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1. Incidence of thrombotic complications and overall survival in hospitalized patients with COVID-19 in the second and first wave

Author

Kaptein, F.H.J., Stals, M.A.M., Grootenboers, M., Braken, S.J.E., Burggraaf, J.L.I., van Bussel, B.C.T., Cannegieter, S.C., ten Cate, H., Endeman, H., Gommers, D.A.M.P.J., van Guldener, C., de Jonge, E., Juffermans, N.P., Kant, K.M., Kevenaar, M.E., Koster, S., Kroft, L.J.M., Kruip, M.J.H.A., Leentjens, J., Marechal, C., Soei, Y.L., Tjepkema, L., Visser, C., Klok, F.A., and Huisman, M.V.

Published
2021
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2. Lupus anticoagulant associates with thrombosis in patients with COVID-19 admitted to intensive care units

Author

Noordermeer, Tessa, Schutgens, Roger E. G., Visser, Chantal, Rademaker, Emma, de Maat, Moniek P. M., Jansen, A. J. Gerard, Limper, Maarten, Cremer, Olaf L., Kruip, Marieke J. H. A., Endeman, Henrik, Maas, Coen, de Laat, Bas, Urbanus, Rolf T., van de Beek, D., Brouwer, M. C., de Bruin, S., Coppens, M., van Es, N., van Haaps, T. F., Juffermans, N. P., Muller, M. C. A., Vlaar, A. P. J., Hertogh, C. M. P. M., Heunks, L. M. A., Hugtenburg, J. G., van Kooten, J., Nossent, E. J., Smulders, Y., Tuinman, P. R., Noordegraaf, A. Vonk, Grootenboers, M. J. J. H., van Guldener, C., Kant, M., Lansbergen, A., Faber, J., Hajer, G., Stemerdink, A., van den Akker, J., Bierings, R., Endeman, H., Goeijenbier, M., Hunfeld, N. G. M., van Gorp, E. C. M., Gommers, D. A. M. P. J., Koopmans, M. P. G., Kruip, M. J. H. A., Kuiken, T., Langerak, T., Leebeek, Lauw, M. N., de Maat, M. P. M., Noack, D., Paats, M. S., Raadsen, M. P., Rockx, B., Rokx, C., Schurink, C. A. M., Tong-Minh, K., van den Toorn, L., den Uil, C. A., Visser, C., Boutkourt, F., Roest, T., Douma, R. A., de Haan, L. R., ten Wolde, M., Bemelmans, R. H. H., Festen, B., Stads, S., de Jager, C. P. C., Simons, K. S., Antoni, M. L., Bos, M. H., Burggraaf, J. L. I., Cannegieter, S. C., Eikenboom, H. C. J., den Exter, P. L., Geelhoed, J. J. M., Huisman, M. V., de Jonge, E., Kaptein, F. H. J., Klok, F. A., Kroft, L. J. M., Lijfering, W. M., Nab, L., Ninaber, M. K., Putter, H., Ramai, S. R. S., da Rocha Rondon, A. M., Roukens, A. H. E., Stals, M. A. M., Versteeg, H. H., Vliegen, H. W., van Vlijmen, B. J. M., van de Berg, T., Bruggemann, R., van Bussel, B. C. T., ten Cate, H., ten Cate-Hoek, A., Hackeng, T. M., Henskens, ir. Y., Hulshof, A., Mulder, M., Olie, R. H., Schurgers, L., Spaetgens, B., Spronk, H., Spruit, M. A., Winckers, K., Nieuwenhuizen, L., Franken, B., Schrover, I. M., de Waal, E. G. M., Beishuizen, A., Cornet, A., Krabbe, J., Kramers, K., Leentjens, J., de Mast, Q., Middeldorp, S., Brouwer, R. E., Ellerbroek, J. L. J., Tijmensen, J., Hovens, M. M. C., Oostdijk, E. A. N., Westerhof, B. D., Faber, L. M., van den Biggelaar, M., Meijers, J. C. M., Voorberg, J., Kevenaar, M. E., Soei, Y. L., Wils, E. J., Croles, F. N., de Laat, B., Kamphuisen, P. W., Vink, R., Lisman, T., Meijer, K., van Tichelaar, Y. I. G., Cremer, O. L., Geersing, G., Kaasjager, H. A. H., Kusadasi, N., Huisman, A., Maas, C., Nijkeuter, M., Schutgens, R. E. G., Creveldkliniek, Van, Urbanus, R. T., Westerink, J., Faber, H. J., Koster, S. C. E., van Montfort, P., van Twist, D. J. L., RS: Carim - B01 Blood proteins & engineering, Biochemie, Hematology, Intensive Care, Neurology, ANS - Neuroinfection & -inflammation, Intensive Care Medicine, ACS - Pulmonary hypertension & thrombosis, AII - Inflammatory diseases, Vascular Medicine, ACS - Amsterdam Cardiovascular Sciences, Graduate School, ACS - Microcirculation, Medical Microbiology and Infection Prevention, ARD - Amsterdam Reproduction and Development, Experimental Vascular Medicine, Landsteiner Laboratory, ACS - Atherosclerosis & ischemic syndromes, Elderly care medicine, APH - Aging & Later Life, Clinical pharmacology and pharmacy, APH - Health Behaviors & Chronic Diseases, Pulmonary medicine, Internal medicine, ACS - Diabetes & metabolism, Intensive care medicine, General practice, and Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], lupus anticoagulant, risk factor, critically ill, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], COVID-19, Hematology, thrombosis, Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18]
Abstract

Contains fulltext : 286889.pdf (Publisher’s version ) (Open Access) BACKGROUND: Thrombosis is a frequent and severe complication in patients with coronavirus disease 2019 (COVID-19) admitted to the intensive care unit (ICU). Lupus anticoagulant (LA) is a strong acquired risk factor for thrombosis in various diseases and is frequently observed in patients with COVID-19. Whether LA is associated with thrombosis in patients with severe COVID-19 is currently unclear. OBJECTIVE: To investigate if LA is associated with thrombosis in critically ill patients with COVID-19. PATIENTS/METHODS: The presence of LA and other antiphospholipid antibodies was assessed in patients with COVID-19 admitted to the ICU. LA was determined with dilute Russell's viper venom time (dRVVT) and LA-sensitive activated partial thromboplastin time (aPTT) reagents. RESULTS: Of 169 patients with COVID-19, 116 (69%) tested positive for at least one antiphospholipid antibody upon admission to the ICU. Forty (24%) patients tested positive for LA; of whom 29 (17%) tested positive with a dRVVT, 19 (11%) tested positive with an LA-sensitive aPTT, and 8 (5%) tested positive on both tests. Fifty-eight (34%) patients developed thrombosis after ICU admission. The odds ratio (OR) for thrombosis in patients with LA based on a dRVVT was 2.5 (95% confidence interval [CI], 1.1-5.7), which increased to 4.5 (95% CI, 1.4-14.3) in patients at or below the median age in this study (64 years). LA positivity based on a dRVVT or LA-sensitive aPTT was only associated with thrombosis in patients aged less than 65 years (OR, 3.8; 95% CI, 1.3-11.4) and disappeared after adjustment for C-reactive protein. CONCLUSION: Lupus anticoagulant on admission is strongly associated with thrombosis in critically ill patients with COVID-19, especially in patients aged less than 65 years.

