Evaluation of TEG 6S Platelet Mapping® During Cardiopulmonary Bypass for Cardiac Surgery to Detect Postoperative Biological Coagulopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass.
时间窗: 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.
次要结局
- Post-operative bleeding over the first 2 hours(during the 2 hours post-surgery)
- 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)
- 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)
- 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)
- Post-operative bleeding over 12 hours in intensive care(during the 12 hours post-surgery)
- Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB.(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.(After anesthetic induction; 30 min before aortic declamping)