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

NCT ID: NCT06230640

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-03-10

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.

Conditions

Coagulopathy; Cardiopulmonary Bypass; Cardiac Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

cardiac surgery with cardiopulmonary bypass

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

In vitro medical diagnostic device TEG6s® Platelet Mapping

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Comparison between TEG 6S platelet mapping® and TEG 6S global hemostasis Assessment of platelet inhibition rate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Bourdois, MD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 34643817 (View on PubMed)

Other Identifiers

RECHMPL23_0167

Identifier Type: -

Identifier Source: org_study_id