Published
2022
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5. Ruling out Pulmonary Embolism in Patients with (Suspected) COVID-19-A Prospective Cohort Study

Author

Stals, M.A.M., Kaptein, F.H.J., Bemelmans, R.H.H., Bemmel, T. van, Boukema, I.C., Braeken, D.C.W., Braken, S.J.E., Bresser, C., Cate, H.T., Deenstra, D.D., Dooren, Y., Faber, L.M., Grootenboers, M., Haan, L.R., Haazer, C., Sol, A.I.D., Kelliher, S., Koster, T., Kroft, L.J., Meijer, R.I., Pals, F., Thiel, E.R.E. van, Westerweel, P.E., Wolde, M.T., Klok, F.A., Huisman, M.V., Stals, M.A.M., Kaptein, F.H.J., Bemelmans, R.H.H., Bemmel, T. van, Boukema, I.C., Braeken, D.C.W., Braken, S.J.E., Bresser, C., Cate, H.T., Deenstra, D.D., Dooren, Y., Faber, L.M., Grootenboers, M., Haan, L.R., Haazer, C., Sol, A.I.D., Kelliher, S., Koster, T., Kroft, L.J., Meijer, R.I., Pals, F., Thiel, E.R.E. van, Westerweel, P.E., Wolde, M.T., Klok, F.A., and Huisman, M.V.

Abstract

Item does not contain fulltext, Background Diagnostic strategies for suspected pulmonary embolism (PE) have not been prospectively evaluated in COVID-19 patients. Methods Prospective, multicenter, outcome study in 707 patients with both (suspected) COVID-19 and suspected PE in 14 hospitals. Patients on chronic anticoagulant therapy were excluded. Informed consent was obtained by opt-out approach. Patients were managed by validated diagnostic strategies for suspected PE. We evaluated the safety (3-month failure rate) and efficiency (number of computed tomography pulmonary angiographies [CTPAs] avoided) of the applied strategies. Results Overall PE prevalence was 28%. YEARS was applied in 36%, Wells rule in 4.2%, and "CTPA only" in 52%; 7.4% was not tested because of hemodynamic or respiratory instability. Within YEARS, PE was considered excluded without CTPA in 29%, of which one patient developed nonfatal PE during follow-up (failure rate 1.4%, 95% CI 0.04-7.8). One-hundred seventeen patients (46%) managed according to YEARS had a negative CTPA, of whom 10 were diagnosed with nonfatal venous thromboembolism (VTE) during follow-up (failure rate 8.8%, 95% CI 4.3-16). In patients managed by CTPA only, 66% had an initial negative CTPA, of whom eight patients were diagnosed with a nonfatal VTE during follow-up (failure rate 3.6%, 95% CI 1.6-7.0). Conclusion Our results underline the applicability of YEARS in (suspected) COVID-19 patients with suspected PE. CTPA could be avoided in 29% of patients managed by YEARS, with a low failure rate. The failure rate after a negative CTPA, used as a sole test or within YEARS, was non-negligible and reflects the high thrombotic risk in these patients, warranting ongoing vigilance.

Published
2021

6. Incidence of thrombotic complications and overall survival in hospitalized patients with COVID-19 in the second and first wave

Author

Kaptein, F H J, Stals, M A M, Grootenboers, M, Braken, S J E, Burggraaf, J L I, van Bussel, B C T, Cannegieter, S C, Ten Cate, H, Endeman, H, Gommers, D A M P J, van Guldener, C, de Jonge, E, Juffermans, N P, Kant, K M, Kevenaar, M E, Koster, S, Kroft, L J M, Kruip, M J H A, Leentjens, J, Marechal, C, Soei, Y L, Tjepkema, L, Visser, C, Klok, F A, Huisman, M V, Kaptein, F H J, Stals, M A M, Grootenboers, M, Braken, S J E, Burggraaf, J L I, van Bussel, B C T, Cannegieter, S C, Ten Cate, H, Endeman, H, Gommers, D A M P J, van Guldener, C, de Jonge, E, Juffermans, N P, Kant, K M, Kevenaar, M E, Koster, S, Kroft, L J M, Kruip, M J H A, Leentjens, J, Marechal, C, Soei, Y L, Tjepkema, L, Visser, C, Klok, F A, and Huisman, M V

