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

Cardiac Surgery Clinical Trial

— PREDIPOC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06230640
• Other study ID #: RECHMPL23_0167
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: Benjamin Bourdois, MD
• Phone: 04.67.33.59.58
• Email: b-bourdois[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 59
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Cardiac Surgery
• Cardiopulmonary Bypass
• Coagulopathy
• Hemostatic Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & 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):7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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