 1-5); this did not differ between patients with FVIII:C ≤ 1 IU/dL and those with measurable FVIII levels (p = 0.5), patients with low titre and high titre inhibitors (p = 0.5) and patients receiving eradication treatment or not (p = 0.7). In order to treat bleedings, FVIII concentrate was used in 59 patients (55%), FVIII bypassing agents in 50 (47%) and desmopressin in 18 patients (17%). Desmopressin was used more often in patients with remaining circulating FVIII:C levels compared to patients with a FVIII:C ≤ 1 IU/dL and in patients without eradication treatment compared to patients with eradication treatment (25% vs. 3%; RR 7.4, CI 1.0-53.5 and 25% vs. 0%; RR 14.0, CI 0.9 - 224.6, respectively). Conclusion: Inhibitor development in nonsevere HA patients aggravates the burden of bleeding with the majority (83%) of the patients needing treatment for bleeding episodes, at a median of 2 bleeding episodes per year.

Published
2014

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