Intracerebral Hemorrhage Clinical Trial
Official title:
Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors
- 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | Department of Neurology, Oulu University Hospital | Oulu |
Lead Sponsor | Collaborator |
---|---|
University of Oulu | Helsinki University |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT | 24 hours | No | |
Secondary | Glasgow Outcome Score | 90 days | Yes | |
Secondary | Cardiovascular death occurring within the treatment period | 90 days | Yes | |
Secondary | Death due to any cause occurring within the treatment period | 90 days | Yes | |
Secondary | Acute myocardial infarction | 90 days | Yes | |
Secondary | Venous thromboembolism | 90 days | Yes |
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