High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cere… (NCT06515145) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema
India60 participantsStarted 2025-12-01
Plain-language summary
In this prospective randomized controlled trial Investigator aim to evaluate the impact of high versus standard volume plasma-exchange in patients with acute liver failure with cerebral edema and clinical outcomes. ALF who meet the inclusion and exclusion criteria within the first 12 hours will be randomized into two groups
Interventional - High-volume plasma exchange Active Comparator - Standard volume plasma exchange
Expected outcome of the project-.
1. Primary end points: Time to improvement in cerebral edema
2. Secondary end points:
To study the adverse events of therapy (volume overload, pulmonary complications, allergic reactions) etc.
Transplant-free survival at day 21
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Age \<18 or \> 70 years
. HCC
. Active untreated Sepsis/DIC
. Hemodynamic instability non-responsive to initial fluid resuscitation with norepinephrine \>0.1 ug/kg/min
. Post-resection and malignancy related liver failure
. Coma of non-hepatic origin
. Patients with uncontrolled infection
. Patients with pulmonary involvement with Pa02/Fio2 ratio below 200.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to improvement in cerebral edema
Timeframe: 7 Days
Trial details
NCT IDNCT06515145
SponsorInstitute of Liver and Biliary Sciences, India