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
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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
In patients who are on antiplatelet therapy who suffer from a primary intracranial hemorrhage (ICH), had increased serious adverse events during hospital stay.
Platelets are not routinely recommended for patients on antiplatelet therapy who have an ICH.
Major Points
Hemorrhagic stroke is responsible for half of all stroke deaths with atraumatic ICH accounting for 2.3 of hemorrhagic strokes <ref> Al-Shahi Salman, R, Labovitz, DL, and Stapf, C. Spontaneous intracerebral haemorrhage. BMJ. 2009; 339: b2586Cite error: The opening <ref> tag is malformed or has a bad name
http://www.thelancet.com/pdfs/journals/laneur/PIIS1474-4422(09)70025-0.pdf
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
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- leuucocyte-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
Patient Demographics
Inclusion Criteria
Must meet all the criteria
18 years or older with nontraumatic supratentorial intracerebral hemorrhage confirmed by brain imaging GCS 8-15 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 surgery Interventions
Interventions
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