Diagnosis and Management of Impaired Thrombin Generation in Liver Transplant Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Thrombin Generation - Time to Peak (Seconds)
研究概览
简要总结
This is a prospective observational study of 100 patients undergoing liver transplantation at a single centre. Thrombin generation and kinetics will be assessed using a novel point-of-care device, and compared to conventional measures of hemostasis as well as viscoelastic tests to pinpoint specific coagulation deficits and identify potential therapeutic targets. The clinical course of patients will be followed for major bleeding and transfusion outcomes.
详细描述
Liver transplantation is the only curative option for end stage liver disease, but is associated with high morbidity and mortality. End stage liver disease is known to be accompanied by dysregulated coagulation, which is further exacerbated in the immediate perioperative period by transplantation, leading to both coagulopathic bleeding and thrombosis. Altered thrombin generation is thought to play a key role in the predisposition of these patients for both severe coagulopathic hemorrhage and life-threatening thromboembolic complications. Despite this, thrombin generation during the immediate transplant period in patients with end-stage liver disease is poorly characterized, in part because it is not well reflected by conventional measures of coagulation. This study aims to characterize changes in thrombin generation capacity pre, intra- and post-transplant utilizing a novel point-of-care thrombin generation assay. Other specific aims of the study are to identify risk factors for patients with impaired thrombin generation and will assess the association of impaired thrombin generation with overall clinical bleeding risk. The overarching goal of this work is to develop a point-of-care-testing guided algorithm addressing dysregulated thrombin formation that improves coagulation management without increasing the risk of thromboembolic complications. Ultimately, this line of research will improve the outcomes of liver transplantation.
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) proceeding to imminent (within 24 hours) liver transplantation surgery at Toronto General Hospital will be offered participation.
- •Patients should have end stage liver disease necessitating transplantation. All etiologies of end stage liver disease will be accepted.
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 - Time to Peak (Seconds)
时间窗: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
The change in thrombin generation will be measured in patients undergoing liver transplantation by the Time to Peak (Seconds)
Thrombin Generation - Lag Time (Seconds)
时间窗: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
The change in thrombin generation will be measured in patients undergoing liver transplantation as assessed by the Lag Time (Seconds)
Thrombin Generation - Endogenous Thrombin Potential (nM*min)
时间窗: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
The change in thrombin generation will be measured in patients undergoing liver transplantation, as assessed through the Endogenous Thrombin Potential (nM\*min)
Thrombin Generation - Peak Height (nM)
时间窗: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
The change in thrombin generation will be measured in patients undergoing liver transplantation by the Peak Height (nM)
次要结局
- Conventional Hemostatic Tests - Fibrinogen Level(The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively)
- Viscoelastic Testing(The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively)
- Conventional Hemostatic Tests - INR(The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively)
- Conventional Hemostatic Tests - aPTT(The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively)
- Conventional Hemostatic Tests - Platelet Count(The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively)