Perioperative Coagulation Management in Cardiac Surgery. (ROTEM)

This study has been terminated.
Sponsor:
Collaborator:
Laboratoire français de Fractionnement et de Biotechnologies
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00772239
First received: October 13, 2008
Last updated: April 23, 2011
Last verified: April 2011
  Purpose

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 Intervention
Cardiac Surgery
Bleeding
Device: Rotation thromboelastometry (ROTEM)
Procedure: Standard coagulation managment procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Quantity of different blood transfusion [ Time Frame: during cardiac surgery management ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2008
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772239

Locations
France
Service d'Anesthésie réanimation Chirurgicale
Bordeaux, France, 33000
Hôpital Haut Levêque- 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
  More Information

No publications provided

Responsible Party: Karine Nubret-Le coniat, CHU Limoges
ClinicalTrials.gov Identifier: NCT00772239     History of Changes
Other Study ID Numbers: I07018/ROTEM CTV
Study First Received: October 13, 2008
Last Updated: April 23, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 18, 2014