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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
ROTEM
Diagnostic testROTEM Tests
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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.
Evaluate the incidence of bleeding events post procedure in Low cutoff.
Mortality related with procedural bleeding in both groups.
Proportion of the patient requiring procedural based treatment that is number of blood transfusions, angioembolization after post procedural bleed.
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