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:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Patients with fulminant or subfulminant hepatitis with either an indication or a relative contraindication to a liver transplantation, are randomized to two groups:
1. 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
2. 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).
1. 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
2. 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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: