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Perioperative Coagulation Management in Cardiac Surgery. (ROTEM)

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ClinicalTrials.gov Identifier: NCT00772239
Recruitment Status : Terminated
First Posted : October 15, 2008
Last Update Posted : April 26, 2011
Sponsor:
Collaborator:
Laboratoire français de Fractionnement et de Biotechnologies
Information provided by:
University Hospital, Limoges

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiac Surgery Bleeding Device: Rotation thromboelastometry (ROTEM) Procedure: Standard coagulation managment procedure Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.
Study Start Date : October 2008
Actual Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Rotem
ROTEM: Rotation thromboelastometry
Device: Rotation thromboelastometry (ROTEM)
Coagulation measurement

Active Comparator: S
Standard coagulation managment procedure
Procedure: Standard coagulation managment procedure
Standard coagulation managment procedure




Primary Outcome Measures :
  1. Quantity of different blood transfusion [ Time Frame: during cardiac surgery management ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT00772239


Locations
France
Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale
Bordeaux, France, 33000
Service d'Anesthésie réanimation Chirurgicale
Bordeaux, France, 33000
Service Anésthésie
Limoges, France, 87000
Service d'Anesthésie
Limoges, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
Study Chair: Nathalie NATHAN-DENIZOT, MD CHU limoges

Responsible Party: Karine Nubret-Le coniat, CHU Limoges
ClinicalTrials.gov Identifier: NCT00772239     History of Changes
Other Study ID Numbers: I07018/ROTEM CTV
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011

Keywords provided by University Hospital, Limoges:
Coagulation Management
Cardiac surgery
Bleeding
Rotem

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes