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| Sponsor: | University of Miami |
|---|---|
| Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) University of Calgary Medical University of South Carolina Neurological Emergencies Treatment Trials Network (NETT) |
| Information provided by: | University of Miami |
| ClinicalTrials.gov Identifier: | NCT00235495 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Ischemic Stroke |
Biological: human serum albumin infusion Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Phase III Randomized Multicenter Clinical Trial Of High-Dose Human Albumin Therapy For Neuroprotection In Acute Ischemic Stroke |
| Estimated Enrollment: | 1100 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Treatment with 25% Albumin, 2.0 g/kg
|
Biological: human serum albumin infusion
human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset
|
|
2: Placebo Comparator
Treatment with same volume of normal saline
|
Biological: human serum albumin infusion
human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset
Drug: placebo
equivalent volume of saline control
|
Human serum albumin, at 2 g/kg, 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 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 team's thorough review of the Part-1 safety data and were designed to optimize safety going forward.]
Eligibility| Ages Eligible for Study: | 18 Years to 83 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Myron D Ginsberg, MD | 305 243 6103 | mginsberg@med.miami.edu |
| Contact: Michael D. Hill, MD MSc | 403 944 8065 | michael.hill@albertahealthservices.ca |
Show 25 Study Locations| Study Chair: | Myron D. Ginsberg, MD | University of Miami |
| Principal Investigator: | Michael D. Hill, MD MSc | University of Calgary |
| Principal Investigator: | Yuko Y Palesch, PhD | Medical University of South Carolina |
More Information
| Responsible Party: | University of Miami ( Myron D. Ginsberg, MD, Principal Investigator ) |
| Study ID Numbers: | NIH NINDS 5U01 NS040406-08, NIH NINDS 1U01 NS054630 |
| Study First Received: | September 14, 2005 |
| Last Updated: | February 5, 2010 |
| ClinicalTrials.gov Identifier: | NCT00235495 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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stroke |
|
Pathologic Processes Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Brain Ischemia |
Central Nervous System Diseases Cardiovascular Diseases Brain Infarction Ischemia Brain Diseases Cerebrovascular Disorders |