Statistical analysis plan for the PlAtelet Transfusion in Cerebral Haemorrhage (PATCH) trial: a multicentre...

Area of Science:

• Neurology
• Hematology
• Clinical Trials

Background:

• Antiplatelet therapy use before spontaneous intracerebral hemorrhage (ICH) is linked to increased fatality.
• The PlAtelet Transfusion in Cerebral Haemorrhage (PATCH) trial was designed to address this clinical challenge.

Purpose of the Study:

• To evaluate the efficacy of platelet transfusion in reducing death or dependence in patients with ICH who were on antiplatelet therapy.
• To determine if platelet transfusion could mitigate ICH growth.

Main Methods:

• A multicentre, prospective, randomised, open-label, blinded-endpoint (PROBE) trial involving 190 patients with spontaneous supratentorial ICH.
• Patients on antiplatelet therapy for at least 7 days prior to ICH were randomised (1:1) to receive either platelet transfusion or standard care.
• The primary outcome was the modified Rankin Scale (mRS) score at 3 months, assessed blindly to treatment allocation.

Main Results:

• The study aimed to assess the effect of platelet transfusion on reducing death or dependence.
• Key secondary outcomes included ICH growth, survival rates, and disability scores.

Conclusions:

• The PATCH trial investigated the impact of platelet transfusion on outcomes for ICH patients using antiplatelet therapy.
• Further analysis of the trial data is required to fully understand the treatment effects and safety profile.