An interventional study of ROTEM in Acute-On-Chronic Liver Failure, sponsored by Institute of Liver and Biliary Sciences, India. Recruiting at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Diagnostic
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Among 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India — 17 open to participants now, 17 under way, 2 of them phase 3. Acute-On-Chronic Liver Failure · Institute of Liver and Biliary Sciences, India.
Among the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India, this one is the 2nd largest by planned enrollment of the 28 interventional ones that give a count, is one of 4 that started in 2025, is one of 23 with no phase, reaches primary completion later than 8 of the 16 other live ones, and was the 30th registered.
167 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 62 are open to participants now.
Browse Acute-On-Chronic Liver Failure studies →17 of the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India are open now, in 1 country. Recruiting first, the newest first:
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18+
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–65
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–65
Institute of Liver and Biliary Sciences, India
Ages 18+
Institute of Liver and Biliary Sciences, India
Ages 18+
By country, each count listing its studies:
Of the 32 Acute-On-Chronic Liver Failure studies recruiting now, 11 (34%) set no upper age limit and 15 (47%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 3
First in 2011; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 790 is above the median of 73 across 96 interventional studies indexed under Acute-On-Chronic Liver Failure.
Median enrollment 95 across the 28 interventional studies, 114 across the 11 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
4 of the studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06818565Institute of Liver and Biliary Sciences, IndiaComparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections. | 2026-12-31 |
| NCT07184866Institute of Liver and Biliary Sciences, IndiaVitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial | 2027-07 |
| NCT07178366Institute of Liver and Biliary Sciences, IndiaDouble Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) | 2027-07 |
| NCT07422948Institute of Liver and Biliary Sciences, IndiaEfficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure. | 2027-08-30 |
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Among the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India, from their registry updates:
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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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EXTEM CT\>80sec, CL130\<50% FIBTEM- Mcf\>8
Diagnostic Test: ROTEM
EXTEM CT\>100sec, CL130\<40% FIBTEM- Mcf\<6
Diagnostic Test: ROTEM
No pre procedure blood products transfusions will be given. Transfusions will be given after the procedure if any bleeding complications occur
ROTEM Tests
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)
Time frame: Day 28
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Aug 2026, 17 months after the start.
Of 32 interventional studies with no phase under Acute-On-Chronic Liver Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 50. This study's planned 17 months is below that.
How these figures are worked out, and which studies are left out of them.
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