Clinical Trial: Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: German Multicenter EPO Stroke Trial (Phase II/III)
Brief Summary: The purpose of this randomized, double-blind, placebo-controlled multicenter study is to determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment on functional outcome up to a follow-up of 90 days.
Detailed Summary:
Sponsor: Max-Planck-Institute of Experimental Medicine
Current Primary Outcome: Neurological/functional outcome as measured by the Barthel Index (BI) [ Time Frame: day 90 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Modified Rankin Scale (mRS) responder [ Time Frame: day 90 ]
- Barthel Index (BI) [ Time Frame: day 30 ]
- mRS [ Time Frame: day30, day 90 ]
- NIH Stroke Scale [ Time Frame: day 1, 3, 7, 30, 90 ]
- Proportion of subjects with minimal disability (mRS 0-1) [ Time Frame: day 30, day 90 ]
- All-cause mortality [ Time Frame: day 90 ]
- Mortality directly related to stroke [ Time Frame: day 90 ]
- Proportion of subjects with BI >= 95 [ Time Frame: day 30, day 90 ]
- Proportion of subjects with BI=100 [ Time Frame: day 30, day 90 ]
- Proportion of subjects with neurological recovery [ Time Frame: day 3, 7, 30, 90 ]
- Distribution of mRS scores [ Time Frame: day 30, day 90 ]
- Distribution of BI scores [ Time Frame: day 30, day 90 ]
- Distribution of NIH Stroke Scale scores [ Time Frame: day 30, day 90 ]
- Serum level of glial damage markers S100B and GFAP [ Time Frame: day 1, 2, 3, 4, 7 ]
- Lesion size (MRI DWI, flair) [ Time Frame: day 1, day 7 ]
- Overall survival [ Time Frame: day 90 ]
- Late recovery index (BI day 90 versus BI day 30) [ Time Frame: day 30 to day 90 ]
Original Secondary Outcome:
- Modified Rankin Scale (mRS) responder [ Time Frame: day 90 ]
- Barthel Index (BI) [ Time Frame: day 30 ]
- mRS [ Time Frame: day30, day 90 ]
- NIH Stroke Scale [ Time Frame: day 1, 3, 7, 30, 90 ]
- Proportion of subjects with minimal disability (mRS 0-1) [ Time Frame: day 30, day 90 ]
- All-cause mortality [ Time Frame: day 90 ]
- Mortality directly related to stroke [ Time Frame: day 90 ]
- Proportion of subjects with BI >= 95 [ Time Frame: day 30, day 90 ]
- Proportion of subjects with BI=100 [ Time Frame: day 30, day 90 ]
- Proportion of subjects with neurological recovery [ Time Frame: day 3, 7, 30, 90 ]
- Distribution of mRS scores [ Time Frame: day 30, day 90 ]
- Distribution of BI scores [ Time Frame: day 30, day 90 ]
- Distribution of NIH Stroke Scale scores [ Time Frame: day 30, day 90 ]
- Serum level of glial damage markers S100B and GFAP [ Time Frame: day 1, 2, 3, 4, 7 ]
- Lesion size (MRI DWI, flair) [ Time Frame: day 1, day 7 ]
- Overall survival [ Time Frame: day 90 ]
Information By: Max-Planck-Institute of Experimental Medicine
Dates:
Date Received: January 17, 2008
Date Started: January 2003
Date Completion:
Last Updated: October 21, 2008
Last Verified: September 2008