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

• Published in: The Lancet (British edition) 2016-06, Vol.387 (10038), p.2605-2613
• Main Authors: Baharoglu, M Irem, MD, Cordonnier, Charlotte, Prof, Salman, Rustam Al-Shahi, Prof, de Gans, Koen, MD, Koopman, Maria M, PhD, Brand, Anneke, Prof, Majoie, Charles B, Prof, Beenen, Ludo F, PhD, Marquering, Henk A, PhD, Vermeulen, Marinus, Prof, Nederkoorn, Paul J, PhD, de Haan, Rob J, Prof, Roos, Yvo B, Prof
• Format: Article
• Language: English
• Subjects: Adenosine; Adult; Aged; Aged, 80 and over; Blood platelets; Blood transfusions; Brain; Brain research; Cerebral Hemorrhage - chemically induced; Cerebral Hemorrhage - mortality; Cerebral Hemorrhage - therapy; Clinical trials; Coma; Death; Dependence; Diagnostic systems; Drug therapy; Embolisms; Ethics; Europe; Evidence-based medicine; Fatalities; Female; Heart; Hemorrhage; Hospitals; Human health and pathology; Humans; Internal Medicine; Length of Stay; Life Sciences; Male; Medical imaging; Middle Aged; Mortality; Neuroimaging; Platelet Aggregation Inhibitors - adverse effects; Platelet Transfusion; Platelets; Population; R&D; Randomization; Regression analysis; Research & development; Stroke; Stroke - chemically induced; Stroke - mortality; Stroke - therapy; Therapy; Transfusion; Treatment Outcome
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(16)30392-0

Summary 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