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

Institute of Liver and Biliary Sciences, India

Status: Enrolling

Conditions: Acute-On-Chronic Liver Failure

Treatments: Diagnostic Test: ROTEM

Study type: Interventional

Funder types: Other

Identifiers

NCT06831565

ILBS-ACLF-21

Details and patient eligibility

About

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.

Full description

Aim and Objective - To evaluate the efficacy and safety of relaxed threshold (compared to threshold) for blood product transfusion for invasive procedures in cirrhosis and ACLF patients.

Hypothesis - Relaxing the threshold ( as compared to conventional threshold ) for blood product transfusion will decrease the need for blood products without increase the bleeding complications for invasive procedures in cirrhosis and acute on chronic liver failure patients( ACLF)

Sample size with justification:

Assuming the prevalence rate is 50% (TUSHAR THESIS -yet to be published), that is need of transfusion of blood produtcs in standard cutoff and relaxed cutoff , as according to this study the need in relaxed cut off has been reduced,investigator assumed the need in High cut off group is reduced to 40%, with alpha-5%, power-80%, investigator need to enroll 417 in each group with defaulter of 10% , it decided to have cases that is 934 total Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization investigator will assess the need for transfusion , and complications post procedure , post transfusion if any for a duration of 1month.

Intervention: Patient after screening for all exclusion criteria will be randomized to procedure after or before transfusion of blood products and will be assessed the safety of procedure related bleed and need of intervention post procedure if any

Enrollment: 934 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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934 participants in 3 patient groups

Low Cut Off

Active Comparator group

Description:

EXTEM CT\>80sec, CL130\<50% FIBTEM- Mcf\>8

Treatment:

Diagnostic Test: ROTEM

High Cut Off

Experimental group

Description:

EXTEM CT\>100sec, CL130\<40% FIBTEM- Mcf\<6

Treatment:

Diagnostic Test: ROTEM

On demand

No Intervention group

Description:

No pre procedure blood products transfusions will be given. Transfusions will be given after the procedure if any bleeding complications occur