Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.

Perioperative Coagulation Management in Cardiac Surgery.

Sponsors

Lead sponsor: University Hospital, Limoges

Collaborator: Laboratoire français de Fractionnement et de Biotechnologies

Source 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.

Overall Status Terminated
Start Date October 2008
Primary Completion Date August 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Quantity of different blood transfusion during cardiac surgery management
Enrollment 100
Condition
Intervention

Intervention type: Device

Intervention name: Rotation thromboelastometry (ROTEM)

Description: Coagulation measurement

Arm group label: Rotem

Intervention type: Procedure

Intervention name: Standard coagulation managment procedure

Description: Standard coagulation managment procedure

Arm group label: S

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Nathalie NATHAN-DENIZOT, MD Study Chair CHU limoges
Location
facility
Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale | Bordeaux, 33000, France
Service d'Anesthésie réanimation Chirurgicale | Bordeaux, 33000, France
Service Anésthésie | Limoges, 87000, France
Service d'Anesthésie | Limoges, 87000, France
Location Countries

France

Verification Date

April 2011

Responsible Party

Name title: Karine Nubret-Le coniat

Organization: CHU Limoges

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Rotem

Arm group type: Experimental

Description: ROTEM: Rotation thromboelastometry

Arm group label: S

Arm group type: Active Comparator

Description: Standard coagulation managment procedure

Acronym ROTEM
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov