Clinical trial NCT00699621: Platelet Transfusion in Acute Intracerebral Hemorrhage
Official title: Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral hemorrhage
Hematoma enlargement
Antiplatelet agent
Platelet transfusion
Outcome
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2008-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT
timeFrame: 24 hours
Secondary outcomes:
measure: Glasgow Outcome Score
timeFrame: 90 days
measure: Cardiovascular death occurring within the treatment period
timeFrame: 90 days
measure: Death due to any cause occurring within the treatment period
timeFrame: 90 days
measure: Acute myocardial infarction
timeFrame: 90 days
measure: Venous thromboembolism
timeFrame: 90 days
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Department of Neurology, Oulu University Hospital
Study officials:
affiliation: Oulu University Central Hospital, Department of Neurology
name: Matti E Hillbom, MD, PhD
role: STUDY_CHAIR
affiliation: Turku University Central Hospital, Department of Neurosurgery
name: Seppo S Juvela, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital, Department of Neurology
name: Lauri Soinne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Olli Häppölä, MD, PhD
role: STUDY_DIRECTOR
affiliation: Keski-Suomen Keskussairaala
name: Aimo Rissanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: