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

October 13, 2008
April 23, 2011
October 2008
August 2010   (final data collection date for primary outcome measure)
Quantity of different blood transfusion [ Time Frame: during cardiac surgery management ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00772239 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Perioperative Coagulation Management in Cardiac Surgery.
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Cardiac Surgery
  • Bleeding
  • Device: Rotation thromboelastometry (ROTEM)
    Coagulation measurement
  • Procedure: Standard coagulation managment procedure
    Standard coagulation managment procedure
  • Experimental: Rotem
    ROTEM: Rotation thromboelastometry
    Intervention: Device: Rotation thromboelastometry (ROTEM)
  • Active Comparator: S
    Standard coagulation managment procedure
    Intervention: Procedure: Standard coagulation managment procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
Not Provided
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00772239
I07018/ROTEM CTV
No
Karine Nubret-Le coniat, CHU Limoges
University Hospital, Limoges
Laboratoire français de Fractionnement et de Biotechnologies
Study Chair: Nathalie NATHAN-DENIZOT, MD CHU limoges
University Hospital, Limoges
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP