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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
Conditions: Liver Cirrhosis, Acute on Chronic Liver Failure
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 1050
Sponsor: Institute of Liver and Biliary Sciences, India
Location: India
Summary
HypothesisRelaxed 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) patientsAIM:- 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) patientsObjective -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.
Eligibility Criteria
Inclusion Criteria:- All Cirrhosis and/or ACLF patients >18 yrs, scheduled to undergo an high risk invasive procedure with severe coagulopathy requiring correction as per risk category and degree of coagulopathy on conventional coagulation tests.Exclusion Criteria:Ongoing bleedingBleeding within last 3 daysACLF patients going for LT may be added in exclusion criteriaAntiplatelet or anticoagulant therapy (discontinued <7 d before)Hemodialysis in last 3 days
Source: ClinicalTrials.gov (NCT05672589). StuddyBuddy aggregates publicly available trial information.