Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235495
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2005-09-14
Brief Title:
Albumin in Acute Ischemic Stroke Trial
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
A Phase III Randomized Multicenter Clinical Trial Of High-Dose Human Albumin Therapy For Neuroprotection In Acute Ischemic Stroke
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment halted by DSMB following interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALIAS
Brief Summary:
The goal of the trial is to determine whether human albumin administered within 5 hours of symptom onset improves the 3-month outcome of subjects with acute ischemic stroke
Detailed Description:
Human serum albumin at 2 gkg administered over 2 hours by intravenous infusion will be compared to placebo isovolumic normal saline among patients with acute ischemic stroke All patients will have a baseline stroke severity measured as NIH Stroke scale score 5 Patients will treated according to the best standard of care including concurrent treatment with intravenous or intra-arterial thrombolysis where appropriate The primary outcome will be determined at 3 months The primary hypothesis is that using the composite outcome of a modified Rankin score 0-1 or NIH stroke scale score 0-1 at 3 months or both the proportion of patients with improved outcomes will be greater by 10 or more in the active treatment group The current trial is termed Part 2 and incorporates revisions to the initial protocol that were instituted after the Data Safety Monitoring Board DSMB suspended subject recruitment because of a safety concern after 434 subjects had been enrolled The protocol revisions of Part 2 resulted from the study teams thorough review of the Part-1 safety data and were designed to optimize safety going forward
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20060233 | OTHER | Western IRB | httpsreporternihgovquickSearchU01NS054630 |
| U01NS054630 | NIH | None | None |
| NIH NINDS 5U01 NS040406-08 | OTHER | None | None |