Platelet Transfusion in Acute Intracerebral Hemorrhage
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
- 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|
- 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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: 1
Four units of fresh platelets will be infused immediately
No Intervention: 2
No platelet transfusion
- Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT [ Time Frame: 24 hours ]
- Glasgow Outcome Score [ Time Frame: 90 days ]
- Cardiovascular death occurring within the treatment period [ Time Frame: 90 days ]
- Death due to any cause occurring within the treatment period [ Time Frame: 90 days ]
- Acute myocardial infarction [ Time Frame: 90 days ]
- Venous thromboembolism [ Time Frame: 90 days ]
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
|Contact: Matti E Hillbom, MD, PhDfirstname.lastname@example.org|
|Contact: Juha T Huhtakangas, MDemail@example.com|
|Department of Neurology, Oulu University Hospital||Recruiting|
|Oulu, Finland, 90029 OYS|
|Contact: Matti E Hillbom, MD, PhD 358-8-315-4518 firstname.lastname@example.org|
|Contact: Juha T Huhtakangas, MD 358-8-315-4032 email@example.com|
|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|
|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|