- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00772239
Perioperative Coagulation Management in Cardiac Surgery. (ROTEM)
Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33000
- Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale
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Bordeaux, France, 33000
- Service d'Anesthésie réanimation Chirurgicale
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Limoges, France, 87000
- Service Anesthésie
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Limoges, France, 87000
- Service d'Anesthésie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults> 18 years
- Cardiac surgery or heart transplantation with abnormal bleeding regardless the etiology
- given informed consent
Exclusion Criteria:
- Patient supported by a pre or postoperative circulatory technical assistance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rotem
ROTEM: Rotation thromboelastometry
|
Coagulation measurement
|
Active Comparator: S
Standard coagulation managment procedure
|
Standard coagulation managment procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quantity of different blood transfusion
Time Frame: during cardiac surgery management
|
during cardiac surgery management
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nathalie NATHAN-DENIZOT, MD, CHU Limoges
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I07018/ROTEM CTV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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