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Perioperative Coagulation Management in Cardiac Surgery. (ROTEM)

Primary Purpose

Cardiac Surgery, Bleeding

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rotation thromboelastometry (ROTEM)
Standard coagulation managment procedure
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiac Surgery focused on measuring Coagulation Management, Cardiac surgery, Bleeding, Rotem

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale
  • Service d'Anesthésie réanimation Chirurgicale
  • Service Anésthésie
  • Service d'Anesthésie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rotem

S

Arm Description

ROTEM: Rotation thromboelastometry

Standard coagulation managment procedure

Outcomes

Primary Outcome Measures

Quantity of different blood transfusion

Secondary Outcome Measures

Full Information

First Posted
October 13, 2008
Last Updated
April 23, 2011
Sponsor
University Hospital, Limoges
Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
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1. Study Identification

Unique Protocol Identification Number
NCT00772239
Brief Title
Perioperative Coagulation Management in Cardiac Surgery.
Acronym
ROTEM
Official Title
Perioperative Coagulation Management in Cardiac Surgery. Rotem Versus Standard Pratctice. A Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges
Collaborators
Laboratoire français de Fractionnement et de Biotechnologies

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Bleeding
Keywords
Coagulation Management, Cardiac surgery, Bleeding, Rotem

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rotem
Arm Type
Experimental
Arm Description
ROTEM: Rotation thromboelastometry
Arm Title
S
Arm Type
Active Comparator
Arm Description
Standard coagulation managment procedure
Intervention Type
Device
Intervention Name(s)
Rotation thromboelastometry (ROTEM)
Intervention Description
Coagulation measurement
Intervention Type
Procedure
Intervention Name(s)
Standard coagulation managment procedure
Intervention Description
Standard coagulation managment procedure
Primary Outcome Measure Information:
Title
Quantity of different blood transfusion
Time Frame
during cardiac surgery management

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie NATHAN-DENIZOT, MD
Organizational Affiliation
CHU limoges
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Haut Levêque- Service d'Anesthésie réanimation Chirurgicale
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Service d'Anesthésie réanimation Chirurgicale
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Service Anésthésie
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Service d'Anesthésie
City
Limoges
ZIP/Postal Code
87000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Perioperative Coagulation Management in Cardiac Surgery.

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