Platelet Transfusion in Acute Intracerebral Hemorrhage

This study is currently recruiting participants.

Verified July 2010 by University of Oulu

Sponsor:

Collaborator:

Helsinki University

Information provided by:

University of Oulu

ClinicalTrials.gov Identifier:

NCT00699621

First received: June 12, 2008

Last updated: July 1, 2010

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 12, 2008

Last Updated Date

July 1, 2010

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00699621 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Glasgow Outcome Score [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Cardiovascular death occurring within the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Death due to any cause occurring within the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Acute myocardial infarction [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Venous thromboembolism [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Platelet Transfusion in Acute Intracerebral Hemorrhage

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Intracerebral Hemorrhage

Intervention ^ICMJE

Biological: platelets

Four units of fresh platelets will be infused immediately

Study Arm (s)

Active Comparator: 1
Platelet transfusion

Intervention: Biological: platelets
No Intervention: 2
No platelet transfusion

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

December 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Matti E Hillbom, MD, PhD	358-8-315-4518	matti.hillbom@oulu.fi
Contact: Juha T Huhtakangas, MD	358-8-315-4032	juha.huhtakangas@ppshp.fi

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00699621

Other Study ID Numbers ^ICMJE

A-1 EUDRACT 2007-006206-24

Has Data Monitoring Committee

Yes

Responsible Party

Oulu University Hospital (Matti Hillbom), Oulu University Hospital

Study Sponsor ^ICMJE

University of Oulu

Collaborators ^ICMJE

Helsinki University

Investigators ^ICMJE

Study Chair:	Matti E Hillbom, MD, PhD	Oulu University Central Hospital, Department of Neurology
Study Director:	Seppo S Juvela, MD, PhD	Turku University Central Hospital, Department of Neurosurgery
Principal Investigator:	Lauri Soinne, MD, PhD	Helsinki University Central Hospital, Department of Neurology
Study Director:	Olli Häppölä, MD, PhD	Helsinki University Hospital
Principal Investigator:	Aimo Rissanen, MD, PhD	Keski-Suomen Keskussairaala

Information Provided By

University of Oulu

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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