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Platelet Transfusion in Acute Intracerebral Hemorrhage

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00699621
Enrollment
100
Registered
2008-06-18
Start date
2009-01-31
Completion date
2014-12-31
Last updated
2010-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

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

BIOLOGICALplatelets

Four units of fresh platelets will be infused immediately

Sponsors

University of Helsinki
CollaboratorOTHER
University of Oulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frame
Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT24 hours

Secondary

MeasureTime frame
Glasgow Outcome Score90 days
Cardiovascular death occurring within the treatment period90 days
Death due to any cause occurring within the treatment period90 days
Acute myocardial infarction90 days
Venous thromboembolism90 days

Countries

Finland

Contacts

Primary ContactMatti E Hillbom, MD, PhD
matti.hillbom@oulu.fi358-8-315-4518
Backup ContactJuha T Huhtakangas, MD
juha.huhtakangas@ppshp.fi358-8-315-4032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026