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

Completed

• Conditions: Cardiac Surgery; Coagulopathy; Cardiopulmonary Bypass
• Interventions: Diagnostic Test: In vitro medical diagnostic device TEG6s® Platelet Mapping

• Registration Number: NCT06230640
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-01-30
• Study Start: 2024-07-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-10
• Study Completion: 2025-03-10
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cardiac surgery with cardiopulmonary bypass	In vitro medical diagnostic device TEG6s® Platelet Mapping	Any subject undergoing cardiac surgery with cardiopulmonary bypass and at high risk of bleeding and transfusion.

Primary Outcome Measures

Name	Time	Method
Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass.	After anesthetic induction; 30 min before aortic declamping and 5min after antagonization	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.

Secondary Outcome Measures

Name	Time	Method
Post-operative bleeding over the first 2 hours	during the 2 hours post-surgery	Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)
Change in maximum amplitude in the presence of fibrinogen activator (MA ActF) of TEG 6S platelet mapping® during CPB.	After anesthetic induction; 30 min before aortic declamping	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.
Maximum amplitude change in the presence of arachidonic acid (MA AA) in TEG 6S platelet mapping® during CPB.	After anesthetic induction; 30 min before aortic declamping	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.
Correlation between the R HKH time of TEG 6S platelet mapping® and the R CKH of TEG 6S citrated®.	After anesthetic induction; 30 min before aortic declamping and 5min after antagonization	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.
Post-operative bleeding over 12 hours in intensive care	during the 12 hours post-surgery	Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)
Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB.	After anesthetic induction; 30 min before aortic declamping	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.
Maximum amplitude change in the presence of P2Y12 receptor activating ADP (MA ADP) of TEG 6S platelet mapping® during CPB.	After anesthetic induction; 30 min before aortic declamping	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.

Trial Locations

Locations (1)

Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier; 🇫🇷 Montpellier, France