Use of a diagnostic test technique for deciding the transfusion of blood products in liver disease patients.

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. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079054

Enrollment

934

Registered

2025-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: High Cut Off ROTEM Tests: EXTEM CT m0re than 100sec, CL130 less than 40% FIBTEM- Mcf less than 6 Control Intervention1: Low Cut Off ROTEM Tests: EXTEM CT more than 80sec, CL130 less tha

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cirrhosis and ACLF ( as per definition) 2. Planned to undergo invasive procedures 3. Severe Coagulopathy- INR more than 2.0 or Platelets less than 30k or Fibrinogen less than 100mg per dl

Exclusion criteria

Exclusion criteria: 1. Ongoing bleeding 2. Bleeding in past 48 hours before procedure 3. Antiplatelet or anticoagulant therapy ( stopped less than 7 days before)

Design outcomes

Primary

Measure	Time frame
Compare the effectiveness of High cutoff vs Low cut off ROTEM in guiding blood products use before invasive procedures in cirrhosis and ACLF patients Timepoint: 28 days	—

Secondary

Measure	Time frame
Assess the impact of ROTEM on transfusion requirementsTimepoint: 28 days;Evaluate the incidence of bleeding events post procedure in Low cutoffTimepoint: 28 days;Evaluate the mortality in patients with procedural bleeding.Timepoint: 28 days;Assess the patient requiring procedural based treatment after post procedural bleed.Timepoint: 28 days;To compare the rate of transfusion reactions in relaxed ROTEM vs standard ROTEM in cirrhosis and ACLF.Timepoint: 28 days	—

Measure

Time frame

Assess the impact of ROTEM on transfusion requirementsTimepoint: 28 days;Evaluate the incidence of bleeding events post procedure in Low cutoffTimepoint: 28 days;Evaluate the mortality in patients with procedural bleeding.Timepoint: 28 days;Assess the patient requiring procedural based treatment after post procedural bleed.Timepoint: 28 days;To compare the rate of transfusion reactions in relaxed ROTEM vs standard ROTEM in cirrhosis and ACLF.Timepoint: 28 days

—

Countries

India

Contacts

Public ContactDr Manoj Kumar Sharma

Institute of Liver and Biliary Sciences

manojkumardm@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026