Cardiopulmonary Bypass
Conditions
Keywords
Cardiopulmonary bypass, Cardiac Surgery, Platelet function
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.
Interventions
DEVICETEG®6S device with its Platelet mapping® cartridge
Platelet function monitoring using the TEG®6S device with its Platelet mapping® cartridge
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 results of platelet aggregation in photometry (ADP, arachidonic acid, TRAP) |
| 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 results of platelet aggregation in photometry (ADP, arachidonic acid, TRAP) |
Countries
France
Outcome results
None listed