Perioperative Coagulation Management in Cardiac Surgery. | NCT00772239

Studies
Perioperative Coagulation Management in Cardiac Surgery.

NCT00772239

Sponsor

University Hospital, Limoges

Status

Terminated

Last Update Posted

Apr 26, 2011Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Cardiac Surgery
Bleeding

Interventions

Rotation thromboelastometry (ROTEM)
Standard coagulation managment procedure

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Aug 2010Actual

Completion Date

Not provided

First Submitted Date

Oct 13, 2008

First Submission Date that Met QC Criteria

Oct 13, 2008

First Posted Date

Oct 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2011

Last Update Posted Date

Apr 26, 2011Estimated

Name	Class
Laboratoire français de Fractionnement et de Biotechnologies	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rotem	Experimental	ROTEM: Rotation thromboelastometry	Device: Rotation thromboelastometry (ROTEM)
S	Active Comparator	Standard coagulation managment procedure	Procedure: Standard coagulation managment procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rotation thromboelastometry (ROTEM)	Device	Coagulation measurement	Rotem

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nathalie NATHAN-DENIZOT, MD	CHU limoges	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Anésthésie		Limoges	Limoges	87000	France
Service d'Anesthésie

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided