Clinical Validation of the Use of Global Coagulation Tests Like Thromboelastography and Sonoclot in Liver Disease - A Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Validation of TEG and Sonoclot
研究概览
简要总结
Background: Patients with cirrhosis and acute-on-chronic liver failure (ACLF) may have bleeding complications which can lead to increased mortality. Standard coagulation tests (SCTs) like prothrombin time, platelet count and activated partial thromboplastin do not accurately depict in vivo coagulation profile. Point-of-care viscoelastic coagulation testing devices like thrombo-elastography (TEG) and Sonoclot may be better for guiding patient management.
Methods: This prospective observational study compared and validated the point of care (POC) tests and SCTs in 70, 72 and 25 persons with ACLF, decompensated cirrhosis and healthy controls respectively.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with Acute on Chronic Liver Failure
- •All patients with cirrhosis of Liver
排除标准
- •Recent blood or blood component transfusion in last 2 weeks
- •HIV infection
- •Antiplatelet, anticoagulant or antifibrinolytic therapy
- •Patients on Dialysis
- •Pregnant females
- •Active malignancy in last 5 years
- •Chronic heart failure
- •Chronic pulmonary disease
- •End stage renal disease
结局指标
主要结局
Validation of TEG and Sonoclot
时间窗: Day 3
To clinically validate the comparibility of results obtained from the TEG and Sonoclot instruments
次要结局
- Correlation of Point of care tests with mortality(28 days)
- Correlation of Point of care test with standard coagulation tests(Day 3)
- Correlation of Point of care tests with bleeding event(Day 28)
研究者
Madhumita Premkumar
Assistant Professor
Post Graduate Institute of Medical Education and Research, Chandigarh