Using different ROTEM cut-offs to guide blood transfusions before procedures in cirrhosis and ACLF

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

This will test whether using relaxed ROTEM cut-offs to decide on blood transfusions reduces the number of transfusions without raising bleeding risk for people with cirrhosis or ACLF and severe coagulopathy who need invasive procedures.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 934 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Institute of Liver and Biliary Sciences, India (other)
• Locations: 1 site (New Delhi, National Capital Territory of Delhi)
• Trial ID: NCT06831565 on ClinicalTrials.gov

What this trial studies

Adults with cirrhosis or acute-on-chronic liver failure (ACLF) and severe coagulopathy who are scheduled for invasive procedures will be randomized to transfusion decisions guided by relaxed ROTEM cut-offs versus conventional thresholds. The trial compares the amount of blood products used and the rate of procedure-related bleeding and complications, with follow-up for one month. Investigators plan to enroll about 934 patients to detect a clinically meaningful reduction in transfusion need with adequate statistical power. All participants undergo baseline screening, standardized procedure management, and monitoring for bleeding and transfusion-related adverse events.

Who should consider this trial

Good fit: Adults with cirrhosis or ACLF who are scheduled for an invasive procedure and have severe coagulopathy (INR > 2.0, platelets < 30,000/µL, or fibrinogen < 100 mg/dL) and who are not actively bleeding meet the ideal candidate profile.

Not a fit: Patients with active or very recent bleeding, recent antiplatelet/anticoagulant use, or only mild coagulation abnormalities are unlikely to benefit from the relaxed ROTEM-guided transfusion thresholds tested here.

Why it matters

Potential benefit: If successful, this approach could reduce unnecessary blood transfusions and their risks while keeping procedure-related bleeding rates low.

How similar studies have performed: Smaller observational studies and some interventional work have suggested ROTEM-guided transfusion can reduce blood product use compared with conventional tests, but randomized data specifically in cirrhosis/ACLF remain limited.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Ongoing bleeding
2. Bleeding in past 48 hours before procedure
3. Antiplatelet or anticoagulant therapy ( stopped \< 7 days before)

Where this trial is running

New Delhi, National Capital Territory of Delhi

• Institute of Liver & Biliary Sciences (ILBS) — New Delhi, National Capital Territory of Delhi, India (RECRUITING)

Study contacts

• Study coordinator: Dr Sanda Kavitha, MD

Conditions: Acute-On-Chronic Liver Failure