Acute Liver FailureNCT02719210
High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure
A study testing High Volume Plasma Exchange, Hypertonic 3% saline and Mannitol in people with Acute Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
All the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Liver Failure
- What is being tested?
- High Volume Plasma Exchange, Hypertonic 3% saline and Mannitol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2016to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children ≥ 10kg with ALF with INR ≥ 4 or INR ≥ 3 with Hepatic Encephalopathy.
Who cannot join
- Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin ≥ 2 and/or focus of active infection
- Refusal of consent or assent (annexure 3)
- Liver resections with liver failure
- Patients with clinical suspicion of irreversible brain injury
- Patients with acute kidney injury
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure-A Prospective Pilot Study.
All the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.
- Conditions
- Acute Liver Failure
- Being tested
- High Volume Plasma Exchange, Hypertonic 3% saline, Mannitol, Elective positive pressure ventilation
- 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.
High Volume Plasma ExchangeBiological
Hypertonic 3% salineDrug
MannitolDrug
Elective positive pressure ventilationDevice
| Study group | Role | What they receive |
|---|---|---|
| High Volume Plasma Exchange with Standard Treatment | Experimental | Not described Receives: Biological: High Volume Plasma Exchange |
| Standard Treatment | Active comparator | Standard Treatment is defined as anti raised Intra-cranial pressure
1. Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure).
2. Mannitol
3. Hypertonic 3% Saline Receives: Drug: Hypertonic 3% saline; Drug: Mannitol; Device: Elective positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free Survival.
Measured: 7 days
Transplant free survival
Measured: 30 days
Secondary outcomes (10)
Survival after liver transplant with or without High Volume Plasma Exchange.
Measured: 30 days post procedure
Incidence of organ dysfunction (other than liver and Central Nervous System).
Measured: 30 days
Number of organs (other than liver and CNS) affected in children with organ dysfunction.
Measured: 30 days
Incidence of High Volume Plasma Exchange related complications- Major/Minor.
Measured: within 1 month
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Measured: 0 day
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Measured: 5 days
Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.
Measured: 0 day
Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.
Measured: 5 day
Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in HVPE arm from baseline till within 24-hours of the last session of High Volume Plasma Exchange.
Measured: within 24-hours of the last session of High Volume Plasma Exchange
Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start1 Jan 2016
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Arti Pawaria, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719210
- Sponsor's protocol ID
- ILBS-ALF-02
- Status last verified
- May 2018
- First submitted
- 17 Feb 2016
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure-A Prospective Pilot Study.
- ClinicalTrials.gov ID
- NCT02719210
- Acronym / sponsor ID
- ILBS-ALF-02
- Conditions
- Acute Liver Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 25 Mar 2016 (estimated)
- 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.
All the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Volume Plasma Exchange with Standard Treatment | Experimental | Biological: High Volume Plasma Exchange |
| Standard Treatment | Active comparator | Drug: Hypertonic 3% saline, Drug: Mannitol, Device: Elective positive pressure ventilationStandard Treatment is defined as anti raised Intra-cranial pressure 1. Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure). 2. Mannitol 3. Hypertonic 3% Saline |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children ≥ 10kg with ALF with INR ≥ 4 or INR ≥ 3 with Hepatic Encephalopathy.
Key exclusion criteria (5 listed)
- Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin ≥ 2 and/or focus of active infection
- Refusal of consent or assent (annexure 3)
- Liver resections with liver failure
- Patients with clinical suspicion of irreversible brain injury
- Patients with acute kidney injury
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 |
|---|---|---|
| High Volume Plasma Exchange | Biological | High Volume Plasma Exchange with Standard Treatment |
| Hypertonic 3% saline | Drug | Standard Treatment |
| Mannitol | Drug | Standard Treatment |
| Elective positive pressure ventilation | Device | Standard Treatment |
Primary outcome
Transplant free Survival.
Time frame: 7 days
Transplant free survival
Time frame: 30 days
10 secondary outcomes
Survival after liver transplant with or without High Volume Plasma Exchange.
Time frame: 30 days post procedure
Incidence of organ dysfunction (other than liver and Central Nervous System).
Time frame: 30 days
Number of organs (other than liver and CNS) affected in children with organ dysfunction.
Time frame: 30 days
Incidence of High Volume Plasma Exchange related complications- Major/Minor.
Time frame: within 1 month
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Time frame: 0 day
Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.
Time frame: 5 days
Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.
Time frame: 0 day
Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.
Time frame: 5 day
Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in HVPE arm from baseline till within 24-hours of the last session of High Volume Plasma Exchange.
Time frame: within 24-hours of the last session of High Volume Plasma Exchange
Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days.
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
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Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
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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. This study is not recruiting at the moment.
Dr Arti Pawaria, MD principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Volume Plasma Exchange, Hypertonic 3% saline and Mannitol 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 1 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: finished, as of the sponsor's last update on 6 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant free Survival. (time frame: 7 days). The study lists 2 primary outcomes in all. 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 Dec 2018.