Perioperative Coagulation Management in Cardiac Surgery.

NCT ID: NCT00772239

Last Updated: 2011-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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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

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Conditions

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Cardiac Surgery Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Rotem

ROTEM: Rotation thromboelastometry

Group Type EXPERIMENTAL

Rotation thromboelastometry (ROTEM)

Intervention Type DEVICE

Coagulation measurement

S

Standard coagulation managment procedure

Group Type ACTIVE_COMPARATOR

Standard coagulation managment procedure

Intervention Type PROCEDURE

Standard coagulation managment procedure

Interventions

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Rotation thromboelastometry (ROTEM)

Coagulation measurement

Intervention Type DEVICE

Standard coagulation managment procedure

Standard coagulation managment procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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CHU Limoges

Principal Investigators

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Nathalie NATHAN-DENIZOT, MD

Role: STUDY_CHAIR

CHU limoges

Locations

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Service Anésthésie

Limoges, Limoges, France

Site Status

Service d'Anesthésie

Limoges, Limoges, France

Site Status

Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale

Bordeaux, , France

Site Status

Service d'Anesthésie réanimation Chirurgicale

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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I07018/ROTEM CTV

Identifier Type: -

Identifier Source: org_study_id

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