Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 14
- 主要终点
- International Standards For Neurological Classification of Spinal Injury (ISNCSCI)
研究概览
简要总结
The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting de-identified data from patients admitted through the Emergency Department of a NACTN center at the time of injury with an initial (first time) spinal cord injury (SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months from the date of injury or long as medically indicated. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation. No intervention is given other than standard of care for spinal cord injury, intensive monitoring and frequent follow up care.
详细描述
The participating centers include:
University of Texas Health Science Center, Houston; University of Toronto, Toronto; University of Virginia, Charlottesville; University of Louisville, Louisville; University of Maryland, Baltimore; Walter Reed National Military Medical Center, Bethesda; Thomas Jefferson University, Philadelphia; University of Miami, Miami; Brooke Army Medical Center, Fort Sam Houston; Louisiana State University Health Sciences Center, New Orleans; Vanderbilt University Medical Center, Nashville; Medical College Wisconsin, Milwaukee; Duke University, Durham
The NACTN Clinical Coordinating Center is located at:
Houston Methodist Hospital, Houston
The Center for Biostatistics is located at:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient male or female > or equal to 18 years of age with first time spinal cord injury caused by trauma and has neurological deficit with paralysis (weakness) or loss of sensation (touch).
- •Has not received prior medical of surgical care for this injury at an intermediate hospital.
- •Must give informed consent
排除标准
- •Any patient or family refusing consent
结局指标
主要结局
International Standards For Neurological Classification of Spinal Injury (ISNCSCI)
时间窗: Pre-operative, Post-operative, 2 weeks, Discharge, 3 months, 6 months, 12 months, 36 months and 48 months
A neurological assessment and classification of a spinal cord injury
次要结局
未报告次要终点
研究者
Robert G. Grossman, MD
Professor, Department of Neurosurgery
The Methodist Hospital Research Institute