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

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

Treatments tested in this trial

  • ROTEM

Treatment groups

934 Participants
are divided into 3 treatment groups