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

数据管理中心--ORG-10172中风试验

• 批准号: 3414395
• 负责人: ROBERT F WOOLSON
• 金额: $ 39.15万
• 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/3414395
• 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.

为随机试验申请数据管理中心(DMC) 类肝素(ORG 10172)在急性或进展性缺血性中风中的作用。这个 这项研究的临床方面记录在一份平行的提案中。 由Harold P.Adams，Jr.，M.D.提交。数据管理中心将 在这项临床试验的过程中发挥了许多作用。在……里面 除了与临床首席研究员Dr。 Harold P.Adams，DMC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有效性， 并提供生物统计咨询和数据分析。整体而言 这项临床试验的目的是测试类肝素的能力， ORG 10172，以改善急性缺血性中风患者的预后。这个 临床试验是多中心的， 随机、双盲、安慰剂对照研究。比较 结果将使用格拉斯哥结果量表，Barthel指数， 以及随机化后7天和3个月的死亡率。这个 DMC将协助制定操作手册，a 由公契及临床部联合拟备的文件 由亚当斯博士指导的协调中心(CCC)。数据将会是计算机 在参与的临床中心输入，然后转移到DMC 通过PC机与PC机进行通信。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。虽然主要的统计分析将涉及 格拉斯哥结果量表和Barthel指数，其他分析将 根据美国国立卫生研究院对恶化的改善情况进行评估 卒中评分评估。