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
- 不适用
- 状态
- 招募中
- 入组人数
- 790
- 试验地点
- 2
- 主要终点
- Proportion of patients with reduction in the amount of total components transfused in high cut off ROTEM compared to low cut off ROTEM in cirrhosis and ACLF patients.
研究概览
简要总结
Coagulation system in cirrhotics patients is a fragile state , which is rebalanced hemostasis. Standard tests (INR/aPTT) stop measuring at first stage of coagulation ,when the clot first form. VETs measure the whole process such as ROTEM, TEG and comparing these two tests to assess for transfusion of blood products for invasive procedures. . ROTEM provides information both on anti coagulant and procoagulant status where as conventional tests provide only anti coagulant status Invasive procedures can be low risk or high risk or Non surgical vs surgical, Procedure related bleed occurs in 7% of patients with cirrhosis and associated with higher 28 day mortality. MELD, CTP ,AKI , SEPSIS increase the risk of procedure related bleed. Hence for invasive procedures investigator is using relaxing threshold for blood product transfusion in cirrhosis, ACLF patients. As use of ROTEM when compared to conventional tests reduces the need for blood transfusion. Investigator want to proceed with further relaxation of cutoff values of Coagulation parameters and use High cutoff vs low cut off for blood transfusion need.
详细描述
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,investigator assumed the need in High cut off group is reduced to 40%, with alpha-5%, power-80%, investigator 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 investigator 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
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis and ACLF ( as per definition)
- •Planned to undergo invasive procedures
- •Severe Coagulopathy- INR>2.0 or Platelets <30k or Fibrinogen<100mg/dl .
排除标准
- •Ongoing bleeding
- •Bleeding in past 48 hours before procedure
- •Antiplatelet or anticoagulant therapy ( stopped < 7 days before)
研究组 & 干预措施
Low Cut Off
EXTEM CT>80sec, CL130<50% FIBTEM- Mcf>8
干预措施: ROTEM (Diagnostic Test)
High Cut Off
EXTEM CT>100sec, CL130<40% FIBTEM- Mcf<6
干预措施: ROTEM (Diagnostic Test)
On demand
No pre procedure blood products transfusions will be given. Transfusions will be given after the procedure if any bleeding complications occur
结局指标
主要结局
Proportion of patients with reduction in the amount of total components transfused in high cut off ROTEM compared to low cut off ROTEM in cirrhosis and ACLF patients.
时间窗: Day 28
High Cutoff defined as need of low blood transfusion products (CT-\>100sec,MCF\<25,CLI30\<40%,MCF -FIB\<6mm) and Low Cut off defined as (CT -\>80sec, MCF\<35, CLI30\<50%,MCF-FIB\<6mm)
次要结局
- Evaluate the incidence of bleeding events post procedure in Low cutoff.(Day 28)
- Mortality related with procedural bleeding in both groups.(Day 28)
- Assess the impact of ROTEM on transfusion requirements.(Day 28)
- Proportion of the patient requiring procedural based treatment that is number of blood transfusions, angioembolization after post procedural bleed.(Day 28)
- To compare the rate of transfusion reactions in relaxed ROTEM vs standard ROTEM in cirrhosis and ACLF.(Day 28)