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

NCT06230640 | Completed

• 1 other identifier: RECHMPL23_0167
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulopathy; Cardiopulmonary Bypass; Cardiac Surgery

Keywords

Coagulopathy; cardiac surgery; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB.

  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.

  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.

  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.

  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®.

  After anesthetic induction; 30 min before aortic declamping and 5min after antagonization

Study Arms (1)

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

Interventions

In vitro medical diagnostic device TEG6s® Platelet Mapping 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.

Also known as: Comparison between TEG 6S platelet mapping® and TEG 6S global hemostasis Assessment of platelet inhibition rate

cardiac surgery with cardiopulmonary bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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
• Patient not affiliated to a social security scheme or not benefiting from such a scheme
• Pregnant or breast-feeding woman

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

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

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 34643817 RESULT

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Benjamin Bourdois, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: July 1, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)