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

incomplete Journal Club Article
. "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. :2605-13.
PubMed Full text

Clinical Question

In patients on antiplatelet therapy with acute spontaneous primary intracranial hemorrhage, does a platelet transfusion with standard care result in reduced death or spread of the intracerebral hemorrhage compared to standard care alone?

Conclusion

  • Patients who are on antiplatelet therapy who suffer from a primary intracranial hemorrhage (ICH) had increased serious adverse events during hospital stay.
  • However, platelets are not routinely recommended for patients on antiplatelet therapy who have ICH.

Major Points

  • Hemorrhagic stroke is responsible for half of all stroke deaths with atraumatic ICH accounting for 2.3 of hemorrhagic strokes [1][2]
  • Given than over a quarter of all patients with ICH are on antiplatelet therapy and that platelet transfusions have been used in these patients 18, this study sought to do a randomized controlled trial to see if data supports its use

Study Design

  • Multicenter, randomized, open-label, parallel-group trial in 36 hospitals in the Netherlands, 13 hospitals in UK and 11 hospitals in France
  • Randomized with number generator
  • Stratified by
    • type of ICH
    • antiplatelet therapy whether ASA, clopidogrel, ASA+ dipyramidole, ASA +clopidogrel)
  • NIHSS calculated for all patients
  • Brain imaging done
  • Standard care- leucocyte-depleted platelet transfusions
  • Platelet transfusion initiated within 6 hours of ICH symptom onset and within 90 minutes
    • One platelet for patients on ASA or ASA+dipyramidole
    • Two platelets for patients on ASA+clopidogrel
  • Measured Rankin score 3 months from initial platelet transfusion
  • Imaging at 24 hours after randomization
  • Stratified the analysis
    • ICH volume size
    • hospitals where treatments took place
  • Adverse events
    • Transfusion reactions, thrombotic complications
    • Hemorrhage enlargement
    • Intraventricular extension
    • Hydrocephalus
    • Edema
    • Brain herniation
    • Epileptic seizures
    • Infection

Population

Patients greater than 18 on an anti-platelet agent with atraumatic ICH presenting to 60 hospitals in Netherlands, UK and France

Patient Demographics

Inclusion Criteria

  • Must meet all the criteria
    • 18 years or older with nontraumatic supratentorial intracerebral hemorrhage confirmed by brain imaging
    • GCS>8
    • Platelet transfusion could be initiated within
      • 6 hours of symptom onset and
      • 90 min of brain imaging
    • On antiplatelet therapy for at least 7 days prior either
      • Aspirin, Carbasalate calcium, clopidogrel, dipyridamole
    • Pre-intracerbral hemorrhage modified Rankin Scale of 0 or 1

Exclusion Criteria

  • Treating physician thinks imaging suggestive of epidural or subdural hematoma
  • Underlying anseurysm, AVM
  • Planned surgical evacuation of ICH within 24 hours of admission
  • IV blood more than sedimentation in the posterior horns of the lateral ventricles
  • Previous adverse reaction to platelet transfusion
  • Known use of vitamin K antagonist
  • History of coagulopathy
  • Known thrombocytopenia
  • Lacking mental capacity by national legal standards prior to ICH
  • Death appeared imminent
  • Infratentorial or large IVH 2/2 likely to undergo surgical Interventions

Interventions

  • 1 or 2 unit platelet transfusion

Outcomes

Primary Outcome

Death at three months or growth of ICH at three months

Secondary Outcomes

  • Any adverse events
    • 42% in platelet transfusion had adverse event
    • 29% in standard therapy had adverse event
  • ICH enlargement, brain edema, brain herniation, intraventricular extension, hydrocephalus
  • Urinary or pulmonary infections
  • Thromboembolism – ischemic stroke, myocardial infarction, extremity embolism, pulmonary embolism
  • Transfusion reactions- nonhemolytic, anaphylactic, acute lung injury, post-transfusion purpura, graft versus host disease, transmitted bacterial infection

seizures

Subgroup analysis

Criticisms & Further Discussion

  • Randomized trial of 189 participants who were taking antiplatelet therapy with atraumatic ICH
  • platelet transfusion did not improve patient outcomes
  • European countries (high income countries- can this be generalized to lower income countries)
  • Small sample size
  • most patients were on Aspirin unclear if this can be generalized to patients on only Plavix
  • unknown if patients were actually compliant with medications, did it based on self report
  • 19% of participants met at least one of the exclusion outcomes


External Links

See Also

Funding

References

  1. Al-Shahi Salman, R, Labovitz, DL, and Stapf, C. Spontaneous intracerebral haemorrhage. BMJ. 2009; 339: b2586
  2. http://www.thelancet.com/pdfs/journals/laneur/PIIS1474-4422(09)70025-0.pdf