Platelet Transfusion in Acute Intracerebral Hemorrhage

NCT ID: NCT00699621

Last Updated: 2010-07-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-12-31

Brief Summary

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* 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

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* 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.

Conditions

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Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Platelet transfusion

Group Type ACTIVE_COMPARATOR

platelets

Intervention Type BIOLOGICAL

Four units of fresh platelets will be infused immediately

2

No platelet transfusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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platelets

Four units of fresh platelets will be infused immediately

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Matti E Hillbom, MD, PhD

Role: CONTACT

358-8-315-4518

Juha T Huhtakangas, MD

Role: CONTACT

358-8-315-4032

Facility Contacts

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Matti E Hillbom, MD, PhD

Role: primary

358-8-315-4518

Juha T Huhtakangas, MD

Role: backup

358-8-315-4032

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.

Reference Type DERIVED
PMID: 37870112 (View on PubMed)

Other Identifiers

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A-1 EUDRACT 2007-006206-24

Identifier Type: -

Identifier Source: org_study_id

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