To Compare Relaxed Rotational Thromboelastometry Cut-offs With Standard Cut-offs for Guiding Blood Product Use Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,050
- 试验地点
- 2
- 主要终点
- To compare the proportion of patients requiring any blood products transfusion (i.e FFP / platelets / cryoprecipitate)
研究概览
简要总结
Hypothesis
Relaxed ROTEM cutoff guided blood product transfusion will result in less blood products use without increasing bleeding complications for invasive procedures in cirrhosis or acute on chronic liver failure (ACLF) patients
AIM:- To evaluate the efficacy and safety of Relaxed threshold (as compared to conventional thresholds) for blood product transfusion for invasive procedures in cirrhosis or acute on chronic liver failure (ACLF) patients
Objective -
Primary objective:
To compare the reduction in amount of total component transfused (ml/kg) in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.
Secondary objectives:
To compare the amount of FFP (ml/kg) transfused in Relaxed Rotational Thromboelastometry cut off based versus Standard Rotational Thromboelastometry cut off based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.
To compare the amount of Platelet (ml/kg) transfused in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.
To compare the amount of cryoprecipitate (ml/kg) transfused in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.
To compare the bleeding rate in Relaxed Rotational Thromboelastometry cut off based versus Conventional Rotational Thromboelastometry cut off based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.
To compare the rate of transfusion reactions in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.
To compare the cost incurred in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.
详细描述
Methodology
Investigator will be following guidelines given by Society of Interventional Radiology for any intervention for coagulopathy correction.
Different procedures which are routinely carry out at our institute will be divided into high risk vs low risk as per Society of Interventional Radiology
Low risk: Peripherally inserted central catheter placement, Paracentesis, Thoracocentesis, Central venous cannulation, Lumbar puncture, Dialysis catheter placement
Low risk: Solid organ biopsies, Transjugular intrahepatic portosystemic shunts, Biliary interventions (cholecystostomy tube placement)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 Cirrhosis and/or ACLF patients >18 yrs, scheduled to undergo an high risk invasive procedure with severe coagulopathy requiring correction as per risk category and degree of coagulopathy on conventional coagulation tests.
排除标准
- •Ongoing bleeding
- •Bleeding within last 3 days
- •ACLF patients going for LT may be added in exclusion criteria
- •Antiplatelet or anticoagulant therapy (discontinued <7 d before)
- •Hemodialysis in last 3 days
结局指标
主要结局
To compare the proportion of patients requiring any blood products transfusion (i.e FFP / platelets / cryoprecipitate)
时间窗: 0 hours
次要结局
- To compare the proportion of patients requiring FFP transfusion(0 hours)
- To compare the cost incurred(0 hours)
- To compare the proportion of patients requiring platelets transfusion(0 hours)
- To compare the proportion of patients requiring cryoprecipitate transfusion(0 hours)
- To compare the transfusion-related side effects, defined as any side effect occurring within 6 hours of blood products infusion; and Procedure-related complications other than bleeding(6 hours)
- To compare the amount of FFP transfused (mL) in patients requiring FFP transfusion per patient(0 hours)
- To compare the proportion of patients requiring tranexamic acid infusion(0 hours)
- To compare the amount of platelets transfused (SDAP units) in patients requiring platelet transfusion per patient(0 hours)
- To compare the amount of cryoprecipitate transfused (units) in patients requiring cryoprecipitate transfusion per patient(0 hours)
- To compare the occurrence of bleeding, defined as overt bleeding or hemoglobin drop requiring transfusion with a target of 8 g/dL 28 days patient survival(28 days)