NCT05672589

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

Status unknown NA Last updated 18 June 2023

What this trial tests

NA trial testing Relaxed Rotational Thromboelastometry in Liver Cirrhosis in 1,050 participants. Status unknown.

Timeline

2 February 2023

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Institute of Liver and Biliary Sciences, India
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,050
Start date	2 February 2023
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across India

Drugs / interventions tested

• Relaxed Rotational Thromboelastometry
• Standard Coagulation Tests

Conditions studied

• Liver Cirrhosis — all drugs for Liver Cirrhosis →
• Acute on Chronic Liver Failure — all drugs for Acute on Chronic Liver Failure →

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

18 and older, any sex, with Liver Cirrhosis or Acute on Chronic Liver Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Does the Use of Viscoelastic Hemostatic Assays for Periprocedural Hemostasis Management in Liver Disease Improve Clinical Outcomes?
   Maynard S, Marrinan E, Roberts L, Stanworth S. · · 2024 · cited 1× · PMID 38616454 · DOI 10.1016/j.tmrv.2024.150823