Platelet Transfusion in Acute Intracerebral Hemorrhage

July 1, 2010 updated by: University of Oulu

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

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90029 OYS
        • Recruiting
        • Department of Neurology, Oulu University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juha T Huhtakangas, MD
        • Sub-Investigator:
          • Tarja T Haapaniemi, MD, PhD
        • Sub-Investigator:
          • Sami T Tetri, MD
        • Sub-Investigator:
          • Michaela Bode, MD, PhD
        • Sub-Investigator:
          • Pertti Saloheimo, MD, PhD
        • Sub-Investigator:
          • Eeva-Riitta Savolainen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Platelet transfusion
Biological: platelets
Four units of fresh platelets will be infused immediately
No Intervention: 2
No platelet transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Glasgow Outcome Score
Time Frame: 90 days
90 days
Cardiovascular death occurring within the treatment period
Time Frame: 90 days
90 days
Death due to any cause occurring within the treatment period
Time Frame: 90 days
90 days
Acute myocardial infarction
Time Frame: 90 days
90 days
Venous thromboembolism
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

University of Helsinki

Investigators

  • 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 Central Hospital
  • Principal Investigator: Aimo Rissanen, MD, PhD, Keski-Suomen Keskussairaala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 2, 2010

Last Update Submitted That Met QC Criteria

July 1, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-1 EUDRACT 2007-006206-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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