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Haemonetics, the company that manages the TEG device, has given a negative answer as to the continuation of the study. For technical and internal reasons, they will take over the device.
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEG®6S device with its Platelet mapping® cartridge | Device | Platelet function monitoring using the TEG®6S device with its Platelet mapping® cartridge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Major persons operated on for cardiac surgery under extracorporeal circulation
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| Name | Affiliation | Role |
|---|---|---|
| Adrien BOUGLE, MD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Ahmed ABBES, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département d'Anesthésie-Réanimation,Hopital Pitié Salpêtrière | Paris | 75013 | France |
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| 24 hours after inclusion |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |