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Spinal Cord Injury Registry - North American Clinical Trials Network

Recruiting
Conditions
Spinal Cord Injury
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
Inclusion Criteria
  • 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
Exclusion Criteria
  • Any patient or family refusing consent

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod

Trial Locations

Locations (14)

University of Miami

🇺🇸

Miami, Florida, United States

University of Louisville Health Sciences Center

🇺🇸

Louisville, Kentucky, United States

Louisiana State University Medical Sciences Center in New Orleans

🇺🇸

New Orleans, Louisiana, United States

University of Maryland Medical Center

🇺🇸

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

🇺🇸

Bethesda, Maryland, United States

Duke University

🇺🇸

Durham, North Carolina, United States

Thomas Jefferson University

🇺🇸

Philadelphia, Pennsylvania, United States

Hamid Shah, MD

🇺🇸

Nashville, Tennessee, United States

Brooke Army Medical Center

🇺🇸

Fort Sam Houston, Texas, United States

Houston Methodist Hospital

🇺🇸

Houston, Texas, United States

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University of Miami
🇺🇸Miami, Florida, United States
George Jimsheleishvihi, MD
Contact
305-243-4781
gxj150@miami.edu
James D Guest, MD, PhD
Principal Investigator

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