TEG 6s® for Perioperative Monitoring of Platelet Function During Cardiopulmonary Bypass for Cardiac Surgery

Terminated

• Conditions: Cardiopulmonary Bypass

• Registration Number: NCT04746560
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Excessive bleeding is common during cardiopulmonary bypass (CPB) for cardiac surgery. This may result from the systemic activation of the coagulation pathway and the acquired platelet dysfunction during the procedure. This study aims to compare the diagnostic performances of the TEG®6S device and its Platelet mapping® cartridge to those of the "gold standard" tests (light transmittance aggregometry and Multiplate®) for platelet function monitoring in patients undergoing CPB for cardiac surgery.

Detailed Description

Excessive bleeding is common during cardiopulmonary bypass (CPB) for cardiac surgery. This may result from the systemic activation of the coagulation pathway and the acquired platelet dysfunction during the procedure. This study aims to compare the diagnostic performances of the TEG®6S device and its Platelet mapping® cartridge to those of the "gold standard" tests (light transmittance aggregometry and Multiplate®) for platelet function monitoring in patients undergoing CPB for cardiac surgery.

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2021-02-06
• Study First Posted: 2021-02-10
• Study Start: 2021-04-21
• Primary Completion: 2021-05-07
• Study Completion: 2021-05-07
• Status Verified: 2021-09
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Patients scheduled to undergo cardiopulmonary bypass
• Informed consent

Exclusion Criteria

• Age <18 years
• Pregnant women
• Emergency surgery
• Cardiac surgery without CPB
• thrombocytopenia <100000/mmm3

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the diagnostic performance of the TEG®6S device and its Platelet mapping cartridge with that of the reference tests used in the hematology laboratory for the evaluation of platelet function	6 hours after inclusion	Comparison of the results of reference tests used in the hematology laboratory for the evaluation of platelet function such as the results of total blood aggregometry by impedance (Multiplate®: TRAPtest, ASPItest and ADPtest), with the results of the TEG® Platelet mapping® cartridge (MA fibrin, MA-ADP, MA-AA) obtained at the different pre, per and post-extracorporeal circulation sampling times

Secondary Outcome Measures

Name	Time	Method
Compare the diagnostic performance of the TEG®6S device and its Platelet mapping® cartridge with the reference tests used in the hematology laboratory for the prediction of the risk of post-cardiopulmonary bypass bleeding.	24 hours after inclusion	Compare results obtained at different sampling times (pre, per and post-extracorporeal circulation) of the diagnostic performance of the TEG®6S device and its Platelet mapping® cartridge with the reference tests used in the hematology laboratory for the prediction of the risk of post-cardiopulmonary bypass bleeding, using; ・ The amount of bleeding in the drains at the 24th hour after surgery
Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass	24 hours after inclusion	Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass by statistical analysis of: ・ The amount of bleeding in the drains at the 24th hour after surgery

Trial Locations

Locations (1)

Département d'Anesthésie-Réanimation,Hopital Pitié Salpêtrière; 🇫🇷 Paris, France