Spinal Cord Injury Registry - North American Clinical Trials Network
NCT ID: NCT00178724
Last Updated: 2020-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2005-07-31
2028-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
No Treatment Given
Intervention is not given.
Interventions
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No Treatment Given
Intervention is not given.
Eligibility Criteria
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Inclusion Criteria
* Has not received prior medical of surgical care for this injury at an intermediate hospital.
* Must give informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Christopher Reeve Paralysis Foundation
OTHER
The Methodist Hospital Research Institute
OTHER
The University of Texas Health Science Center, Houston
OTHER
University of Virginia
OTHER
University of Louisville
OTHER
University of Toronto
OTHER
University of Maryland, Baltimore
OTHER
Walter Reed National Military Medical Center
FED
Thomas Jefferson University
OTHER
University of Miami
OTHER
Brooke Army Medical Center
FED
Louisiana State University Health Sciences Center in New Orleans
OTHER
Vanderbilt University Medical Center
OTHER
Medical College of Wisconsin
OTHER
Duke University
OTHER
Robert G. Grossman, MD
OTHER
Responsible Party
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Robert G. Grossman, MD
Professor, Department of Neurosurgery
Principal Investigators
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Robert G Grossman, MD
Role: STUDY_CHAIR
Houston Methodist Hospital, Houston
Karl M Schmitt, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas, Houston
Michael G Fehlings, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto/Toronto Western Hospital, Toronto
Emily Sieg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville, Louisville
Bizhan Aarabi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland Medical Center, Baltimore Shock Trauma Center
Chun-Po Yen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Health System, Charlottesville
Christopher J Neal, MD
Role: PRINCIPAL_INVESTIGATOR
Walter Reed National Military Medical Center, Bethesda
James S Harrop, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University, Philadelphia
James D Guest, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami, Miami
Ryan P Morton, MD
Role: PRINCIPAL_INVESTIGATOR
Brooke Army Medical Center, Fort Sam Houston
Jason D Wilson, MD
Role: PRINCIPAL_INVESTIGATOR
Louisiana State University Health Sciences Center in New Orleans
Hamid Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center, Nashville
Shekar N Kurpad, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin, Milwaukee
Christopher I Shaffrey, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University, Durham
Locations
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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
The University of Texas, Houston
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University of Toronto/Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Tanisha Bernhardt
Role: CONTACT
Facility Contacts
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References
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Bak AB, Moghaddamjou A, Harrop JS, Aarabi B, Fehlings MG. The Impact of Interhospital Transfer on the Extent of Neurological Recovery in Acute Traumatic Spinal Cord Injury: Analysis of a Prospective Multicenter Data Set in 970 Cases. Neurosurgery. 2024 Jan 1;94(1):90-98. doi: 10.1227/neu.0000000000002642. Epub 2023 Aug 21.
Related Links
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NACTN's Background, Mission, Sites and Resources
Other Identifiers
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W81XWH-16-C-0031
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CTN16-2020(RG)
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00002187
Identifier Type: -
Identifier Source: org_study_id
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