Spinal Cord Injury Registry - North American Clinical Trials Network

Study Overview
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Brief Summary
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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
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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.

Official Title
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Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Other: No Treatment Given


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment Given<br>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. | Other: No Treatment Given<br>* Intervention is not given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Standards For Neurological Classification of Spinal Injury (ISNCSCI) | A neurological assessment and classification of a spinal cord injury | Pre-operative, Post-operative, 2 weeks, Discharge, 3 months, 6 months, 12 months, 36 months and 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, SCI, traumatic spinal cord injury, acute spinal cord injury, paralysis