Clinical trial NCT06230640: Evaluation of TEG 6S PM® During Cardiopulmonary Bypass to Detect Postoperative Biological Coagulopathy
Official title: Evaluation of TEG 6S Platelet Mapping® During Cardiopulmonary Bypass for Cardiac Surgery to Detect Postoperative Biological Coagulopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulopathy
Cardiopulmonary Bypass
Cardiac Surgery
Keywords: Coagulopathy
cardiac surgery
cardiopulmonary bypass
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject undergoing cardiac surgery with cardiopulmonary bypass circulation and at high risk of bleeding and transfusion.

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.

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

Primary outcomes:
measure: Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass.
timeFrame: After anesthetic induction; 30 min before aortic declamping and 5min after antagonization
Secondary outcomes:
measure: Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB.
timeFrame: After anesthetic induction; 30 min before aortic declamping
measure: Change in maximum amplitude in the presence of fibrinogen activator (MA ActF) of TEG 6S platelet mapping® during CPB.
timeFrame: After anesthetic induction; 30 min before aortic declamping
measure: Maximum amplitude change in the presence of arachidonic acid (MA AA) in TEG 6S platelet mapping® during CPB.
timeFrame: After anesthetic induction; 30 min before aortic declamping
measure: Maximum amplitude change in the presence of P2Y12 receptor activating ADP (MA ADP) of TEG 6S platelet mapping® during CPB.
timeFrame: After anesthetic induction; 30 min before aortic declamping
measure: Correlation between the R HKH time of TEG 6S platelet mapping® and the R CKH of TEG 6S citrated®.
timeFrame: After anesthetic induction; 30 min before aortic declamping and 5min after antagonization
measure: Post-operative bleeding over the first 2 hours
timeFrame: during the 2 hours post-surgery
measure: Post-operative bleeding over 12 hours in intensive care
timeFrame: during the 12 hours post-surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Benjamin Bourdois, MD
role: STUDY_DIRECTOR
References:
citation: 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.