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evident
2016LancetNeurology

PATCH

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

Overview

In antiplatelet-associated ICH, platelet transfusion increased death or dependence compared with standard care and should not be used routinely.

Clinical takeaway

Platelet transfusion for antiplatelet-associated ICH worsened functional outcome and should not be routine.

Key result

Death or dependence at 3 months was more likely with platelet transfusion (adjusted common OR 2.05; 95% CI 1.18-3.56; p=0.0114).

Practice impact

Do not give platelets to reverse antiplatelet therapy in spontaneous ICH.

Evidence

Study design

Multicentre, open-label, masked-endpoint, randomised phase 3 trial.

Enrollment

190

Follow-up

Modified Rankin Scale assessed at 3 months.

Geography

Netherlands, UK, France

Clinical question

Does platelet transfusion plus standard care reduce death or dependence after antiplatelet-associated intracerebral hemorrhage?

Population

  • Adults within 6 hours of supratentorial intracerebral hemorrhage who had used antiplatelet therapy for at least 7 days and had a Glasgow Coma Scale score of at least 8.

Intervention

Standard care plus platelet transfusion within 90 minutes of diagnostic brain imaging.

Comparator

Standard care alone.

Primary outcome

Shift toward death or dependence on the modified Rankin Scale at 3 months.

Platelet transfusion increased the odds of death or dependence compared with standard care.

Adjusted common odds ratio / 2.05 / 95% CI 1.18-3.56 / p=0.0114

Key results

  • The odds of death or dependence at 3 months were higher with platelet transfusion (adjusted common OR 2.05; 95% CI 1.18-3.56; p=0.0114).
  • In-hospital death occurred in 24% assigned to platelet transfusion and 17% assigned to standard care.

Harms

  • Serious adverse events during the hospital stay occurred in 42% with platelet transfusion and 29% with standard care.
  • In-hospital death occurred in 24% assigned to platelet transfusion and 17% assigned to standard care.

Clinical Use

Practice impact

  • Do not give platelets to reverse antiplatelet therapy in spontaneous ICH.

Applicability

  • Most applicable to supratentorial ICH within 6 hours in adults on antiplatelet therapy for at least 7 days with GCS of 8 or more.

Limitations

  • Treatment assignment was open-label; outcome assessors were masked.
  • The trial enrolled only 190 participants across 41 sites.
  • It does not address platelet transfusion for thrombocytopenia or for a planned operation.

Common misinterpretations

  • This is harm, not a neutral 'no benefit' result.
  • Do not apply PATCH to every ICH patient who has ever taken an antiplatelet; the enrolled population was early, supratentorial, and GCS 8 or higher.

Citation

Baharoglu MI, Cordonnier C, Al-Shahi Salman R, et al. 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. Lancet. 2016;387(10038):2605-2613. doi:10.1016/S0140-6736(16)30392-0

Platelet transfusion seems inferior to standard care for people taking antiplatelet therapy before intracerebral haemorrhage.