Platelet Transfusion in Acute Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00699621
• Other study ID #: A-1 EUDRACT 2007-006206-24
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2008
• Last updated: July 1, 2010
• Start date: January 2009
• Est. completion date: December 2014

Study information

• Verified date: July 2010
• Source: University of Oulu
• Contact: Matti E Hillbom, MD, PhD
• Phone: 358-8-315-4518
• Email: matti.hillbom[@]oulu.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Biological:
• platelets
Four units of fresh platelets will be infused immediately

Locations

Country	Name	City	State
Finland	Department of Neurology, Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

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