The MARS® Albumin Dialysis System in Patients With Fulminant and Subfulminant Hepatic Failure (NCT00224705) | Clinical Trial Compass
CompletedPhase 3
The MARS® Albumin Dialysis System in Patients With Fulminant and Subfulminant Hepatic Failure
France110 participantsStarted 2004-08
Plain-language summary
The purpose of this study is to improve the survival rate of those patients with acute fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system by:
1. Reducing the number of patients who die before a graft is available
2. Increasing the chances of survival without a liver transplant
3. Reducing the pre- and post-operative mortality in transplant patients
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.
Inclusion Criteria:
* Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation
Exclusion Criteria:
* Sepsis severe not controlled
* Haemorrhage activates not controlled
* Clinical Obviousness of disseminated intravascular coagulation
* Severe Pathology cardiopulmonary (NYHA \> or = 2)
* Pregnancy, breast feeding
* Average blood Pressure \< 40 mmHg more than 10 minutes in spite of a support by the inotrope
* Nonhepatic coma of origin
* Cholestases extra-hepatitic
* Antecedents of heavy surgery in the 4 previous weeks or surgical problems unsolved
* Absolute counter-indication with hepatic transplantation (extra Neoplasia hepatic evolutionary, irreversible cerebral Attack, irreversible multi-visceral Failure, visceral tares contra-indicating the transplantation)
* Positive serology HIV
* Hepatic Demonstrations of the malignant hemopathies
* Participation in another therapeutic test in the 4 previous weeks
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.