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

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

Inclusion criteria

• Cirrhosis and ACLF ( as per definition)
• Planned to undergo invasive procedures
• Severe Coagulopathy- INR>2.0 or Platelets <30k or Fibrinogen<100mg/dl .

Exclusion criteria

• Ongoing bleeding
• Bleeding in past 48 hours before procedure
• Antiplatelet or anticoagulant therapy ( stopped < 7 days before)