Spinal Cord Injury Registry - North American Clinical Trials Network
- Conditions
- Spinal Cord Injury
- Interventions
- Other: No Treatment Given
- Registration Number
- NCT00178724
- Lead Sponsor
- Robert G. Grossman, MD
- Brief Summary
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.
- Detailed Description
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:
Houston Methodist Hospital, Houston
The Data Management Center is located at:
University of Louisville, Louisville
Preliminary work has been completed on the selection of data elements, data collection protocols, case record form design, and the design of a computer system for clinical data management and data quality control.
In the first phase of the network, data will be collected on the natural history of SCI. Although there is considerable data in the literature about the natural history of SCI, current changes in treatment appear to be modifying the natural history. In particular very early surgery, including decompression of the spinal cord and vertebral stabilization with instrumentation appears, in some cases of SCI, to be improving outcomes.
No treatment is given other than standard of care for SCI. Data is collected in hopes to help SCI patients in the future.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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
- Any patient or family refusing consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No Treatment Given No Treatment Given Any male or female 18 years or older admitted to a NACTN hospital, at the time of injury, with an initial (first time) spinal cord injury caused by trauma and has paralysis (muscle weakness) or loss of sensation (touch). The patient has not received medical or surgical care for this injury prior to admission to a NACTN hospital. Patient or family member must give consent to participate.
- Primary Outcome Measures
Name Time Method International Standards For Neurological Classification of Spinal Injury (ISNCSCI) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Duke University
🇺🇸Durham, North Carolina, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Hamid Shah, MD
🇺🇸Nashville, Tennessee, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Louisiana State University Medical Sciences Center in New Orleans
🇺🇸New Orleans, Louisiana, United States
University of Louisville Health Sciences Center
🇺🇸Louisville, Kentucky, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
The University of Texas, Houston
🇺🇸Houston, Texas, United States
University of Toronto/Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
University of Miami
🇺🇸Miami, Florida, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States