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To compare diagnostic methods in liver disease.

To compare relaxed rotational thromboelastometry cut-offs with standard cut-offs for guiding blood product use before invasive procedures in cirrhosis and acute on chronic liver failure patients: A Randomized Controlled Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049423
Enrollment
1050
Registered
2023-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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: relaxed rotational thromboelastometry: relaxed rotational thromboelastometry will be done 12 hr,24 hr,48 hr, 72 hr and if patients bleed. Control Intervention1: Standard coagulation tes

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Cirrhosis and/or ACLF patients >18 yrs, scheduled to undergo an high risk invasive procedure with severe coagulopathy requiring correction as per risk category and degree of coagulopathy on conventional coagulation tests.

Exclusion criteria

Exclusion criteria: 1. Ongoing bleeding 2. Bleeding within last 3 days 3. ACLF patients going for LT may be added in exclusion criteria 4. Antiplatelet or anticoagulant therapy (discontinued 5. Hemodialysis in last 3 days

Design outcomes

Primary

MeasureTime frame
To compare the proportion of patients requiring any blood products transfusion (i.e FFP / platelets / cryoprecipitate)Timepoint: At the time of procedure.

Secondary

MeasureTime frame
To compare the amount of cryoprecipitate transfused (units) in patients requiring cryoprecipitate transfusion per patientTimepoint: At the time of procedure.;To compare the amount of FFP transfused (mL) in patients requiring FFP transfusion per patientTimepoint: At the time of procedure.;To compare the amount of platelets transfused (SDAP units) in patients requiring platelet transfusion per patientTimepoint: At the time of procedure.;To compare the cost incurredTimepoint: At the time of procedure.;To compare the occurrence of bleeding, defined as overt bleeding or hemoglobin drop requiring transfusion with a target of 8 g/dL 28 days patient survivalTimepoint: 28 days;To compare the proportion of patients requiring cryoprecipitate transfusionTimepoint: At the time of procedure.;To compare the proportion of patients requiring FFP transfusionTimepoint: At the time of procedure.;To compare the proportion of patients requiring platelets transfusionTimepoint: At the time of procedure.;To compare the proportion of patients requiring tranexamic acid infusionTimepoint: At the time of procedure.;To compare the transfusion-related side effects, defined as any side effect occurring within 6 hours of blood products infusion; and Procedure-related complications other than bleedingTimepoint: 6 hours

Countries

India

Contacts

Public ContactDr Manoj Kumar Sharma

Institute of Liver and Biliary Sciences

manojkumardm@gmail.com09717270640

Outcome results

None listed

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