Perioperative Coagulation Management in Cardiac Surgery.
NCT00772239 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2011-04-26
Summary
Cardiac surgery is bleeding requiring transfusion surgery .
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.
Conditions
- Cardiac Surgery
- Bleeding
Interventions
- DEVICE
-
Rotation thromboelastometry (ROTEM)
Coagulation measurement
- PROCEDURE
-
Standard coagulation managment procedure
Standard coagulation managment procedure
Sponsors & Collaborators
-
Laboratoire français de Fractionnement et de Biotechnologies
collaborator INDUSTRY -
University Hospital, Limoges
lead OTHER
Principal Investigators
-
Nathalie NATHAN-DENIZOT, MD · CHU limoges
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2010-08-31
Countries
- France
Study Locations
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