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Clinical Trials in India / NCT06831565
Recruiting Not applicable

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 · tracked via the Priya Life Science India tracker
Sponsor
Institute of Liver and Biliary Sciences, India
Phase
Not applicable
Started
2025-03-19
Last updated
2026-07-07

Condition(s) studied

Acute-On-Chronic Liver Failure

Investigational drug(s) / intervention(s)

ROTEM

ROTEM: ROTEM Tests

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Liver & Biliary Sciences (ILBS) New Delhi National Capital Territory of Delhi Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06831565 on ClinicalTrials.gov ↗ ← All trials in India