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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

NCT05672589 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2023-06-18

No results posted yet for this study

Summary

Hypothesis

Relaxed ROTEM cutoff guided blood product transfusion will result in less blood products use without increasing bleeding complications for invasive procedures in cirrhosis or acute on chronic liver failure (ACLF) patients

AIM:- To evaluate the efficacy and safety of Relaxed threshold (as compared to conventional thresholds) for blood product transfusion for invasive procedures in cirrhosis or acute on chronic liver failure (ACLF) patients

Objective -

Primary objective:

To compare the reduction in amount of total component transfused (ml/kg) in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.

Secondary objectives:

To compare the amount of FFP (ml/kg) transfused in Relaxed Rotational Thromboelastometry cut off based versus Standard Rotational Thromboelastometry cut off based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.

To compare the amount of Platelet (ml/kg) transfused in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.

To compare the amount of cryoprecipitate (ml/kg) transfused in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.

To compare the bleeding rate in Relaxed Rotational Thromboelastometry cut off based versus Conventional Rotational Thromboelastometry cut off based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.

To compare the rate of transfusion reactions in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.

To compare the cost incurred in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.

Conditions

Interventions

DIAGNOSTIC_TEST

Relaxed Rotational Thromboelastometry

Relaxed rotational thromboelastometry will be done 12 hr,24 hr,48 hr, 72 hr and if patients. bleed.

DIAGNOSTIC_TEST

Standard Coagulation Tests

Standard coagulation tests will be done baseline,12 hr,24 hr,48 hr, 72 hr and if patients bleed.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05672589 on ClinicalTrials.gov