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Open Access Study protocol

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

Koen de Gans1*, Rob J de Haan2, Charles B Majoie3, Maria M Koopman4, Anneke Brand56, Marcel G Dijkgraaf7, Marinus Vermeulen1, Yvo B Roos12 and the PATCH Investigators

Author Affiliations

1 Department of Neurology, Academic Medical Centre, H2-222, PO-box 22660 1100 DD Amsterdam, The Netherlands

2 Clinical Research Unit, Academic Medical Centre, PO-box 22660 1100 DD Amsterdam, The Netherlands

3 Department of Radiology, Academic Medical Centre, PO-box 22660 1100 DD Amsterdam, The Netherlands

4 Sanquin Blood Bank, North West Region, PO-box 9137, 1006 AC Amsterdam, The Netherlands

5 Sanquin Blood Bank, South West Region, Department of Research and Development, Leiden, The Netherlands

6 Department of Immune-Haematology and Transfusion Medicine, Leiden University Medical Centre, Leiden, The Netherlands

7 Department of Clinical Epidemiology and Biostatistics, Academic Medical Centre, PO-box 22660 1100 DD Amsterdam, The Netherlands

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BMC Neurology 2010, 10:19  doi:10.1186/1471-2377-10-19

Published: 18 March 2010

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)