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Recruiting NCT06831565

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

Conditions: Acute-On-Chronic Liver Failure

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 790
Sponsor: Institute of Liver and Biliary Sciences, India

Location: Institute of Liver & Biliary Sciences (ILBS) New Delhi National Capital Territory of Delhi

Summary

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

Inclusion Criteria: 1. Cirrhosis and ACLF ( as per definition) 2. Planned to undergo invasive procedures 3. Severe Coagulopathy- INR\>2.0 or Platelets \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06831565). StuddyBuddy aggregates publicly available trial information.