Comparison of Blood Products Required Using Two Different ROTEM Cut-offs Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure (ACLF) Patients With Severe Coagulopathy: A Randomized Controlled Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 934
- 试验地点
- 1
- 主要终点
- Compare the effectiveness of High cutoff vs Low cut off ROTEM in guiding blood products use before invasive procedures in cirrhosis and ACLF patients
研究概览
简要总结
Aim and Objective - To evaluate the efficacy and safety of relaxed threshold (compared to threshold) for blood product transfusion for invasive procedures in cirrhosis and ACLF patients.
Hypothesis - Relaxing the threshold ( as compared to conventional threshold ) for blood product transfusion will decrease the need for blood products without increase the bleeding complications for invasive procedures in cirrhosis and acute on chronic liver failure patients( ACLF)
Sample size with justification:
Assuming the prevalence rate is 50% (TUSHAR THESIS -yet to be published), that is need of transfusion of blood produtcs in standard cutoff and relaxed cutoff , as according to this study the need in relaxed cut off has been reduced,we assumed the need in High cut off group is reduced to 40%, with alpha-5%, power-80%, we need to enroll 417 in each group with defaulter of 10% , it decided to have cases that is 934 total Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization we will assess the need for transfusion , and complications post procedure , post transfusion if any for a duration of 1month.
Intervention: Patient after screening for all exclusion criteria will be randomized to procedure after or before transfusion of blood products and will be assessed the safety of procedure related bleed and need of intervention post procedure if any
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Cirrhosis and ACLF ( as per definition)
- •Planned to undergo invasive procedures
- •Severe Coagulopathy- INR more than 2.0 or Platelets less than 30k or Fibrinogen less than 100mg per dl.
排除标准
- •Ongoing bleeding
- •Bleeding in past 48 hours before procedure
- •Antiplatelet or anticoagulant therapy ( stopped less than 7 days before).
结局指标
主要结局
Compare the effectiveness of High cutoff vs Low cut off ROTEM in guiding blood products use before invasive procedures in cirrhosis and ACLF patients
时间窗: 28 days
次要结局
- Assess the impact of ROTEM on transfusion requirements(28 days)
- Evaluate the incidence of bleeding events post procedure in Low cutoff(28 days)
- Evaluate the mortality in patients with procedural bleeding.(28 days)
- Assess the patient requiring procedural based treatment after post procedural bleed.(28 days)
- To compare the rate of transfusion reactions in relaxed ROTEM vs standard ROTEM in cirrhosis and ACLF.(28 days)
研究者
Dr Sanda Kavitha
Institute of Liver and Biliary Sciences