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Trial record 1 of 1 for:    NCT00699621
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Platelet Transfusion in Acute Intracerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT00699621
Recruitment Status : Unknown
Verified July 2010 by University of Oulu.
Recruitment status was:  Recruiting
First Posted : June 18, 2008
Last Update Posted : July 2, 2010
Sponsor:
Collaborator:
University of Helsinki
Information provided by:
University of Oulu

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Biological: platelets Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors
Study Start Date : January 2009
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Glasgow Outcome Score [ Time Frame: 90 days ]
  2. Cardiovascular death occurring within the treatment period [ Time Frame: 90 days ]
  3. Death due to any cause occurring within the treatment period [ Time Frame: 90 days ]
  4. Acute myocardial infarction [ Time Frame: 90 days ]
  5. Venous thromboembolism [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699621


Contacts
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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

Locations
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Finland
Department of Neurology, Oulu University Hospital Recruiting
Oulu, Finland, 90029 OYS
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   
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         
Sponsors and Collaborators
University of Oulu
University of Helsinki
Investigators
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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
More Information
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Responsible Party: Oulu University Hospital (Matti Hillbom), Oulu University Hospital
ClinicalTrials.gov Identifier: NCT00699621    
Other Study ID Numbers: A-1 EUDRACT 2007-006206-24
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: July 2, 2010
Last Verified: July 2010
Keywords provided by University of Oulu:
Intracerebral hemorrhage
Hematoma enlargement
Antiplatelet agent
Platelet transfusion
Outcome
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases