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

Completed

• Conditions: Cardiac Surgery

• Registration Number: NCT06550505
• Lead Sponsor: University Hospital, Brest

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2021-11-30
• Primary Completion: 2022-03-20
• Study Completion: 2022-03-23
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• Pregnant women
• Age < 18 years
• Patients under guardianship
• Opposition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fresh frozen plasma transfusion	48 hours	Proportion of patients transfused with fresh frozen plasma 48 hours after the surgery.

Trial Locations

Locations (1)

CHRU BREST, Hôpital de la Cavale Blanche; 🇫🇷 Brest, France