Actively Recruiting
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
Led by Institute of Liver and Biliary Sciences, India · Updated on 2025-07-01
934
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with cirrhosis and acute-on-chronic liver failure (ACLF) who have severe coagulopathy, a fragile balance in their blood clotting system. This study evaluates the use of two different ROTEM test cutoff values to guide blood product transfusions before invasive procedures. The goal is to see if relaxing the threshold for transfusions reduces the need for blood products without increasing bleeding complications, as bleeding after procedures is a serious risk in these patients. Participants will be randomly assigned to one of three groups: a low cutoff ROTEM group, a high cutoff ROTEM group, or an on-demand group where transfusions are only given after the procedure if bleeding occurs. The study compares how much blood product is used and monitors safety outcomes related to bleeding and transfusion reactions. This randomized controlled trial will enroll about 934 patients and follow them for 28 days after their procedure. During the study, patients will have vital and baseline screenings before randomization. Researchers will assess transfusion needs based on ROTEM results and monitor for bleeding events, complications, and mortality related to procedural bleeding over one month. The main outcome is the proportion of patients who require fewer blood components transfused using the high cutoff compared to the low cutoff ROTEM values. Safety and transfusion reaction rates are also tracked throughout the study.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of cirrhosis or acute-on-chronic liver failure (ACLF) as per study definition
- Planned to undergo an invasive procedure
- Severe coagulopathy defined as INR greater than 2.0 or platelet count less than 30,000 or fibrinogen less than 100 mg/dl
You will not qualify if you...
- Ongoing bleeding at the time of screening
- Bleeding within 48 hours before the procedure
- Use of antiplatelet or anticoagulant therapy stopped less than 7 days before the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo ROTEM testing to determine transfusion thresholds before invasive procedures.
1 visit (in-person)
Duration - Procedure day and immediate post procedure period
Participants receive blood product transfusions based on randomized ROTEM cut-offs before invasive procedures, or receive transfusions post procedure if bleeding occurs.
1 visit (in-person) on procedure day
Duration - Up to 28 days
Participants are monitored for transfusion needs, bleeding complications, and related outcomes for up to 28 days after the procedure.
Periodic visits during 28 days post procedure
Trial Site Locations
Total: 1 location
1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070
Actively Recruiting
Research Team
D
Dr Sanda Kavitha, MD
D
Dr Manoj Kumar Sharma, DM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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