Acute Liver FailureNCT06831643
Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure
A study testing Standard Medical treatment and Therapeutic Plasma Excahnge in people with Acute Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Acute liver failure is a multisystem disorder characterized by a syndrome of jaundice, coagulopathy, and encephalopathy with high mortality in the absence of liver transplantation. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Acute Liver Failure
- What is being tested?
- Standard Medical treatment and Therapeutic Plasma Excahnge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 17 Feb 2025to 31 Dec 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 3 years to 18 years
- Fulfilling PALFSG definition (J Pediatr. 2006 May;148(5):652-658).
- Baseline INR ≥ 2.5, and increasing INR (any value) and/or worsening hepatic. encephalopathy (> 1 grade change) after 6 to 12 hours of standard medical therapy.
Who cannot join
- Disseminated intravascular coagulation
- Marked hemodynamic instability requiring a high dose of vasopressors (norepinephrine >0.5 mcg/kg/min)
- Signs of irreversible brain injury
- Any severe cardio-pulmonary pre-existing disease
- Septic Shock
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
New Delhi, National Capital Territory of Delhi, 110070
Dr Ashray S Patel, MD, 01146300000, patel1995ash@gmail.com
About this study
Official title: Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure - A Pilot Randomized Control Trial
Acute liver failure is a multisystem disorder characterized by a syndrome of jaundice, coagulopathy, and encephalopathy with high mortality in the absence of liver transplantation. The pathogenesis of multiorgan failure (MOF) in ALF has been attributed to the release of damage-associated molecular patterns (DAMPs) from injured hepatic cells and microbial pathogen-associated molecular patterns (PAMPs) in the presence of superimposed infection or bacterial translocation.The innate immune cells activated by PAMPs and DAMPs produce pro-inflammatory cytokines [interleukin (IL)-6, IL-1b, IL-8, tumor necrosis factor-alpha (TNF-a)]. Studies indicate that the removal of inflammatory mediators appears to play a role in the treatment of ALF and are removed by some apheresis techniques. Hence therapeutic exchange (TPE) has been used as adjunct or standalone therapy for bridging patients to recovery or LT. TPE to treat liver failure involves two steps-removal of plasma from a patient with liver failure and replacing this with equal volume of fluid; in view of the coagulopathy seen in liver failure patients, the preferred fluid for replacement is fresh frozen plasma. Different doses of PLEX have been used to treat liver failure patients with high, standard or low volume PLEX, to treat ALF. Presently American Apheresis Society guidelines consider High Volume TPE (HV-TPE) as first line the management of ALF. But HV-TPE, apart from strain on blood bank resources (large volumes of fresh frozen plasma needed), also carries risk of transfusion associated acute lung complications, risk of blood borne virus infection, and so on make the use of low-volume PLEX attractive compared to high-volume PLEX. Hence this study is being carried out to consider the safety and efficacy of standard volume plasma exchange (SV-TPE) vs. HV-TPE in Pediatric ALF.
Read the detailed description
Aim: To study the efficacy in terms of the native liver survival, of standard volume plasma exchange as compared to high volume plasma exchange in Pediatric ALF.
Study Design: Open label pilot Randomized Control trial. Sample size: Time bound. All cases presenting during the study period will be included in the study.
Standard Medical Therapy:
- All patients are were managed by a multidisciplinary team at Live Coma ICU.
- Intubation and ventilation were undertaken for standard indications in addition to the development of grade 3 encephalopathy or evidence of cerebral edema
- Ventilation was managed by fentanyl and propofol along with the use of atracurium for paralysis wherever required.
- Hemodynamics, ONSD and TCD are monitored routinely.
- All patients received N-acetylcysteine.
- Neuro-protective measures such as hypertonic saline, head end elevation, minimal stimulation, propofol and thiopentone infusion are followed as per protocol.
- Anti-ammonia measures like sodium benzoate, CRRT as well started as per protocol.
- CRRT is done for routine renal indications, hyperlactetmia, hyperammonemia.
- Conditions
- Acute Liver Failure
- Being tested
- Standard Medical treatment, Therapeutic Plasma Excahnge
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical treatmentDrug
Standard Medical treatment
Therapeutic Plasma ExcahngeBiological
Therapeutic Plasma Excahnge
| Study group | Role | What they receive |
|---|---|---|
| SV-TPE group | Experimental | SV-TPE group Receives: Drug: Standard Medical treatment; Biological: Therapeutic Plasma Excahnge |
| HV- TPE group | Active comparator | HV- TPE group Receives: Drug: Standard Medical treatment; Biological: Therapeutic Plasma Excahnge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Native liver survival at day 21, in patients receiving standard volume (1.3-1.5 times plasma volume) therapeutic plasma exchange and those receiving high volume (2-2.2 times plasma volume) therapeutic plasma exchange in children with acute.
