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?
 


==Conclusion==
==Conclusion==
*Patients who are on antiplatelet therapy who suffer from a primary [[intracranial hemorrhage]] (ICH) had increased serious adverse events during hospital stay.  
In 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.
 
Platelets are not routinely recommended for patients on antiplatelet therapy who have an ICH.  


==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><ref> http://www.thelancet.com/pdfs/journals/laneur/PIIS1474-4422(09)70025-0.pdf </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/>  
*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
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==
==Study Design==
Multicenter, randomized, open-label, parallel-group trial in 36 hospitals in the Netherlands, 13 hospitals in UK and 11 hospitals in France
*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
*Randomized with number generator
Stratified by type of ICH antiplatelet therapy whether ASA, clopidogrel, ASA+ dipyramidole, ASA +clopidogrel)
*Stratified by  
NIHSS calculated for all patients
**type of ICH  
Brain imaging done
**antiplatelet therapy whether ASA, clopidogrel, ASA+ dipyramidole, ASA +clopidogrel)
Standard care- leuucocyte-depleted platelet transfusions
*NIHSS calculated for all patients
Platelet transfusion initiated within 6 hours of ICH symptom onset and within 90 minutes
*Brain imaging done
*One platelet for patients on ASA or ASA+dipyramidole
*Standard care- leucocyte-depleted platelet transfusions
*Two platelets for patients on ASA+clopidogrel
*Platelet transfusion initiated within 6 hours of ICH symptom onset and within 90 minutes
Measured Rankin score 3 months from initial platelet transfusion
**One platelet for patients on ASA or ASA+dipyramidole
Imaging at 24 hours after randomization
**Two platelets for patients on ASA+clopidogrel
Stratified the analysis  
*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
GCS 8-15
**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===
===Exclusion Criteria===
Treating physician thinks imaging suggestive of epidural or subdural hematoma
*Treating physician thinks imaging suggestive of epidural or subdural hematoma
Underlying anseurysm, AVM
*Underlying anseurysm, AVM
Planned surgical evacuation of ICH within 24 hours of admission
*Planned surgical evacuation of ICH within 24 hours of admission
IV blood more than sedimentation in the posterior horns of the lateral ventricles
*IV blood more than sedimentation in the posterior horns of the lateral ventricles
Previous adverse reaction to platelet transfusion
*Previous adverse reaction to platelet transfusion
Known use of vitamin K antagonist
*Known use of vitamin K antagonist
History of coagulopathy
*History of coagulopathy
Known thrombocytopenia
*Known thrombocytopenia
Lacking mental capacity by national legal standards prior to ICH
*Lacking mental capacity by national legal standards prior to ICH
Death appeared imminent
*Death appeared imminent
Infratentorial or large IVH 2/2 likely to undergo surgery
*Infratentorial or large IVH 2/2 likely to undergo surgical Interventions
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  
 
*Urinary or pulmonary infections
ICH enlargement, brain edema, brain herniation, intraventricular extension, hydrocephalus  
*Thromboembolism – ischemic stroke, myocardial infarction, extremity embolism, pulmonary embolism
Urinary or pulmonary infections
*Transfusion reactions- nonhemolytic, anaphylactic, acute lung injury, post-transfusion purpura, graft versus host disease, transmitted bacterial infection
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
seizures


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


==Criticisms & Further Discussion==
==Criticisms & Further Discussion==
*Randomized trial of 189 participants who were taking antiplatelet therapy with atraumatic ICH
*Randomized trial of 189 participants who were taking antiplatelet therapy with atraumatic ICH
*platelet transfusion did not improve patient outcomes
*platelet transfusion did not improve patient outcomes


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==See Also==
==See Also==
*[[Intracranial hemorrhage (main)]]


==Funding==
==Funding==

Latest revision as of 02:52, 22 October 2018

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
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