Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287235
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2006-02-02
Brief Title:
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System MARS
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
A Prospective Controlled Study Of The Clinical Efficacy Of Albumin Dialysis Using The Molecular Adsorbent Recirculating System MARS For The Treatment Of Patients With Hepatic Encephalopathy
Status:
COMPLETED
Status Verified Date:
2017-04
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 primary objective of the study was to compare the efficacy safety and tolerability of Extracorporeal Albumin Dialysis ECAD using the Molecular Adsorbent Recirculating System MARS device in improving severe HE by 2 grades compared to Standard Medical Therapy SMT in patients with chronic End Stage Liver Disease ESLD during a 5 day study period
Detailed Description:
The trial was a two-group unblinded multicenter clinical trial Patients were randomized to receive either SMT or SMT plus five days MARS treatment The trial design called for patients to receive a baseline hepatic encephalopathy HE assessment on admission and at 12-hour intervals giving 10 HE measurements during treatment using a refinement adaptation of the Conn West Haven HE Criteria HE scoring system
Study Oversight
Has Oversight DMC:
None
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?:
None