Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis.

NCT ID: NCT06550505

Last Updated: 2024-08-13

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

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2022-03-23

Brief Summary

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Evaluation and following of a protocol using viscoelastic test for the management of high risk patients in cardiac surgery

Detailed Description

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Haemorragy is a frequent issue in cardiac surgery due to multiple contributing factors. Excessive bleeding as well as transfusion are associated with increased morbidity and mortality.

Haemostatic blood products (Fibrinogen, fresh frozen plasma, platelets) transfusion had historically been guided by routine coagulation tests (aPTT, PT, platelets and fibrinogen). However, the delay (Up to 60 minutes) often leads to an empirical use of blood products in a context where clinical judgment is unreliable due to the multiples mechanisms contributing to haemostatic failure.

Using viscoelastic tests (VET) in this context has several advantages :

* A quicker response (with first results from 10 minutes)
* An overall evaluation of haemostatic from the clot formation to its dissolution.

The use of VET has mainly been evaluated in cardiac surgery, with several recent meta-analysis : The use of transfusion algorithms based on VET is associated with less transfusions of red blood cell concentrates, plasma and platelets and also with less mortality, less re-interventions due to excessive bleeding and less post operative renal failure.

These data led the international society for the study of hemostasis and thrombosis (ISTH) to recommend their use of VET in cardiac surgery. In France, the proposals of the peri operative hemostatis group of interest (GIHP) also support their use, specifying that there is no unique consensual algorithm.

Considering this, the investigator established a transfusion algorithm based on the Quantra, a viscoelastic device using sonorrheometry, to guide transfusion in high-risk of bleeding cardiac surgery patients.

Conditions

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Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult patients
* Elective or non-elective high risk of bleeding heart surgery
* Non-opposition

Exclusion Criteria

* Pregnant women
* Age \< 18 years
* Patients under guardianship
* Opposition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU BREST, Hôpital de la Cavale Blanche

Brest, , France

Site Status

Countries

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France

Other Identifiers

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29BRC21.0017 - ELASTICC

Identifier Type: -

Identifier Source: org_study_id

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