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

Evaluation and Follow-up of a Protocol for the Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis.

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHRU BREST, Hôpital de la Cavale Blanche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients. Elective or non-elective heart surgery. High risk of bleeding.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fresh frozen plasma transfusion	Proportion of patients transfused with fresh frozen plasma 48 hours after the surgery.	48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): March 20, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 29BRC21.0017 - ELASTICC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No