Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cardiac surgery with cardiopulmonary bypass | Any subject undergoing cardiac surgery with cardiopulmonary bypass and at high risk of bleeding and transfusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In vitro medical diagnostic device TEG6s® Platelet Mapping | Diagnostic Test | Preoperative period:
per operative period :
Post-operative period (resuscitation): • postoperative bleeding at 2 hours and during the first 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass. | The measurement of the R time (coagulation time in minutes) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory and using the TEG 6S platelet mapping® and global hemostasis® cartridge. | After anesthetic induction; 30 min before aortic declamping and 5min after antagonization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB. | The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge. | After anesthetic induction; 30 min before aortic declamping |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Any subject undergoing cardiac surgery with cardiopulmonary bypass circulation and at high risk of bleeding and transfusion.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Bourdois, MD | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34643817 | Result | Yamamoto Y, Sato Y, Takahashi M, Yamamoto H, Echizen M, Uchida T. TEG6s Platelet Mapping assay for the estimation of plasma fibrinogen concentration during cardiovascular surgery: a single-center prospective observational study. J Anesth. 2022 Feb;36(1):79-88. doi: 10.1007/s00540-021-03009-4. Epub 2021 Oct 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Change in maximum amplitude in the presence of fibrinogen activator (MA ActF) of TEG 6S platelet mapping® during CPB. | The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge. | After anesthetic induction; 30 min before aortic declamping |
| Maximum amplitude change in the presence of arachidonic acid (MA AA) in TEG 6S platelet mapping® during CPB. | The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge. | After anesthetic induction; 30 min before aortic declamping |
| Maximum amplitude change in the presence of P2Y12 receptor activating ADP (MA ADP) of TEG 6S platelet mapping® during CPB. | The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge. | After anesthetic induction; 30 min before aortic declamping |
| Correlation between the R HKH time of TEG 6S platelet mapping® and the R CKH of TEG 6S citrated®. | The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge. | After anesthetic induction; 30 min before aortic declamping and 5min after antagonization |
| Post-operative bleeding over the first 2 hours | Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL) | during the 2 hours post-surgery |
| Post-operative bleeding over 12 hours in intensive care | Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL) | during the 12 hours post-surgery |
| D006425 |
| Hemic and Lymphatic Diseases |