Diagnosis and Management of Impaired Thrombin Generation in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Thrombin Generation, as assessed by the Time to Peak
研究概览
简要总结
Coagulopathy, bleeding, and transfusion are common in cardiac surgical patients. Our collaborator has developed a novel point of care device that can be used to assess thrombin generation in real-time in cardiac surgical patients. The investigators will measure thrombin generation using our novel device and compare it to standard methods, while examining the association of thrombin parameters with bleeding and other clinical outcomes.
详细描述
This is a prospective observational cohort study of 200 cardiac surgical patients. Thrombin generation via our novel point of care thrombin generation assay as well as calibrated automated thrombography (CAT) will be measured at three time points: (1) before surgery; (2) post-CPB after heparin reversal with protamine; (3) at the time of chest closure or 60 minutes after heparin reversal with protamine. Clinicians will remain blinded to the measures. Recruitment will continue until the investigators enroll 50 patients with significant impaired thrombin generation capacity (>50% drop from baseline) and 50 patients who receive hemostatic therapies. Patients will be followed for 7 days postoperatively to assess individual products transfused.
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
- •All adult patients (> 18 years of age) undergoing cardiac surgery at Toronto General Hospital will be offered participation.
排除标准
- •Patients who are unable to consent to the study or who refuse participation will be excluded.
结局指标
主要结局
Thrombin Generation, as assessed by the Time to Peak
时间窗: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
The co-primary thrombin generation parameter of interest is the Time to Peak, expressed in seconds. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Thrombin Generation, as assessed by the Peak Height
时间窗: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
The co-primary thrombin generation parameter of interest is the Peak Height, expressed in nM. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Thrombin Generation, as assessed by the Endogenous Thrombin Potential (ETP)
时间窗: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
The primary thrombin generation parameter of interest is the endogenous thrombin potential, or ETP, expressed in nM\*min. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Thrombin Generation, as assessed by the Lag Time
时间窗: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
The co-primary thrombin generation parameter of interest is the Lag Time, expressed in seconds. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
次要结局
- Total amount of Prothrombin Complex Concentrates transfused(From intra-operatively up to 12 hours post-operatively)
- Total Units of Red Blood Cells Transfused(From intra-operatively up to 12 hours post-operatively)
- Total Units of Platelets Transfused(From intra-operatively up to 12 hours post-operatively)
- Total amount of Fibrinogen Concentrate transfused(From intra-operatively up to 12 hours post-operatively)
- Total Units of Frozen Plasma Transfused(From intra-operatively up to 12 hours post-operatively)