Measured: Day 21
Secondary outcomes (15)
Clinical parameters:Grades of Hepatic Encephalopathy from day 0 to day 4.
Measured: Day 0,Day1,Day2,day3,Day 4
Clinical parameters: Optic Nerve Sheet Diameter (Left/Right) from day 0 to day 4.
Measured: Day 0,Day1,Day2,day3,Day 4
Clinical parameters: Mean arterial pressure from day 0 to day 4.
Measured: Day 0,Day1,Day2,day3,Day 4
Proportion of patients with change in Liver Function test from day 0 to day 4.
Measured: Day 0,Day1,Day2,day3,Day 4
Biochemical parameters: International normalized ratio from day 0 to day 4.
Measured: Day 0,Day1,Day2,day3,Day 4
Biochemical parameters:Arterial ammonia from day 0 to day 4.
Measured: Day 0,Day1,Day2,day3,Day 4
Biochemical parameters: Arterial lactate from day 0 to day 4.
Measured: Day 0,Day1,Day2,day3,Day 4
Patient with change in Cytokines level at day 0 and day 3.
Measured: Day 0 & Day 3
Impact on other factors at day 0 and 3: Growth Factors (G-CSF).
Measured: Day 0 & Day 3
Impact on other factors at day 0 and 3: Damage Associated Molecular Pattern (DAMPS) (S100B, HMGB1).
Measured: Day 0 & Day 3
Impact on other factors at day 0 and 3: Von Willebrand Factor.
Measured: Day 0 & Day 3
Adverse effects in both groups
Measured: Within Day 21
Duration of mechanical ventilation & ICU stay.
Measured: Within Day 21
Mortality
Measured: Within Day 21
Number of participants with Liver Transplant
Measured: Within Day 21
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 start17 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06831643
- Sponsor's protocol ID
- ILBS-ALF-08
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2025
- Last updated
- 6 Jan 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure - A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06831643
- Acronym / sponsor ID
- ILBS-ALF-08
- Conditions
- Acute Liver Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 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.
Acute liver failure is a multisystem disorder characterized by a syndrome of jaundice, coagulopathy, and encephalopathy with high mortality in the absence of liver transplantation. The pathogenesis of multiorgan failure (MOF) in ALF has been attributed to the release of damage-associated molecular patterns (DAMPs) from injured hepatic cells and microbial pathogen-associated molecular patterns (PAMPs) in the presence of superimposed infection or bacterial translocation.The innate immune cells activated by PAMPs and DAMPs produce pro-inflammatory cytokines [interleukin (IL)-6, IL-1b, IL-8, tumor necrosis factor-alpha (TNF-a)]. Studies indicate that the removal of inflammatory mediators appears to play a role in the treatment of ALF and are removed by some apheresis techniques. Hence therapeutic exchange (TPE) has been used as adjunct or standalone therapy for bridging patients to recovery or LT. TPE to treat liver failure involves two steps-removal of plasma from a patient with liver failure and replacing this with equal volume of fluid; in view of the coagulopathy seen in liver failure patients, the preferred fluid for replacement is fresh frozen plasma. Different doses of PLEX have been used to treat liver failure patients with high, standard or low volume PLEX, to treat ALF. Presently American Apheresis Society guidelines consider High Volume TPE (HV-TPE) as first line the management of ALF. But HV-TPE, apart from strain on blood bank resources (large volumes of fresh frozen plasma needed), also carries risk of transfusion associated acute lung complications, risk of blood borne virus infection, and so on make the use of low-volume PLEX attractive compared to high-volume PLEX. Hence this study is being carried out to consider the safety and efficacy of standard volume plasma exchange (SV-TPE) vs. HV-TPE in Pediatric ALF.
Detailed description
Aim: To study the efficacy in terms of the native liver survival, of standard volume plasma exchange as compared to high volume plasma exchange in Pediatric ALF.
Study Design: Open label pilot Randomized Control trial. Sample size: Time bound. All cases presenting during the study period will be included in the study.
