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NCT00772239 Clinical Trial

Perioperative Coagulation Management in Cardiac Surgery.

Cardiac Surgery Clinical Trial

— ROTEM  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00772239
Other study ID # I07018/ROTEM CTV
Secondary ID
Status Terminated
Phase N/A
First received October 13, 2008
Last updated April 23, 2011
Start date October 2008

Study information
Verified date April 2011
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Device:
• Rotation thromboelastometry (ROTEM)
Coagulation measurement
Procedure:
• Standard coagulation managment procedure
Standard coagulation managment procedure

Locations
Country Name City State
France Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale Bordeaux
France Service d'Anesthésie réanimation Chirurgicale Bordeaux
France Service Anésthésie Limoges
France Service d'Anesthésie Limoges

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Limoges Laboratoire français de Fractionnement et de Biotechnologies

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantity of different blood transfusion during cardiac surgery management No
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