Actively Recruiting
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
Led by Institute of Liver and Biliary Sciences, India · Updated on 2025-07-01
934
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with cirrhosis or acute-on-chronic liver failure (ACLF)
- Planned to undergo an invasive procedure
- Severe coagulopathy defined as INR greater than 2.0, platelet count less than 30,000, or fibrinogen less than 100 mg/dl
You will not qualify if you...
- Currently experiencing active bleeding
- Had bleeding within 48 hours before the procedure
- Taking antiplatelet or anticoagulant therapy stopped less than 7 days before the procedure
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070
Actively Recruiting
Research Team
D
Dr Sanda Kavitha, MD
CONTACT
D
Dr Manoj Kumar Sharma, DM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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