1. PATCH: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial
- Author
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de Gans, Koen, de Haan, Rob J., Majoie, Charles B., Koopman, Maria M., Brand, Anneke, Dijkgraaf, Marcel G., Vermeulen, Marinus, Roos, Yvo B., Hofmeijer, J., Vermeer, S. E., Franke, C. L., Mulleners, W. M., Keizer, K., Dijkstra, U. J., van Kooten, F., Bronner, I. M., Kloos, L. M. H., Viseé, H. F., de Bruijn, S. F. T. M., Bienfait, H. M. E., Saxena, R., Meilof, J. F., Raaijmakers, T. W. M., Brans, J. W. M., Jellema, K., Schuiling, W. J., Portegies, P., Rooyer, F. A., Aerden, L. A. M., van der Meulen, W. D. M., de Kruijk, J. R., Jansen, B. P. W., Kwa, V. I. H., Meijer, R. J., Boon, A. E., Schonewille, W. J., de Kort, P. L. M., Bakker, S. L. M., Hofstee, D. J., van den Berg-Vos, R. M., van Dijk, E. J., Klijn, C. J. M., Verhey, J. C. B., Visser, M. C., van der Ree, T. C., Reitsma, J. B., Kamphuisen, P. W., Klijn, C. J., Zinkstok, S. M., Faculteit der Geneeskunde, Amsterdam Cardiovascular Sciences, Amsterdam Neuroscience, Neurology, Amsterdam Public Health, Clinical Research Unit, Radiology and Nuclear Medicine, Amsterdam Gastroenterology Endocrinology Metabolism, Epidemiology and Data Science, Other departments, Amsterdam institute for Infection and Immunity, and Vascular Medicine
- Subjects
medicine.medical_specialty ,Neurology ,Time Factors ,Clinical Neurology ,Platelet Transfusion ,lcsh:RC346-429 ,law.invention ,Randomized controlled trial ,Clinical Protocols ,law ,Study protocol ,medicine ,Humans ,Neurochemistry ,cardiovascular diseases ,Prospective Studies ,Prospective cohort study ,lcsh:Neurology. Diseases of the nervous system ,Cerebral Hemorrhage ,business.industry ,Brain ,General Medicine ,Clopidogrel ,Surgery ,Platelet transfusion ,Treatment Outcome ,Research Design ,Anesthesia ,Acute Disease ,Platelet aggregation inhibitor ,Neurology (clinical) ,Neurosurgery ,business ,Platelet Aggregation Inhibitors ,medicine.drug ,Follow-Up Studies - Abstract
Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303)
- Published
- 2010