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

Recruiting now · Not applicable

Conditions studied: Acute-On-Chronic Liver Failure

In brief

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.

Key facts

Study ID

NCT06831565

Run by

Institute of Liver and Biliary Sciences, India

People needed

790

Starts

2025-03-19

Expected to finish

2026-08-31

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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