Perioperative Coagulation Management in Cardiac Surgery. (ROTEM)

April 23, 2011 updated by: University Hospital, Limoges

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale
      • Bordeaux, France, 33000
        • Service d'Anesthésie réanimation Chirurgicale
      • Limoges, France, 87000
        • Service Anesthésie
      • Limoges, France, 87000
        • Service d'Anesthésie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotem
ROTEM: Rotation thromboelastometry
Device: Rotation thromboelastometry (ROTEM)
Coagulation measurement
Active Comparator: S
Standard coagulation managment procedure
Procedure: Standard coagulation managment procedure
Standard coagulation managment procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantity of different blood transfusion
Time Frame: during cardiac surgery management
during cardiac surgery management

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Collaborators

Laboratoire français de Fractionnement et de Biotechnologies

Investigators

  • Study Chair: Nathalie NATHAN-DENIZOT, MD, CHU Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 13, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

April 26, 2011

Last Update Submitted That Met QC Criteria

April 23, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I07018/ROTEM CTV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe