PATCH trial - no platelet transfusion for ICH

Short Attention Span Summary

It makes sense that patients on antiplatelet agents with spontaneous ICH would benefit from transfusion of new, sticky platelets.  But this multicenter study found that it increased the odds of death or dependence at 3 months by 105% (Odds ratio 2.05).  And more in the transfusion group died while still in the hospital.  You may want to mention this study the next time neurosurgery asks you to do this, in case they haven't read the latest in Lancet.



Abstract

Lancet. 2016 May 9. pii: S0140-6736(16)30392-0. doi: 10.1016/S0140-6736(16)30392-0. [Epub ahead of print]

Platelet transfusion versus standard care after acute stroke due to spontaneous cerebral haemorrhage associated with antiplatelet therapy (PATCH): a randomised, open-label, phase 3 trial.

Baharoglu MI1, Cordonnier C2, Salman RA3, de Gans K4, Koopman MM5,Brand A5, Majoie CB6, Beenen LF6, Marquering HA7, Vermeulen M1,Nederkoorn PJ1, de Haan RJ8, Roos YB9; PATCH Investigators.

Author information:

1Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands.

2Université Lille, Inserm U1171, Degenerative and Vascular Cognitive Disorders, CHU Lille, Department of Neurology, Lille, France.

3Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.

4Department of Neurology, Groene Hart Ziekenhuis, Gouda, Netherlands.

5Sanquin Bloodbank, Amsterdam, Netherlands.

6Department of Radiology, Academic Medical Centre, Amsterdam, Netherlands.

7Department of Radiology, Academic Medical Centre, Amsterdam, Netherlands; Department of Biomedical Engineering and Physics, Academic Medical Centre, Amsterdam, Netherlands.

8Clinical Research Unit, Academic Medical Centre, Amsterdam, Netherlands.

9Department of Neurology, Academic Medical Centre, Amsterdam, Netherlands. Electronic address: y.b.roos@amc.uva.nl.

 

Abstract

BACKGROUND:

Platelet transfusion after acute spontaneous primary intracerebral haemorrhage in people taking antiplatelet therapy might reduce death or dependence by reducing the extent of the haemorrhage. We aimed to investigate whether platelet transfusion with standard care, compared with standard care alone, reduced death or dependence after intracerebral haemorrhage associated with antiplatelet therapy use.

METHODS:

We did this multicentre, open-label, masked-endpoint, randomised trial at 60 hospitals in the Netherlands, UK, and France. We enrolled adults within 6 h of supratentorial intracerebral haemorrhage symptom onset if they had used antiplatelet therapy for at least 7 days beforehand and had a Glasgow Coma Scale score of at least 8. With use of a secure web-based system that concealed allocation and used biased coin randomisation, study collaborators randomly assigned participants (1:1; stratified by hospital and type of antiplatelet therapy) to receive either standard care or standard care with platelet transfusion within 90 min of diagnostic brain imaging. Participants and local investigators giving interventions were not masked to treatment allocation, but allocation was concealed from outcome assessors and investigators analysing data. The primary outcome was shift towards death or dependence rated on the modified Rankin Scale (mRS) at 3 months, and analysed by ordinal logistic regression, adjusted for stratification variables and the Intracerebral Haemorrhage Score. The primary analysis was done in the intention-to-treat population and safety analyses were done in the intention-to-treat and as-treated populations. This trial is registered with the Netherlands Trial Register, number NTR1303, and is now closed.

FINDINGS:

Between Feb 4, 2009, and Oct 8, 2015, 41 sites enrolled 190 participants. 97 participants were randomly assigned to platelet transfusion and 93 to standard care. The odds of death or dependence at 3 months were higher in the platelet transfusion group than in the standard care group (adjusted common odds ratio 2·05, 95% CI 1·18-3·56; p=0·0114). 40 (42%) participants who received platelet transfusion had a serious adverse event during their hospital stay, as did 28 (29%) who received standard care. 23 (24%) participants assigned to platelet transfusion and 16 (17%) assigned to standard care died during hospital stay.

INTERPRETATION:

Platelet transfusion seems inferior to standard care for people taking antiplatelet therapy before intracerebral haemorrhage. Platelet transfusion cannot be recommended for this indication in clinical practice.

FUNDING:

The Netherlands Organisation for Health Research and Development, Sanquin Blood Supply, Chest Heart and Stroke Scotland, French Ministry of Health.

TRIAL REGISTRATION:

ClinicalTrials.gov .

Copyright © 2016 Elsevier Ltd. All rights reserved.

PMID: 27178479 [PubMed - as supplied by publisher]

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