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
NCT ID: NCT06831565
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
934 participants
INTERVENTIONAL
2025-03-19
2026-02-28
Brief Summary
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Detailed Description
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Hypothesis - Relaxing the threshold ( as compared to conventional threshold ) for blood product transfusion will decrease the need for blood products without increase the bleeding complications for invasive procedures in cirrhosis and acute on chronic liver failure patients( ACLF)
Sample size with justification:
Assuming the prevalence rate is 50% (TUSHAR THESIS -yet to be published), that is need of transfusion of blood produtcs in standard cutoff and relaxed cutoff , as according to this study the need in relaxed cut off has been reduced,investigator assumed the need in High cut off group is reduced to 40%, with alpha-5%, power-80%, investigator need to enroll 417 in each group with defaulter of 10% , it decided to have cases that is 934 total Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization investigator will assess the need for transfusion , and complications post procedure , post transfusion if any for a duration of 1month.
Intervention: Patient after screening for all exclusion criteria will be randomized to procedure after or before transfusion of blood products and will be assessed the safety of procedure related bleed and need of intervention post procedure if any
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Low Cut Off
EXTEM CT\>80sec, CL130\<50% FIBTEM- Mcf\>8
ROTEM
ROTEM Tests
High Cut Off
EXTEM CT\>100sec, CL130\<40% FIBTEM- Mcf\<6
ROTEM
ROTEM Tests
On demand
No pre procedure blood products transfusions will be given. Transfusions will be given after the procedure if any bleeding complications occur
No interventions assigned to this group
Interventions
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ROTEM
ROTEM Tests
Eligibility Criteria
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Inclusion Criteria
2. Planned to undergo invasive procedures
3. Severe Coagulopathy- INR\>2.0 or Platelets \<30k or Fibrinogen\<100mg/dl .
Exclusion Criteria
2. Bleeding in past 48 hours before procedure
3. Antiplatelet or anticoagulant therapy ( stopped \< 7 days before)
18 Years
75 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ILBS-ACLF-21
Identifier Type: -
Identifier Source: org_study_id
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