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

NCT06831565 | Recruiting

• 1 other identifier: ILBS-ACLF-21
• Study Type: interventional
• Target: 934
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with reduction in the amount of total components transfused in high cut off ROTEM compared to low cut off ROTEM in cirrhosis and ACLF patients.

  High Cutoff defined as need of low blood transfusion products (CT-\>100sec,MCF\<25,CLI30\<40%,MCF -FIB\<6mm) and Low Cut off defined as (CT -\>80sec, MCF\<35, CLI30\<50%,MCF-FIB\<6mm)

  Day 28

Secondary Outcomes (5)

• Assess the impact of ROTEM on transfusion requirements.

  Day 28

• Evaluate the incidence of bleeding events post procedure in Low cutoff.

  Day 28

• Mortality related with procedural bleeding in both groups.

  Day 28

• Proportion of the patient requiring procedural based treatment that is number of blood transfusions, angioembolization after post procedural bleed.

  Day 28

• To compare the rate of transfusion reactions in relaxed ROTEM vs standard ROTEM in cirrhosis and ACLF.

  Day 28

Study Arms (3)

Low Cut Off

ACTIVE COMPARATOR

EXTEM CT\>80sec, CL130\<50% FIBTEM- Mcf\>8

Diagnostic Test: ROTEM

High Cut Off

EXPERIMENTAL

EXTEM CT\>100sec, CL130\<40% FIBTEM- Mcf\<6

Diagnostic Test: ROTEM

On demand

NO INTERVENTION

No pre procedure blood products transfusions will be given. Transfusions will be given after the procedure if any bleeding complications occur

Interventions

ROTEM DIAGNOSTIC_TEST

ROTEM Tests

High Cut Off; Low Cut Off

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Dr Sanda Kavitha, MD

CONTACT

01146300000; sandakavitha1001@gmail.com

Dr Manoj Kumar Sharma, DM

CONTACT

01146300000; manojkumardm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 18, 2025
• Study Start: March 19, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-01

Locations

IN (1)