NCT06230640

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2024-01-30
• Last updated: 2025-03-12

Locations

1 site across 1 country: France