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

June 12, 2008
July 1, 2010
January 2009
July 2014   (final data collection date for primary outcome measure)
Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00699621 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Platelet Transfusion in Acute Intracerebral Hemorrhage
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.
  • 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Intracerebral Hemorrhage
Biological: platelets
Four units of fresh platelets will be infused immediately
  • Active Comparator: 1
    Platelet transfusion
    Intervention: Biological: platelets
  • No Intervention: 2
    No platelet transfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Finland
 
NCT00699621
A-1 EUDRACT 2007-006206-24
Yes
Oulu University Hospital (Matti Hillbom), Oulu University Hospital
University of Oulu
Helsinki University
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
University of Oulu
July 2010

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