Perioperative Coagulation Management in Cardiac Surgery. - Full Text View

Sponsors and Collaborators:	University Hospital, Limoges Laboratoire français de Fractionnement et de Biotechnologies
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00772239

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

MedlinePlus related topics: Blood Transfusion and Donation Heart Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.

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
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Rotem: Experimental ROTEM: Rotation thromboelastometry	Device: Rotation thromboelastometry (ROTEM) Coagulation measurement
S: Active Comparator 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

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

Locations

France
Service CTCV
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

Responsible Party:	CHU Limoges ( Karine Nubret-Le coniat )
Study ID Numbers:	I07018/ROTEM CTV
Study First Received:	October 13, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00772239
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:

Coagulation Management
Cardiac surgery
Bleeding
Rotem

Study placed in the following topic categories:

Hemorrhage

ClinicalTrials.gov processed this record on January 14, 2009