Abstract

INTRODUCTION: In the first wave, thrombotic complications were common in COVID-19 patients. It is unknown whether state-of-the-art treatment has resulted in less thrombotic complications in the second wave.METHODS: We assessed the incidence of thrombotic complications and overall mortality in COVID-19 patients admitted to eight Dutch hospitals between September 1st and November 30th 2020. Follow-up ended at discharge, transfer to another hospital, when they died, or on November 30th 2020, whichever came first. Cumulative incidences were estimated, adjusted for competing risk of death. These were compared to those observed in 579 patients admitted in the first wave, between February 24th and April 26th 2020, by means of Cox regression techniques adjusted for age, sex and weight.RESULTS: In total 947 patients with COVID-19 were included in this analysis, of whom 358 patients were admitted to the ICU; 144 patients died (15%). The adjusted cumulative incidence of all thrombotic complications after 10, 20 and 30 days was 12% (95% confidence interval (CI) 9.8-15%), 16% (13-19%) and 21% (17-25%), respectively. Patient characteristics between the first and second wave were comparable. The adjusted hazard ratio (HR) for overall mortality in the second wave versus the first wave was 0.53 (95%CI 0.41-0.70). The adjusted HR for any thrombotic complication in the second versus the first wave was 0.89 (95%CI 0.65-1.2).CONCLUSIONS: Mortality was reduced by 47% in the second wave, but the thrombotic complication rate remained high, and comparable to the first wave. Careful attention to provision of adequate thromboprophylaxis is invariably warranted.

Published
2021

7. Efficacy and Safety of Outpatient Treatment Based on the Hestia Clinical Decision Rule with or without N-Terminal Pro-Brain Natriuretic Peptide Testing in Patients with Acute Pulmonary Embolism A Randomized Clinical Trial: American Journal of Respiratory and Critical Care Medicine

Author

den Exter, P.L., Zondag, W., Klok, F.A., Brouwer, Rolf E., Dolsma, J., Eijsvogel, M., Faber, Laura M., van Gerwen, M.A.G., Grootenboers, M. J., Heller-Baan, R., Hovens, M.M., Jonkers, G.J.P.M., van Kralingen, K.W., Melissant, C.F., Peltenburg, H., Post, J. P., van de Ree, M.A., Vlasveld, L Thom, De Vreede, M.J.M., Huisman, M. V., Vesta Study, Investigators, Internal medicine, and ICaR - Heartfailure and pulmonary arterial hypertension

Abstract

Rationale: Outpatient treatment ofpulmonary embolism (PE) maylead to improved patient satisfaction and reduced healthcare costs. However, trials to assess its safety and the optimal method for patient selection are scarce. Objectives: To validate the utility and safety of selecting patients with PE for outpatient treatment by the Hestia criteria and to compare the safety of the Hestia criteria alone with the Hestia criteria combined with N-terminal pro-brain natriuretic peptide (NT-proBNP) testing. Methods: We performed a randomized noninferiority trial in 17 Dutch hospitals. We randomized patients with PE without any of the Hestia criteria to direct discharge or additional NT-proBNP testing. We discharged the latter patients as well if NT-proBNP did not exceed 500 ng/L or admitted them if NT-proBNP was greater than 500 ng/L. The primary endpoint was 30-day adverse outcome defined as PE- or bleeding-related mortality, cardiopulmonary resuscitation, or intensive care unit admission. The noninferiority margin for the primary endpoint was 3.4%. Measurements and Main Results: We randomized 550 patients. In the NT-proBNP group, 34 of 275 (12%) had elevated NT-proBNP values and were managed as inpatients. No patient (0 of 34) with an elevated NT-proBNP level treated in hospital (0%; 95% confidence interval [CI], 0-10.2%), versus no patient (0 of 23) with apost hoc-determined elevated NT-proBNP level from the direct discharge group (0%; 95% CI, 0-14.8%), experienced the primary endpoint. In both trial cohorts, the primary endpoint occurred in none of the 275 patients (0%; 95% CI, 0-1.3%) subjected to NT-proBNP testing, versus in 3 of 275 patients (1.1%; 95% CI, 02-3.2%) in the direct discharge group (P = 0.25). During the 3-month follow-up, recurrent venous thromboembolism occurred in two patients (0.73%; 95% CI, 0.1-2.6%) in the NT-proBNP group versus three patients (1.1%; 95% CI, 0.2-3.2%) in the direct discharge group (P = 0.65). Conclusions: Outpatient treatment of patients with PE selected on the basis of the Hestia criteria alone was associated with a low risk of adverse events. Given the low number of patients with elevated NT-proBNP levels, this trial was unable to draw definite conclusions regarding the incremental value of NT-proBNP testing in patients who fulfill the Hestia criteria.

Published
2016
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8. 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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9. [In-hospital treatment of COVID-19 patients].

Author

de Wee EM, van der Sar-van der Brugge S, Grootenboers M, Bentvelsen RG, Kant KM, and van der Leest CH

Subjects
Aged, COVID-19, Hospitalization, Humans, Male, Middle Aged, Netherlands, Pandemics, SARS-CoV-2, Betacoronavirus, Coronavirus Infections therapy, Intensive Care Units, Pneumonia, Viral therapy
Abstract

Covid-19 infection is now a pandemic disease. Most patients have mild symptoms without the need for hospitalization. On average, 5% of the COVID-19-positive patients have severe respiratory symptoms. We present 3 patients aged 45, 67 and 75 years, who were admitted to the ICU with severe respiratory symptoms. We describe the presentation of the COVID-19 patients on the emergency department, the development of the disease, and the treatment of these patients on the ICU.

Published
2020

10. Selective pulmonary artery perfusion for the treatment of primary lung cancer: Improved drug exposure of the lung.

Author

van Putte BP, Grootenboers M, van Boven WJ, van Oosterhout M, Pasterkamp G, Folkerts G, and Schramel F

Subjects
Animals, Antineoplastic Agents pharmacokinetics, Area Under Curve, Carboplatin pharmacokinetics, Deoxycytidine administration & dosage, Deoxycytidine pharmacokinetics, Female, Swine, Gemcitabine, Antineoplastic Agents administration & dosage, Carboplatin administration & dosage, Chemotherapy, Cancer, Regional Perfusion methods, Deoxycytidine analogs & derivatives, Lung Neoplasms drug therapy
Abstract

Introduction: Selective pulmonary artery perfusion (SPAP) is an experimental drug infusion method for the treatment of lung cancer that aims to achieve more effective T(umour) and lymph N(ode) down-staging. The aim of this experiment was to compare drug uptake of gemcitabine and carboplatin during SPAP and intravenous infusion (IV)., Material and Methods: SPAP was performed in 12 pigs using clinically applied doses of gemcitabine (1.25g/m(2), n=4) and carboplatin (AUC 5, n=4) and a combination of both (n=4). All animals underwent catheterisation of the left pulmonary artery and furthermore a left thoracotomy and lumbotomy for tissue sampling. After 2min of SPAP, 30min of blood flow occlusion was performed in order to delay drug washout from the lung. Two additional groups were infused intravenously (IV) using the same dose of gemcitabine (n=4) and carboplatin (n=4). Peak concentrations and area under the curve (AUC) were compared with t-tests., Results: Significantly higher pulmonary gemcitabine peak concentrations (p

Published
2009
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11. Pharmacokinetics of gemcitabine when delivered by selective pulmonary artery perfusion for the treatment of lung cancer.

Author

van Putte BP, Grootenboers M, van Boven WJ, Hendriks JM, van Schil PE, Guetens G, De Boeck G, Pasterkamp G, Schramel F, and Folkerts G

Subjects
Animals, Deoxycytidine administration & dosage, Deoxycytidine pharmacokinetics, Female, Lung drug effects, Lung metabolism, Lung Neoplasms drug therapy, Pulmonary Artery drug effects, Swine, Gemcitabine, Deoxycytidine analogs & derivatives, Drug Delivery Systems methods, Infusions, Intra-Arterial methods, Lung Neoplasms metabolism, Pulmonary Artery metabolism
Abstract

Lung cancer represents a major health problem. Cytostatic and radiotherapeutic treatment is limited because of dose-limiting systemic toxicity and surgery as a result of its invasive nature. Therefore, we developed a catheterization model of selective pulmonary artery perfusion (SPAP) combining the properties of isolated lung perfusion and i.v. treatment to achieve higher local drug levels and equivalent systemic exposure. Sixteen pigs underwent SPAP using a clinically applied dose of gemcitabine (1 g/m(2)). They furthermore underwent thoracotomy for tissue sampling. Three groups were treated with SPAP for 2 min with normal pulmonary blood flow, 50 and 90% flow reduction. Another group had SPAP for 10 min with normal blood flow. All the SPAP groups underwent catheterization of the left pulmonary artery. An additional group (n = 4) was infused i.v. for 30 min using the same dose. Concentrations were analyzed with analysis of variance. Pulmonary peak concentrations (p = 0.01) and areas under the curve (AUC) (p = 0.001) of SPAP for 2 and 10 min were significantly higher compared with i.v., whereas SPAP for 10 min resulted in the highest AUC (p = 0.045) compared with SPAP for 2 min. Flow reduction during SPAP resulted in inhomogeneous distribution. Liver levels, AUC (serum), and wet-to-dry ratios of all the SPAP groups were not significantly different compared with i.v. SPAP resulted in higher lung concentrations, whereas systemic exposure was comparable with i.v. Therefore, we advocate SPAP as a new method to be tested clinically to achieve down-staging of the tumor and lymph node status in lung cancer.

Published
2008
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12. Selective pulmonary artery perfusion: a novel method for the treatment of pulmonary malignancies.

Author

Grootenboers MJ, Schramel FM, Hendriks JM, Van Boven WJ, Van Schil PE, and Van Putte BP

Subjects
Animals, Antineoplastic Combined Chemotherapy Protocols adverse effects, Feasibility Studies, Humans, Injections, Intra-Arterial, Regional Blood Flow drug effects, Vascular Patency drug effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Chemotherapy, Cancer, Regional Perfusion methods, Lung Neoplasms drug therapy, Pulmonary Artery drug effects
Abstract

Selective pulmonary artery perfusion (SPAP) is a modality of regional chemotherapy first investigated in the 1950's. A number of studies in animal models documented pharmacokinetic superiority with high-dose local cytostatic drug concentrations when compared to intravenous administration. Blood flow occlusion of the pulmonary artery before or after drug injection results in further increase in local drug concentrations. Animal tumor models with sarcoma and coloncarcinoma confirm anti-tumour efficacy in cytostatic SPAP. In human investigations, feasibility and safety of chemotherapeutic SPAP in humans has been documented. Recent encouraging investigations of SPAP with gemcitabine and blood flow occlusion in a porcine model emphasize the need for further investigations in humans with pulmonary malignancies for safety and efficacy assessments.

Published
2007
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13. Isolated lung perfusion for pulmonary metastases.

Author

Hendriks JM, Van Putte BP, Grootenboers M, Van Boven WJ, Schramel F, and Van Schil PE

Subjects
Animals, Chemotherapy, Cancer, Regional Perfusion instrumentation, Humans, Models, Animal, Rats, Antineoplastic Agents administration & dosage, Chemotherapy, Cancer, Regional Perfusion methods, Lung Neoplasms drug therapy, Lung Neoplasms secondary, Tumor Necrosis Factor-alpha administration & dosage
Abstract

Isolated lung perfusion is an experimental surgical technique evaluated for the delivery of high-dose chemotherapy to improve 5-year survival after pulmonary metastasectomy. Extensive experimental work in animal models has demonstrated superior pharmacokinetics and efficacy compared with systemic therapy. Phase I clinical trials of isolated lung perfusion found a maximum tolerated dose**** of TNF-alpha, doxorubicin, cisplatin, and melphalan, whereas the combination of isolated lung perfusion with a complete metastasectomy was feasible. The combination of isolated lung perfusion and regional lung perfusion techniques needs further investigation.

Published
2006
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