Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2009-01-31
2014-12-31
Brief Summary
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* 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
Platelet transfusion
platelets
Four units of fresh platelets will be infused immediately
2
No platelet transfusion
No interventions assigned to this group
Interventions
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platelets
Four units of fresh platelets will be infused immediately
Eligibility Criteria
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Inclusion Criteria
* acute primary ICH
* \> 17 years
* admitted within 6 h after onset of ICH
* ICH score \< 4
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Helsinki
OTHER
University of Oulu
OTHER
Responsible Party
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Oulu University Hospital
Principal Investigators
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Matti E Hillbom, MD, PhD
Role: STUDY_CHAIR
Oulu University Central Hospital, Department of Neurology
Seppo S Juvela, MD, PhD
Role: STUDY_DIRECTOR
Turku University Central Hospital, Department of Neurosurgery
Lauri Soinne, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital, Department of Neurology
Olli Häppölä, MD, PhD
Role: STUDY_DIRECTOR
Helsinki University Central Hospital
Aimo Rissanen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Keski-Suomen Keskussairaala
Locations
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Department of Neurology, Oulu University Hospital
Oulu, , Finland
Countries
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Central Contacts
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Facility Contacts
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References
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Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
Other Identifiers
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A-1 EUDRACT 2007-006206-24
Identifier Type: -
Identifier Source: org_study_id
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