Perioperative Coagulation Management in Cardiac Surgery. (ROTEM)

University of Limoges (UL)

Status: Terminated

Conditions: Cardiac Surgery; Bleeding

Treatments: Procedure: Standard coagulation managment procedure; Device: Rotation thromboelastometry (ROTEM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00772239

I07018/ROTEM CTV

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rotem

Experimental group

Description:

ROTEM: Rotation thromboelastometry

Treatment:

Device: Rotation thromboelastometry (ROTEM)

S

Active Comparator group

Description:

Standard coagulation managment procedure

Treatment:

Procedure: Standard coagulation managment procedure