Acute-On-Chronic Liver FailureNCT06831565
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 study testing ROTEM in people with Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- ROTEM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 790 participants
- Where
- 1 siteIndia
- Study dates
- 19 Mar 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis and ACLF ( as per definition)
- Planned to undergo invasive procedures
- Severe Coagulopathy- INR>2.0 or Platelets <30k or Fibrinogen<100mg/dl .
Who cannot join
- Ongoing bleeding
- Bleeding in past 48 hours before procedure
- Antiplatelet or anticoagulant therapy ( stopped < 7 days before)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Sanda Kavitha, MD, 01146300000, sandakavitha1001@gmail.com
About this study
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: A Randomized Controlled Trial
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.
Read the detailed description
Aim and Objective - To evaluate the efficacy and safety of relaxed threshold (compared to threshold) for blood product transfusion for invasive procedures in cirrhosis and ACLF patients.
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
- Acute-On-Chronic Liver Failure
- Being tested
- ROTEM
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEMDiagnostic test
ROTEM Tests
| Study group | Role | What they receive |
|---|---|---|
| Low Cut Off | Active comparator | EXTEM CT>80sec, CL130<50% FIBTEM- Mcf>8 Receives: Diagnostic Test: ROTEM |
| High Cut Off | Experimental | EXTEM CT>100sec, CL130<40% FIBTEM- Mcf<6 Receives: Diagnostic Test: ROTEM |
| On demand | No intervention | No pre procedure blood products transfusions will be given. Transfusions will be given after the procedure if any bleeding complications occur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with reduction in the amount of total components transfused in high cut off ROTEM compared to low cut off ROTEM in cirrhosis and ACLF patients.
High Cutoff defined as need of low blood transfusion products (CT->100sec,MCF<25,CLI30<40%,MCF -FIB<6mm) and Low Cut off defined as (CT ->80sec, MCF<35, CLI30<50%,MCF-FIB<6mm)
Measured: Day 28
Secondary outcomes (5)
Assess the impact of ROTEM on transfusion requirements.
Impact of standard ROTEM on transfusion requirements that is proportion Of FFP, PLATELETS,CRYO, PCC, FIBRINOGEN before procedure in cirrhosis and ACLF patients.
Measured: Day 28
Evaluate the incidence of bleeding events post procedure in Low cutoff.
Measured: Day 28
Mortality related with procedural bleeding in both groups.
Measured: Day 28
Proportion of the patient requiring procedural based treatment that is number of blood transfusions, angioembolization after post procedural bleed.
Measured: Day 28
To compare the rate of transfusion reactions in relaxed ROTEM vs standard ROTEM in cirrhosis and ACLF.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start19 Mar 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 790 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831565
- Sponsor's protocol ID
- ILBS-ACLF-21
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06831565
- Acronym / sponsor ID
- ILBS-ACLF-21
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 790 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim and Objective - To evaluate the efficacy and safety of relaxed threshold (compared to threshold) for blood product transfusion for invasive procedures in cirrhosis and ACLF patients.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Cut Off | Active comparator | Diagnostic Test: ROTEMEXTEM CT>80sec, CL130<50% FIBTEM- Mcf>8 |
| High Cut Off | Experimental | Diagnostic Test: ROTEMEXTEM CT>100sec, CL130<40% FIBTEM- Mcf<6 |
| On demand | No intervention | –No pre procedure blood products transfusions will be given. Transfusions will be given after the procedure if any bleeding complications occur |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cirrhosis and ACLF ( as per definition)
- Planned to undergo invasive procedures
- Severe Coagulopathy- INR>2.0 or Platelets <30k or Fibrinogen<100mg/dl .
Key exclusion criteria (3 listed)
- Ongoing bleeding
- Bleeding in past 48 hours before procedure
- Antiplatelet or anticoagulant therapy ( stopped < 7 days before)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTEMROTEM Tests | Diagnostic test | High Cut Off, Low Cut Off |
Primary outcome
Proportion of patients with reduction in the amount of total components transfused in high cut off ROTEM compared to low cut off ROTEM in cirrhosis and ACLF patients.
Time frame: Day 28
High Cutoff defined as need of low blood transfusion products (CT->100sec,MCF<25,CLI30<40%,MCF -FIB<6mm) and Low Cut off defined as (CT ->80sec, MCF<35, CLI30<50%,MCF-FIB<6mm)
5 secondary outcomes
Assess the impact of ROTEM on transfusion requirements.
Time frame: Day 28
Evaluate the incidence of bleeding events post procedure in Low cutoff.
Time frame: Day 28
Mortality related with procedural bleeding in both groups.
Time frame: Day 28
Proportion of the patient requiring procedural based treatment that is number of blood transfusions, angioembolization after post procedural bleed.
Time frame: Day 28
To compare the rate of transfusion reactions in relaxed ROTEM vs standard ROTEM in cirrhosis and ACLF.
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROTEM in people with Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Sanda Kavitha, MD (01146300000, sandakavitha1001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with reduction in the amount of total components transfused in high cut off ROTEM compared to low cut off ROTEM in cirrhosis and ACLF patients. (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.