This request for a Data Management Center (DMC) for the randomized trial of a heparinoid (ORG 10172) in acute or progressing ischemic stroke. The clinical aspects of this research are documented in a parallel proposal submitted by Harold P. Adams, jr., M.D. The Data Management Center will serve a number of functions during the course of this clinical trial. In addition to collaborating with the clinical principal investigator, Dr. Harold P. Adams, the DMC will provide data management services, assist with quality control, assist with communication between the clinical trial components, assist in monitoring safety and efficacy of the study drug, and provide biostatistical consultation and data analysis. The overall purpose of this clinical trial is to test the ability of the heparinoid, ORG 10172, to improve outcome in patients with acute ischemic stroke. The clinical trial is a multi-center, randomized, double blind, placebo controlled study. Comparisons of outcome will be made using the Glasgow Outcome Scale, the Barthel Index, and mortality at both seven days and three months post-randomization. The DMC will assist with the development of the Manual of Operations, a document which will be jointly prepared by the DMC and the Clinical Coordinating Center (CCC) directed by Dr. Adams. Data will be computer entered at the Participating Clinical Centers, then transferred to the DMC through PC to PC communication. Data at the DMC will be maintained as a relational data base on the VAX/VMS system using the ORACLE data base management system. While the primary statistical analyses will involve the Glasgow Outcome Scale and the Barthel Index, additional analyses will also be performed to evaluate improvement of deterioration based on NIH stroke Scale assessments.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
5R01NS027960-05
Application #
2266685
Study Section
Neurology A Study Section (NEUA)
Project Start
1990-01-01
Project End
1994-12-31
Budget Start
1994-01-01
Budget End
1994-12-31
Support Year
5
Fiscal Year
1994
Total Cost
Indirect Cost
Name
University of Iowa
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
041294109
City
Iowa City
State
IA
Country
United States
Zip Code
52242
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Johnston, S Claiborne; Leira, Enrique C; Hansen, Michael D et al. (2003) Early recovery after cerebral ischemia risk of subsequent neurological deterioration. Ann Neurol 54:439-44
Wilterdink, J L; Bendixen, B; Adams Jr, H P et al. (2001) Effect of prior aspirin use on stroke severity in the trial of Org 10172 in acute stroke treatment (TOAST). Stroke 32:2836-40
Bruno, A; Biller, J; Adams Jr, H P et al. (1999) Acute blood glucose level and outcome from ischemic stroke. Trial of ORG 10172 in Acute Stroke Treatment (TOAST) Investigators. Neurology 52:280-4
Chaturvedi, S; Adams Jr, H P; Woolson, R F (1999) Circadian variation in ischemic stroke subtypes. Stroke 30:1792-5
Adams Jr, H P; Davis, P H; Leira, E C et al. (1999) Baseline NIH Stroke Scale score strongly predicts outcome after stroke: A report of the Trial of Org 10172 in Acute Stroke Treatment (TOAST). Neurology 53:126-31

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