Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 11:02 PM
Study NCT ID:
NCT00224705
Status:
COMPLETED
Last Update Posted:
2011-02-17
First Post:
2005-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The MARS® Albumin Dialysis System in Patients With Fulminant and Subfulminant Hepatic Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D047508', 'term': 'Massive Hepatic Necrosis'}, {'id': 'D017114', 'term': 'Liver Failure, Acute'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D056486', 'term': 'Chemical and Drug Induced Liver Injury'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2005-09-19', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient survival at six months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Patient survival at six months without neurological sequelae', 'timeFrame': '6 months'}, {'measure': 'Patient survival at 1 year', 'timeFrame': 'during one year'}, {'measure': 'Graft survival at six months and 1 year', 'timeFrame': 'at 6 months and at one year'}, {'measure': 'Number of patients who improve their liver function and no longer need a transplant in each stage of the trial', 'timeFrame': 'during one year'}, {'measure': 'Hospital mortality before the transplant', 'timeFrame': 'during one year'}, {'measure': 'Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale)', 'timeFrame': 'during one year'}, {'measure': 'Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function', 'timeFrame': 'during one year'}, {'measure': 'Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections)', 'timeFrame': 'during one year'}, {'measure': 'Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant', 'timeFrame': 'during one year'}, {'measure': 'duration of hospitalisation', 'timeFrame': 'during one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Albumin dialysis', 'MARS system', 'Extracorporeal artificial liver support', 'Fulminant hepatitis', 'Subfulminant hepatitis', 'Acute liver failure'], 'conditions': ['Hepatitis']}, 'referencesModule': {'references': [{'pmid': '12950955', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24126646', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. Reducing the number of patients who die before a graft is available\n2. Increasing the chances of survival without a liver transplant\n3. Reducing the pre- and post-operative mortality in transplant patients', 'detailedDescription': 'Patients with fulminant or subfulminant hepatitis with either an indication or a relative contraindication to a liver transplantation, are randomized to two groups:\n\n1. A group treated with the conventional medical intensive treatment (including the hemodialysis techniques, continuous veno-venous hemofiltration or hemodiafiltration, if necessary) and the gold standard surgical treatment (liver transplantation) compared to\n2. A group receiving, in addition to the conventional medical intensive treatment, albumin dialysis using the MARS device and the gold standard surgical treatment (liver transplantation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation\n\nExclusion Criteria:\n\n* Sepsis severe not controlled\n* Haemorrhage activates not controlled\n* Clinical Obviousness of disseminated intravascular coagulation\n* Severe Pathology cardiopulmonary (NYHA \\> or = 2)\n* Pregnancy, breast feeding\n* Average blood Pressure \\< 40 mmHg more than 10 minutes in spite of a support by the inotrope\n* Nonhepatic coma of origin\n* Cholestases extra-hepatitic\n* Antecedents of heavy surgery in the 4 previous weeks or surgical problems unsolved\n* Absolute counter-indication with hepatic transplantation (extra Neoplasia hepatic evolutionary, irreversible cerebral Attack, irreversible multi-visceral Failure, visceral tares contra-indicating the transplantation)\n* Positive serology HIV\n* Hepatic Demonstrations of the malignant hemopathies\n* Participation in another therapeutic test in the 4 previous weeks'}, 'identificationModule': {'nctId': 'NCT00224705', 'briefTitle': 'The MARS® Albumin Dialysis System in Patients With Fulminant and Subfulminant Hepatic Failure', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure', 'orgStudyIdInfo': {'id': 'P030423'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Molecular Adsorbent Recirculating System (MARS®)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Hôpital Paul Brousse', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Faouzi SALIBA, Pr, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cecile JOURDAIN', 'oldOrganization': 'Department of Clinical Research of developpement'}}}}