Perioperative Coagulation Management in Cardiac Surgery.

Not Applicable

Terminated

• Conditions: Cardiac Surgery; Bleeding
• Interventions: Device: Rotation thromboelastometry (ROTEM); Procedure: Standard coagulation managment procedure

• Registration Number: NCT00772239
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-13
• Study First Posted: 2008-10-15
• Primary Completion: 2010-08
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-23
• Last Update Posted: 2011-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotem	Rotation thromboelastometry (ROTEM)	ROTEM: Rotation thromboelastometry
S	Standard coagulation managment procedure	Standard coagulation managment procedure

Primary Outcome Measures

Name	Time	Method
Quantity of different blood transfusion	during cardiac surgery management

Trial Locations

Locations (4)

Service Anésthésie; 🇫🇷 Limoges, France

Service d'Anesthésie réanimation Chirurgicale; 🇫🇷 Bordeaux, France

Service d'Anesthésie; 🇫🇷 Limoges, France

Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale; 🇫🇷 Bordeaux, France