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: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Cirrhosis and ACLF ( as per definition)

• Planned to undergo invasive procedures

• Severe Coagulopathy- INR\>2.0 or Platelets \<30k or Fibrinogen\<100mg/dl .

Locations
Other Locations
India
Institute of Liver & Biliary Sciences (ILBS)
RECRUITING
New Delhi
Contact Information
Primary
Dr Sanda Kavitha, MD
sandakavitha1001@gmail.com
01146300000
Backup
Dr Manoj Kumar Sharma, DM
manojkumardm@gmail.com
01146300000
Time Frame
Start Date: 2025-03-19
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 934
Treatments
Active_comparator: Low Cut Off
EXTEM CT\>80sec, CL130\<50% FIBTEM- Mcf\>8
Experimental: High Cut Off
EXTEM CT\>100sec, CL130\<40% FIBTEM- Mcf\<6
No_intervention: On demand
No pre procedure blood products transfusions will be given. Transfusions will be given after the procedure if any bleeding complications occur
Related Therapeutic Areas
Sponsors
Leads: Institute of Liver and Biliary Sciences, India

This content was sourced from clinicaltrials.gov

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