Evaluation of TEG 6S PM® During Cardiopulmonary Bypass to Detect Postoperative Biological Coagulopathy (PREDIPOC)

Evaluation of TEG 6S Platelet Mapping® During Cardiopulmonary Bypass for Cardiac Surgery to Detect Postoperative Biological Coagulopathy

This is a prospective study to evaluate the predictive value of the TEG 6s platelet mapping® (TEG 6s® PM) performed during cardiopulmonary bypass (CPB) in the prediction of biological coagulopathy (determined by TEG 6S global hemostasis®), in cardiac surgery with high risk of bleeding.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Coagulopathy
• Intervention / Treatment: Diagnostic test: In vitro medical diagnostic device TEG6s® Platelet Mapping

Detailed Description

The aim of this prospective study is to evaluate the predictive value of the R time (HKH) given by the TEG 6s platelet mapping® performed during the CPB in the prediction of postoperative biological coagulopathy.

In order to evaluate its interest and to validate its use during cardiac surgery with high bleeding risk under CPB, we plan to compare 2 thromboelastographic tests in the detection of biological coagulopathy: TEG 6S citrated® (reference) and TEG 6S platelet mapping®. Biological coagulopathy is defined by a kaolin-heparinase assay coagulation/reaction time (CKH R) value of 7 min on TEG 6S citrated® (fibrinogen impairment defined by a Comparison of functional fibrinogen Maximal Amplitude (CFF MA) < 20 mm, and CKH MA impairment (< 60 mm), in accordance with established laboratory standard values.

• Study Type: Observational
• Enrollment (Estimated): 59

Contacts and Locations

• Study Contact: Name: Benjamin Bourdois, MD; Phone Number: +33 04.67.33.59.58; Email: b-bourdois@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier
    • Contact: Benjamin Bourdois, Dr; Phone Number: +334.67.33.59.58; Email: b-bourdois@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Any subject undergoing cardiac surgery with cardiopulmonary bypass circulation and at high risk of bleeding and transfusion.

Description

Inclusion Criteria:

• 18 years old or older
• Cardiac surgery under cardiopulmonary bypass with high risk of bleeding defined among:
• CPB with circulatory arrest
• cardiac transplantation
• Redo surgery
• infective endocarditis
• predicted duration of CBP ≥ 120 min
• High transfusion risk defined by a Trust predictive score ≥ 3 (Transfusion Risk Understanding Scoring Tool)

Exclusion Criteria:

• Patient with heparin allergy or heparin-induced thrombocytopenia
• Use of direct oral anticoagulant (DAA) with anti-factor X activity (Apixaban, Rivaroxaban) < 72h, even if antagonized
• Patient on partially or fully antagonized VKAs
• Opposition to participation after a period of reflection
• Adult protected by law (guardianship, curatorship)
• Person deprived of liberty
• Person participating in another study with an exclusion period still in progress
• Patient not affiliated to a social security scheme or not benefiting from such a scheme
• Pregnant or breast-feeding woman

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

cardiac surgery with cardiopulmonary bypass; Any subject undergoing cardiac surgery with cardiopulmonary bypass and at high risk of bleeding and transfusion.

Diagnostic test: In vitro medical diagnostic device TEG6s® Platelet Mapping; Preoperative period: Pre-operative blood sampling, according to the usual practices of the unit before surgery; Collection of the patient's usual demographic characteristics per operative period : After anesthetic induction:a TEG6S platelet mapping® sampled from the arterial catheter routinely placed after anesthetic induction; During the CPB, 30 min before aortic declamping: performing TEG 6S platelet mapping® (heparinized tube); 5 min after heparin antagonization by protamine, after the weaning of the bypass, and before any transfusion: performing a TEG 6S citrate® (citrated tube) Post-operative period (resuscitation): • postoperative bleeding at 2 hours and during the first 12 hours.; Other Names: Comparison between TEG 6S platelet mapping® and TEG 6S global hemostasis Assessment of platelet inhibition rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass.	The measurement of the R time (coagulation time in minutes) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory and using the TEG 6S platelet mapping® and global hemostasis® cartridge.	After anesthetic induction; 30 min before aortic declamping and 5min after antagonization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB.	The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.	After anesthetic induction; 30 min before aortic declamping
Change in maximum amplitude in the presence of fibrinogen activator (MA ActF) of TEG 6S platelet mapping® during CPB.	The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.	After anesthetic induction; 30 min before aortic declamping
Maximum amplitude change in the presence of arachidonic acid (MA AA) in TEG 6S platelet mapping® during CPB.	The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.	After anesthetic induction; 30 min before aortic declamping
Maximum amplitude change in the presence of P2Y12 receptor activating ADP (MA ADP) of TEG 6S platelet mapping® during CPB.	The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.	After anesthetic induction; 30 min before aortic declamping
Correlation between the R HKH time of TEG 6S platelet mapping® and the R CKH of TEG 6S citrated®.	The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.	After anesthetic induction; 30 min before aortic declamping and 5min after antagonization
Post-operative bleeding over the first 2 hours	Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)	during the 2 hours post-surgery
Post-operative bleeding over 12 hours in intensive care	Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)	during the 12 hours post-surgery

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Benjamin Bourdois, MD, University Hospital, Montpellier

Publications and helpful links

General Publications

• Yamamoto Y, Sato Y, Takahashi M, Yamamoto H, Echizen M, Uchida T. TEG6s Platelet Mapping assay for the estimation of plasma fibrinogen concentration during cardiovascular surgery: a single-center prospective observational study. J Anesth. 2022 Feb;36(1):79-88. doi: 10.1007/s00540-021-03009-4. Epub 2021 Oct 13.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cardiac surgery; cardiopulmonary bypass; Coagulopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Coagulants; Hemostatics
• Other Study ID Numbers: RECHMPL23_0167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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