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The purpose of this study is to improve the survival rate of those patients with acute fulminant hepatitis through treatment with the MARSĀ® extra-corporal liver-purification system by:
Patients with fulminant or subfulminant hepatitis with either an indication or a relative contraindication to a liver transplantation, are randomized to two groups:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular Adsorbent Recirculating System (MARSĀ®) | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Patient survival at six months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient survival at six months without neurological sequelae | 6 months | |
| Patient survival at 1 year | during one year | |
| Graft survival at six months and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faouzi SALIBA, Pr, MD, PhD | Assistance Publique - HƓpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HƓpital Paul Brousse | Villejuif | 94800 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12950955 | Background | Novelli G, Rossi M, Pretagostini R, Novelli L, Poli L, Ferretti G, Iappelli M, Berloco P, Cortesini R. A 3-year experience with Molecular Adsorbent Recirculating System (MARS): our results on 63 patients with hepatic failure and color Doppler US evaluation of cerebral perfusion. Liver Int. 2003;23 Suppl 3:10-5. doi: 10.1034/j.1478-3231.23.s.3.4.x. | |
| 24126646 |
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| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D047508 | Massive Hepatic Necrosis |
| D017114 | Liver Failure, Acute |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D056486 | Chemical and Drug Induced Liver Injury |
| D017093 | Liver Failure |
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| at 6 months and at one year |
| Number of patients who improve their liver function and no longer need a transplant in each stage of the trial | during one year |
| Hospital mortality before the transplant | during one year |
| Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale) | during one year |
| Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function | during one year |
| Evaluation of the safety parameters of the MARSĀ® system (thromboembolism, risk of haemorrhage and infections) | during one year |
| Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant | during one year |
| duration of hospitalisation | during one year |
| Saliba F, Camus C, Durand F, Mathurin P, Letierce A, Delafosse B, Barange K, Perrigault PF, Belnard M, Ichai P, Samuel D. Albumin dialysis with a noncell artificial liver support device in patients with acute liver failure: a randomized, controlled trial. Ann Intern Med. 2013 Oct 15;159(8):522-31. doi: 10.7326/0003-4819-159-8-201310150-00005. |
| D048550 | Hepatic Insufficiency |