Background

Spontaneous, non-traumatic, intracerebral hemorrhagic strokes accounts for 11-22% of incidence strokes but 50% of all stroke deaths. There are about 2 million of these bleeds a year world-wide. Many patients with these types of bleeds and strokes in general will be on anti platelet agents like aspirin and clopidogrel. Anti-platelet therapy has been shown to increase incidence of and worsen outcome of spontaneous intracerebral hemorrhage. It is common practice in many places to administer platelet transfusion to these patients in order to aid with clot formation and halt hemorrhage expansion. While this pathophysiologically makes sense, there’s little evidence to back up this approach.

Clinical Question

Does platelet transfusion reduce death or dependence compared to standard care in patients with spontaneous intracerebral hemorrhage on antiplatelet medications?

Population

Patients >18 y/o with spontaneous intracerebral hemorrhage on antiplatelet therapy for at least 7 days prior to presentation who present within 6 hours of symptoms

Intervention

Transfusion of platelets (1 platelet concentrate for COX inhibitor, 2 platelet concentrate for ADP receptor inhibitor) within 90 minutes of imaging showing intracranial hemorrhage

Control

Standard care according to contemporary European and national guidelines

Outcomes

Primary:Shift towards death or dependence based on the modified Rankin Scale (mRS) at 3 months.
Secondary: Poor outcome defined as mRS 3-6, poor outcome defined as mRS 4-6, median absolute ICH growth after 24 hours, complications of platelet transfusion, other serious adverse events.

Design

Multicenter, open-label, randomized controlled clinical trial conducted in intention-to-treat analysis. Participants and treating clinicians were unblinded, though data analysts & follow-up radiologists/neurologists were blinded.

Excluded

Imaging suspicious for epidural or subdural hemorrhage, imaging suspicious for aneurysm or arteriovenous malformation, planned surgical evacuation within 24 hours, previous adverse reaction to platelet transfusion, on vitamin K antagonist or thrombocytopenia.

Primary Results

  • 190 patients enrolled over 6 1/2 years in 41 hospitals.
  • 97 patients assigned to standard care w/ platelet transfusions, 93 patients to standard care alone
  • No significant differences in baseline gender, age, medical comorbidities.
  • Baseline ICH size was larger and the number of patients with GCS 5-12 was higher in the platelet transfusion group, while the proportion of patients with intraventricular extension was larger in the standard care group.

Critical Findings:

  • Increased death/dependence in patients receiving platelet transfusion (primary endpoint)
    • Crude OR 1.84 (95% CI 1.10 – 3.08)
    • Adjusted OR 2.05 (95% CI 1.18-3.56)
  • Secondary Outcomes
    • Platelets vs. Standard Care: mRS 4-6 at 3 months 72% vs 52%
  • No difference in survival, ICH growth, % mRS 3-6 at 3 months

Strengths

  • This is the first randomized trial to investigate the role of platelet transfusion in this population
  • Multicenter, multinational study
  • Randomization was appropriately performed
  • The primary outcome was clear and patient centered
  • Follow-up was complete; no patients were lost at 90 days

Limitations

  • Patients and clinical providers were not blinded to treatment allocation (this likely favors the platelet transfusion arm)
  • Relatively small study which may have led to the baseline differences seen in ICH size, GCS and intraventricular extension
  • The vast majority of patients were on aspirin as their anti platelet agents with very few taking ADP antagonist agents. Results may not be generalizable to antiplatelet medications other than aspirin

Author's Conclusions

“Platelet transfusion seems inferior to standard care for people taking anti-platelet therapy before intracerebral hemorrhage. Platelet transfusion cannot be recommended for this indication in clinical practice.”

Our Conclusions

The PATCH trial demonstrated that patients on aspirin with spontaneous intracerebral hemorrhage do not benefit from platelet transfusion. In fact, these patients appeared to have a higher odds of harm accrued from platelet administration. This study does not apply to traumatic hemorrhages or hemorrhages amenable to surgical or interventional radiology intervention.

Potential Impact To Current Practice

This study represents the best evidence to date on the utility of platelet transfusions in patients with spontaneous intracerebral hemorrhage who are taking antiplatelet agents. Based on this study, it should not be standard care to administer this treatment.

Bottom Line

Platelet transfusion for patients with spontaneous intracerebral hemorrhage on antiplatelet agents could be harmful, and at the very least, is not shown to be beneficial.

Read More

REBEL EM: The PATCH Trial: Hold the Platelets in Spontaneous Intracerebral Hemorrhage?

St. Emlyn’s: JC – Platelets for Intracranial Haemorrhage

EM Lit of Note: Put the Platelets Away in ICH