Perioperative Coagulation Management in Cardiac Surgery.
NCT ID: NCT00772239
Last Updated: 2011-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
100 participants
INTERVENTIONAL
2008-10-31
Brief Summary
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The haemorrhagic is related to the need to use high doses of anticoagulants to prevent thrombosis of blood . Moreover, this type of surgery is platelets and coagulation factors consumming despite conducting a thorough anticoagulation.
All these changes contribute to increase the need for transfusions during heart surgery.
The main objective of this study is to compare the need for transfusions in patients suffering from bleeding complications after cardiac surgery with a therapeutic algorithm based on the use of ROTEM ® versus standard tests based solely on standard laboratory tests.
100 pateinst (50 in each arm) should be included in this trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Rotem
ROTEM: Rotation thromboelastometry
Rotation thromboelastometry (ROTEM)
Coagulation measurement
S
Standard coagulation managment procedure
Standard coagulation managment procedure
Standard coagulation managment procedure
Interventions
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Rotation thromboelastometry (ROTEM)
Coagulation measurement
Standard coagulation managment procedure
Standard coagulation managment procedure
Eligibility Criteria
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Inclusion Criteria
* Cardiac surgery or heart transplantation with abnormal bleeding regardless the etiology
* given informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Laboratoire français de Fractionnement et de Biotechnologies
INDUSTRY
University Hospital, Limoges
OTHER
Responsible Party
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CHU Limoges
Principal Investigators
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Nathalie NATHAN-DENIZOT, MD
Role: STUDY_CHAIR
CHU limoges
Locations
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Service Anésthésie
Limoges, Limoges, France
Service d'Anesthésie
Limoges, Limoges, France
Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale
Bordeaux, , France
Service d'Anesthésie réanimation Chirurgicale
Bordeaux, , France
Countries
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Other Identifiers
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I07018/ROTEM CTV
Identifier Type: -
Identifier Source: org_study_id
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