View source for 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

{{JC info
| title= 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.
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| published= 
| author= 
| journal= Lancet
| year= 2016
| volume= 
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| pages= 2605-13
| pmid= 
| fulltexturl= http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)30392-0/fulltext
| pdfurl=
}}

==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 <ref> Al-Shahi Salman, R, Labovitz, DL, and Stapf, C. Spontaneous intracerebral haemorrhage. BMJ. 2009; 339: b2586 </ref><ref> http://www.thelancet.com/pdfs/journals/laneur/PIIS1474-4422(09)70025-0.pdf </ref>
*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==
*[[Intracranial hemorrhage (main)]]

==Funding==

==References==
<references/>

[[Category:EBQ]]