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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cirrhosis and ACLF ( as per definition)

Planned to undergo invasive procedures

Severe Coagulopathy- INR>2.0 or Platelets <30k or Fibrinogen<100mg/dl .

Disqualifiers

Ongoing bleeding

Bleeding in past 48 hours before procedure

Antiplatelet or anticoagulant therapy ( stopped < 7 days before)

Trial design

Design model

Parallel

Treatments tested in this trial

  • ROTEM

    Diagnostic test

    ROTEM Tests

Treatment groups

790 Participants
are divided into 3 treatment groups
Group A: Low Cut OffActive comparator 1 intervention
Group B: High Cut OffExperimental treatment 1 intervention
Group C: On demandNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients with reduction in the amount of total components transfused in high cut off ROTEM compared to low cut off ROTEM in cirrhosis and ACLF patients.

High Cutoff defined as need of low blood transfusion products (CT-\>100sec,MCF\<25,CLI30\<40%,MCF -FIB\<6mm) and Low Cut off defined as (CT -\>80sec, MCF\<35, CLI30\<50%,MCF-FIB\<6mm)

Time frame
Day 28

Secondary outcomes

1

Assess the impact of ROTEM on transfusion requirements.

Impact of standard ROTEM on transfusion requirements that is proportion Of FFP, PLATELETS,CRYO, PCC, FIBRINOGEN before procedure in cirrhosis and ACLF patients.

Time frame
Day 28
2

Evaluate the incidence of bleeding events post procedure in Low cutoff.

Time frame
Day 28
3

Mortality related with procedural bleeding in both groups.

Time frame
Day 28
4

Proportion of the patient requiring procedural based treatment that is number of blood transfusions, angioembolization after post procedural bleed.

Time frame
Day 28

Other outcomes

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