Intracerebral Hemorrhage
Conditions
Keywords
Intracerebral hemorrhage, Hematoma enlargement, Antiplatelet agent, Platelet transfusion, Outcome
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.
Interventions
Four units of fresh platelets will be infused immediately
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT | 24 hours |
Secondary
| Measure | 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 |
Countries
Finland