Platelet Transfusion in Acute Intracerebral Hemorrhage

Not Applicable

• Conditions: Intracerebral Hemorrhage
• Interventions: Biological: platelets

• Registration Number: NCT00699621
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Study Start: 2009-01
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-01
• Last Update Posted: 2010-07-02
• Primary Completion: 2014-07
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	platelets	Platelet transfusion

Primary Outcome Measures

Name	Time	Method
Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT	24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Neurology, Oulu University Hospital; 🇫🇮 Oulu, Finland