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NCT04746560 Clinical Trial

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

Cardiopulmonary Bypass Clinical Trial

— TEG-PM  

Official title:
Evaluation of the Diagnostic Performances of the TEG 6s® Hemostasis Device and Its Platelet Mapping® Cartridge for Perioperative Monitoring of Platelet Function During Cardiopulmonary Bypass for Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04746560
Other study ID # APHP201216
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 21, 2021
Est. completion date May 7, 2021

Study information
Verified date September 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date May 7, 2021
Est. primary completion date May 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• TEG®6S device with its Platelet mapping® cartridge
Platelet function monitoring using the TEG®6S device with its Platelet mapping® cartridge

Locations
Country Name City State
France Département d'Anesthésie-Réanimation,Hopital Pitié Salpêtrière Paris

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Comparison of the results of reference tests used in the hematology laboratory for the evaluation of platelet function such as platelet aggregation in photometry (ADP, arachidonic acid, TRAP),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 6 hours after inclusion
Primary 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 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 6 hours after inclusion
Secondary 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. 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 results of platelet aggregation in photometry (ADP, arachidonic acid, TRAP) 24 hours after inclusion
Secondary 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. 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 results of total blood aggregometry by impedance (Multiplate®: TRAPtest, ASPItest and ADPtest) 24 hours after inclusion
Secondary 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. 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 TEG® Platelet mapping® cartridge results (MA fibrin, MA-ADP, MA-AA) 24 hours after inclusion
Secondary 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. 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 Global Haemostasis® cartridge results (R and K times, angle, amplitudes MA, A30 and A60) obtained at different sampling times 24 hours after inclusion
Secondary 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. 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 Number and type of blood products transfused at the 24th hour after surgery 24 hours after inclusion
Secondary 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. 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		 24 hours after inclusion
Secondary 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 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 results of platelet aggregation in photometry (ADP, arachidonic acid, TRAP) 24 hours after inclusion
Secondary 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 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 results of total blood aggregometry by impedance (Multiplate®: TRAPtest, ASPItest and ADPtest) 24 hours after inclusion
Secondary 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 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: · TEG® Platelet mapping® cartridge results (MA fibrin, MA-ADP, MA-AA) 24 hours after inclusion
Secondary 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 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: · Global Haemostasis® cartridge results (R and K times, angle, amplitudes MA, A30 and A60) ; obtained at different sampling times 24 hours after inclusion
Secondary 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 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: · Number and type of blood products transfused at the 24th hour after surgery 24 hours after inclusion
Secondary 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 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 24 hours after inclusion
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