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 | Unknown

• 1 other identifier: ILBS-Cirrhosis-51
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief 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

Liver Cirrhosis; Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• To compare the proportion of patients requiring any blood products transfusion (i.e FFP / platelets / cryoprecipitate)

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Secondary Outcomes (10)

• To compare the proportion of patients requiring FFP transfusion

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• To compare the proportion of patients requiring platelets transfusion

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• To compare the proportion of patients requiring cryoprecipitate transfusion

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• To compare the proportion of patients requiring tranexamic acid infusion

  0 hours

• To compare the amount of FFP transfused (mL) in patients requiring FFP transfusion per patient

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Study Arms (2)

Relaxed rotational thromboelastometry

EXPERIMENTAL

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

Diagnostic Test: Relaxed Rotational Thromboelastometry

Standard coagulation tests

ACTIVE COMPARATOR

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

Diagnostic Test: Standard Coagulation Tests

Interventions

Relaxed Rotational Thromboelastometry DIAGNOSTIC_TEST

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

Relaxed rotational thromboelastometry

Standard Coagulation Tests DIAGNOSTIC_TEST

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

Standard coagulation tests

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

• Ongoing bleeding
• Bleeding within last 3 days
• Antiplatelet or anticoagulant therapy (discontinued \<7 d before)
• Hemodialysis in last 3 days

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 11070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency

Central Study Contacts

Dr Tushar Madke, MD

CONTACT

01146300000; drtusharmadke@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: February 2, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 18, 2023

Record last verified: 2022-11

Locations

IN (1)