DATA MANAGEMENT CENTER--TRIAL OF ORG-10172 IN STROKE

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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.