Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

• Published in: BMC neurology Vol. 10; no. 1; p. 19
• Main Authors: de Gans, Koen, de Haan, Rob J, Majoie, Charles B, Koopman, Maria M, Brand, Anneke, Dijkgraaf, Marcel G, Vermeulen, Marinus, Roos, Yvo B
• Format: Journal Article
• Language: English
• Published: London BioMed Central 18.03.2010; BioMed Central Ltd; BMC
• Subjects: Acute Disease; Anticoagulants; Blood platelets; Brain - drug effects; Brain - pathology; Care and treatment; Cerebral Hemorrhage - drug therapy; Cerebral Hemorrhage - pathology; Cerebral Hemorrhage - therapy; Clinical Protocols; Drug therapy; Epidemiology; Ethics; Follow-Up Studies; Hospitals; Human subjects; Humans; Intracerebral hemorrhage; Medicine; Medicine & Public Health; Mortality; Neurochemistry; Neurology; Neurosurgery; Patient outcomes; Platelet Aggregation Inhibitors - therapeutic use; Platelet Transfusion - adverse effects; Platelet Transfusion - methods; Prognosis; Prospective Studies; Research Design; Studies; Study Protocol; Time Factors; Transfusion; Treatment Outcome; Netherlands; Spot Sign; Clopidogrel; Haematoma Volume; Platelet Transfusion; Modify Rankin Scale
• ISSN: 1471-2377; 1471-2377
• DOI: 10.1186/1471-2377-10-19

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)