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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Dr Sanda Kavitha, MD
• Email: sandakavitha1001@gmail.com
• Phone: 01146300000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Factors that affect how well mesenchymal stromal cell (MSC) therapy works for hepatitis B–related acute-on-chronic liver failure.

  This project will look back at people with hepatitis B–related ACLF who received MSC infusions to see which factors affect whether the treatment helps.

  Recruiting Sun Yat-sen University · Guangzhou, Guangdong · NCT07198854

• AS1501 in ACLF: a two-stage dose study in adults with acute-on-chronic liver failure

  This Phase II study tests AS1501 given by injection in adults with early ACLF to see if it’s safe and tolerable and to guide dosing.

  Recruiting Phase 2 Shenzhen Third People's Hospital · Shenzhen, Guangdong · NCT06916585

• TAK-242 and G-CSF in ACLF: a new treatment approach for adults with acute-on-chronic liver failure

  This trial tests whether adding TAK-242, with or without G-CSF, to standard ACLF care helps patients with severe alcoholic hepatitis and ACLF.

  Recruiting Phase 2 Yaqrit Ltd · London, Greater London · NCT06890039

• Ceftazidime-avibactam vs high-dose meropenem for ACLF patients with hospital-acquired infections

  This trial tests whether ceftazidime-avibactam can better treat infections in ACLF patients than high-dose meropenem given in extended infusions, aiming to spare carbapenems if possible.

  Recruiting Institute of Liver and Biliary Sciences, India · New Delhi, National Capital Territory of Delhi · NCT06818565

• Evaluating a new treatment for liver failure and sepsis

  This study is testing a new treatment for people with liver failure and sepsis to see if it can help them survive and improve their organ function.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT06562803

• Using CytoSorb device for patients with acute on chronic liver failure

  This study tests if using the CytoSorb device can help lower bilirubin and ammonia levels and improve muscle strength in patients with severe liver failure.

  Recruiting University Hospital, Antwerp · Edegem, Antwerp · NCT06079021

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.