Platelet Transfusion in Acute Intracerebral Hemorrhage

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose
  • 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 Intervention
Intracerebral Hemorrhage
Biological: platelets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors

Resource links provided by NLM:


Further study details as provided by University of Oulu:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Platelet transfusion
Biological: platelets
Four units of fresh platelets will be infused immediately
No Intervention: 2
No platelet transfusion

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699621

Contacts
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
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
Helsinki University
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 Hospital
Principal Investigator: Aimo Rissanen, MD, PhD Keski-Suomen Keskussairaala
  More Information

No publications provided

Responsible Party: Oulu University Hospital (Matti Hillbom), Oulu University Hospital
ClinicalTrials.gov Identifier: NCT00699621     History of Changes
Other Study ID Numbers: A-1 EUDRACT 2007-006206-24
Study First Received: June 12, 2008
Last Updated: July 1, 2010
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:
Intracerebral hemorrhage
Hematoma enlargement
Antiplatelet agent
Platelet transfusion
Outcome

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014