Cardiac Surgery, Cardiopulmonary Bypass, Coagulopathy
Conditions
Keywords
Coagulopathy, cardiac surgery, cardiopulmonary bypass
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTIn vitro medical diagnostic device TEG6s® Platelet Mapping
Preoperative period: * Pre-operative blood sampling, according to the usual practices of the unit before surgery * Collection of the patient's usual demographic characteristics per operative period : * After anesthetic induction:a TEG6S platelet mapping® sampled from the arterial catheter routinely placed after anesthetic induction * During the CPB, 30 min before aortic declamping: performing TEG 6S platelet mapping® (heparinized tube) * 5 min after heparin antagonization by protamine, after the weaning of the bypass, and before any transfusion: performing a TEG 6S citrate® (citrated tube) Post-operative period (resuscitation): • postoperative bleeding at 2 hours and during the first 12 hours.
Sponsors
University Hospital, Montpellier
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or older * Cardiac surgery under cardiopulmonary bypass with high risk of bleeding defined among: * CPB with circulatory arrest * cardiac transplantation * Redo surgery * infective endocarditis * predicted duration of CBP ≥ 120 min * High transfusion risk defined by a Trust predictive score ≥ 3 (Transfusion Risk Understanding Scoring Tool)
Exclusion criteria
* Patient with heparin allergy or heparin-induced thrombocytopenia * Use of direct oral anticoagulant (DAA) with anti-factor X activity (Apixaban, Rivaroxaban) \< 72h, even if antagonized * Patient on partially or fully antagonized VKAs * Opposition to participation after a period of reflection * Adult protected by law (guardianship, curatorship) * Person deprived of liberty * Person participating in another study with an exclusion period still in progress * Patient not affiliated to a social security scheme or not benefiting from such a scheme * Pregnant or breast-feeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass. | After anesthetic induction; 30 min before aortic declamping and 5min after antagonization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in maximum amplitude in the presence of fibrinogen activator (MA ActF) of TEG 6S platelet mapping® during CPB. | After anesthetic induction; 30 min before aortic declamping | 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. |
| Maximum amplitude change in the presence of arachidonic acid (MA AA) in TEG 6S platelet mapping® during CPB. | After anesthetic induction; 30 min before aortic declamping | 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. |
| Maximum amplitude change in the presence of P2Y12 receptor activating ADP (MA ADP) of TEG 6S platelet mapping® during CPB. | After anesthetic induction; 30 min before aortic declamping | 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. |
| Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB. | After anesthetic induction; 30 min before aortic declamping | 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. |
| Post-operative bleeding over the first 2 hours | during the 2 hours post-surgery | Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL) |
| Post-operative bleeding over 12 hours in intensive care | during the 12 hours post-surgery | Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL) |
| Correlation between the R HKH time of TEG 6S platelet mapping® and the R CKH of TEG 6S citrated®. | After anesthetic induction; 30 min before aortic declamping and 5min after antagonization | 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. |
Countries
France
Outcome results
None listed