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: Difference between revisions

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==Clinical Question==
==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?
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?
   
   


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==Major Points==  
==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/>  
*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>  
http://www.thelancet.com/pdfs/journals/laneur/PIIS1474-4422(09)70025-0.pdf
<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  
*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==
==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
*Multicenter, randomized, open-label, parallel-group trial in 36 hospitals in the Netherlands, 13 hospitals in UK and 11 hospitals in France
Stratified by type of ICH antiplatelet therapy whether ASA, clopidogrel, ASA+ dipyramidole, ASA +clopidogrel)
*Randomized with number generator
NIHSS calculated for all patients
*Stratified by  
Brain imaging done
**type of ICH  
Standard care- leuucocyte-depleted platelet transfusions
**antiplatelet therapy whether ASA, clopidogrel, ASA+ dipyramidole, ASA +clopidogrel)
Platelet transfusion initiated within 6 hours of ICH symptom onset and within 90 minutes
*NIHSS calculated for all patients
*One platelet for patients on ASA or ASA+dipyramidole
*Brain imaging done
*Two platelets for patients on ASA+clopidogrel
*Standard care- leucocyte-depleted platelet transfusions
Measured Rankin score 3 months from initial platelet transfusion
*Platelet transfusion initiated within 6 hours of ICH symptom onset and within 90 minutes
Imaging at 24 hours after randomization
**One platelet for patients on ASA or ASA+dipyramidole
Stratified the analysis  
**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  
**ICH volume size  
**hospitals where treatments took place
**hospitals where treatments took place
Adverse events  
*Adverse events  
*Transfusion reactions, thrombotic complications
**Transfusion reactions, thrombotic complications
*Hemorrhage enlargement
**Hemorrhage enlargement
*Intraventricular extension
**Intraventricular extension
*Hydrocephalus
**Hydrocephalus
*Edema,
**Edema
*Brain herniation
**Brain herniation
*Epileptic seizures
**Epileptic seizures
*Infection
**Infection


==Population==
==Population==
Patients greater than 18 on an anti-platelet agent with atraumatic ICH presenting to 60 hospitals in Netherlands, UK and France
===Patient Demographics===
===Patient Demographics===
===Inclusion Criteria===
===Inclusion Criteria===
  Must meet all the criteria
  Must meet all the criteria


18 years or older with nontraumatic supratentorial intracerebral hemorrhage confirmed by brain imaging   
*18 years or older with nontraumatic supratentorial intracerebral hemorrhage confirmed by brain imaging   
GCS 8-15
*GCS>8
Platelet transfusion could be initiated within
*Platelet transfusion could be initiated within
*6 hours of symptom onset and
**6 hours of symptom onset and
* 90 min of brain imaging
** 90 min of brain imaging
On antiplatelet therapy for at least 7 days prior either
*On antiplatelet therapy for at least 7 days prior either
**Aspirin, Carbasalate calcium, clopidogrel, dipyridamole
**Aspirin, Carbasalate calcium, clopidogrel, dipyridamole
pre-intracerbral hemorrhage modified Rankin Scale of 0 or 1
*Pre-intracerbral hemorrhage modified Rankin Scale of 0 or 1


===Exclusion Criteria===


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


==Interventions==  
==Interventions==  
   
   
*1 or 2 unit platelet transfusion
==Outcomes==
==Outcomes==
   
   


===Primary Outcome===
===Primary Outcome===
  Death at three months or growth of ICH at three months
  Death at three months or growth of ICH at three months


===Secondary Outcomes===  
===Secondary Outcomes===  
   
   
Any adverse events
Any adverse events
42% in platelet transfusion had adverse event
42% in platelet transfusion had adverse event
29% in standard therapy had adverse event
29% in standard therapy had adverse event


ICH enlargement, brain edema, brain herniation, intraventricular extension, hydrocephalus  
*ICH enlargement, brain edema, brain herniation, intraventricular extension, hydrocephalus  
Urinary or pulmonary infections
*Urinary or pulmonary infections
Thromboembolism – ischemic stroke, myocardial infarction, extremity embolism, pulmonary embolism
*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
*Transfusion reactions- nonhemolytic, anaphylactic, acute lung injury, post-transfusion purpura, graft versus host disease, transmitted bacterial infection
seizures
seizures


===Subgroup analysis===
===Subgroup analysis===
   
   


Revision as of 12:27, 6 July 2017

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

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 [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
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