Standard Medical Therapy:
- All patients are were managed by a multidisciplinary team at Live Coma ICU.
- Intubation and ventilation were undertaken for standard indications in addition to the development of grade 3 encephalopathy or evidence of cerebral edema
- Ventilation was managed by fentanyl and propofol along with the use of atracurium for paralysis wherever required.
- Hemodynamics, ONSD and TCD are monitored routinely.
- All patients received N-acetylcysteine.
- Neuro-protective measures such as hypertonic saline, head end elevation, minimal stimulation, propofol and thiopentone infusion are followed as per protocol.
- Anti-ammonia measures like sodium benzoate, CRRT as well started as per protocol.
- CRRT is done for routine renal indications, hyperlactetmia, hyperammonemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SV-TPE group | Experimental | Drug: Standard Medical treatment, Biological: Therapeutic Plasma ExcahngeSV-TPE group |
| HV- TPE group | Active comparator | Drug: Standard Medical treatment, Biological: Therapeutic Plasma ExcahngeHV- TPE group |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age: 3 years to 18 years
- Fulfilling PALFSG definition (J Pediatr. 2006 May;148(5):652-658).
- Baseline INR ≥ 2.5, and increasing INR (any value) and/or worsening hepatic. encephalopathy (> 1 grade change) after 6 to 12 hours of standard medical therapy.
Key exclusion criteria (5 listed)
- Disseminated intravascular coagulation
- Marked hemodynamic instability requiring a high dose of vasopressors (norepinephrine >0.5 mcg/kg/min)
- Signs of irreversible brain injury
- Any severe cardio-pulmonary pre-existing disease
- Septic Shock
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 |
|---|---|---|
| Standard Medical treatmentStandard Medical treatment | Drug | HV- TPE group, SV-TPE group |
| Therapeutic Plasma ExcahngeTherapeutic Plasma Excahnge | Biological | HV- TPE group, SV-TPE group |
Primary outcome
Native liver survival at day 21, in patients receiving standard volume (1.3-1.5 times plasma volume) therapeutic plasma exchange and those receiving high volume (2-2.2 times plasma volume) therapeutic plasma exchange in children with acute.
Time frame: Day 21
15 secondary outcomes
Clinical parameters:Grades of Hepatic Encephalopathy from day 0 to day 4.
Time frame: Day 0,Day1,Day2,day3,Day 4
Clinical parameters: Optic Nerve Sheet Diameter (Left/Right) from day 0 to day 4.
Time frame: Day 0,Day1,Day2,day3,Day 4
Clinical parameters: Mean arterial pressure from day 0 to day 4.
Time frame: Day 0,Day1,Day2,day3,Day 4
Proportion of patients with change in Liver Function test from day 0 to day 4.
Time frame: Day 0,Day1,Day2,day3,Day 4
Biochemical parameters: International normalized ratio from day 0 to day 4.
Time frame: Day 0,Day1,Day2,day3,Day 4
Biochemical parameters:Arterial ammonia from day 0 to day 4.
Time frame: Day 0,Day1,Day2,day3,Day 4
Biochemical parameters: Arterial lactate from day 0 to day 4.
Time frame: Day 0,Day1,Day2,day3,Day 4
Patient with change in Cytokines level at day 0 and day 3.
Time frame: Day 0 & Day 3
Impact on other factors at day 0 and 3: Growth Factors (G-CSF).
Time frame: Day 0 & Day 3
Impact on other factors at day 0 and 3: Damage Associated Molecular Pattern (DAMPS) (S100B, HMGB1).
Time frame: Day 0 & Day 3
Impact on other factors at day 0 and 3: Von Willebrand Factor.
Time frame: Day 0 & Day 3
Adverse effects in both groups
Time frame: Within Day 21
Duration of mechanical ventilation & ICU stay.
Time frame: Within Day 21
Mortality
Time frame: Within Day 21
Number of participants with Liver Transplant
Time frame: Within Day 21
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 6 Jan 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 Standard Medical treatment and Therapeutic Plasma Excahnge in people with Acute 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 5 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 6 Jan 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 Ashray S Patel, MD (01146300000, patel1995ash@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Native liver survival at day 21, in patients receiving standard volume (1.3-1.5 times plasma volume) therapeutic plasma exchange and those receiving high volume (2-2.2 times plasma volume) therapeutic plasma exchange in children with acute. (time frame: Day 21). 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 6 Jan 2026.