Platelet Transfusion in Acute Intracerebral Hemorrhage

Study Overview
=================
Brief Summary
-----------------
To prove whether use of antiplatelet agents results into a rapid enlargement of hematoma after onset of acute intracerebral hemorrhage. To prove the efficacy and safety of platelet transfusion for prevention of hematoma growth in patients who were stricken by acute intracerebral hemorrhage while being on antiplatelet medication.

Detailed Description
-----------------
Hematoma growth is a well-known powerful determinant of mortality and poor outcome after intracerebral hemorrhage. Some observations suggest that previous use of antiplatelet agents associates with rapid hematoma enlargement and poor outcome after cerebral hemorrhage. Immediate platelet transfusion for such patients may prevent hematoma growth but also cause thromboembolic complications.

Official Title
-----------------
Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors

Conditions
-----------------
Intracerebral Hemorrhage

Intervention / Treatment
-----------------
* Biological: platelets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being on either aspirin or clopidogrel or a combination of aspirin and dipyridamole acute primary ICH > 17 years admitted within 6 h after onset of ICH ICH score < 4 Exclusion Criteria: other type of ICH than acute primary intracerebral hemorrhage patients who need neurosurgery life expectancy less than 3 months due to comorbid disorders confirmed malignant disease (cancer) confirmed acute myocardial infarction hepatitis and/liver cirrhosis renal failure infectious disease (HIV, endocarditis etc.) current or previous hematologic disease women of childbearing age if pregnant participation in another study within the preceding 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Platelet transfusion | Biological: platelets<br>* Four units of fresh platelets will be infused immediately<br>|
| No Intervention: 2<br>No platelet transfusion | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Score |  | 90 days | 
| Cardiovascular death occurring within the treatment period |  | 90 days | 
| Death due to any cause occurring within the treatment period |  | 90 days | 
| Acute myocardial infarction |  | 90 days | 
| Venous thromboembolism |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intracerebral hemorrhage, Hematoma enlargement, Antiplatelet agent, Platelet transfusion, Outcome