Platelet Transfusion in Acute Intracerebral Hemorrhage

University of Oulu

Status: Unknown

Conditions: Intracerebral Hemorrhage

Treatments: Biological: platelets

Study type: Interventional

Funder types: Other

Identifiers

NCT00699621

A-1 EUDRACT 2007-006206-24

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Active Comparator group

Description:

Platelet transfusion

Treatment:

Biological: platelets

2

No Intervention group

Description:

No platelet transfusion