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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06230640
Study type Observational
Source University Hospital, Montpellier
Contact Benjamin Bourdois, MD
Phone 04.67.33.59.58
Email b-bourdois@chu-montpellier.fr
Status Not yet recruiting
Phase
Start date February 2024
Completion date February 2025

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