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

数据管理中心--ORG-10172中风试验

• 批准号: 2266685
• 负责人: ROBERT F WOOLSON
• 金额: $ 40.24万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-01-01 至 1994-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2266685
• 关键词: brain disorder chemotherapy; cerebral ischemia /hypoxia; clinical trials; human subject; human therapy evaluation; information systems; placebos; statistics /biometry; stroke

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.

随机试验的数据管理中心（DMC）申请 类肝素（ORG 10172）治疗急性或进展性缺血性卒中。 的 这项研究的临床方面记录在一个平行的提案中 小哈罗德·P·亚当斯提交，M.D. 数据管理中心将 在本临床试验过程中发挥多种功能。 在 除了与临床主要研究者合作外， DMC Harold P.亚当斯将提供数据管理服务，协助 配合质量控制，协助临床试验之间的沟通 成分，协助监测研究药物的安全性和疗效， 并提供生物统计咨询和数据分析。 整体 该临床试验的目的是测试类肝素的能力， ORG 10172，改善急性缺血性卒中患者的结局。 的 临床试验是多中心的， 随机、双盲、安慰剂对照研究。 比较 将使用格拉斯哥结局量表，Barthel指数， 以及随机分组后7天和3个月的死亡率。 的 灾害管理委员会将协助编写《业务手册》， 将由DMC和临床试验机构共同编制的文件 协调中心（CCC）由亚当斯博士指导。 数据将被计算机 在参与临床中心录入，然后转移至DMC 通过PC到PC的通信。 DMC中的数据将作为 在VAX/VMS系统上使用ORACLE数据库的关系数据库 管理系统. 虽然主要统计分析将涉及 格拉斯哥结局量表和Barthel指数，其他分析将 也可根据NIH评估恶化的改善情况 卒中量表评估。