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Spinal Cord Injury Registry - North American Clinical Trials Network (NACTN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00178724
Recruitment Status : Recruiting
First Posted : September 15, 2005
Last Update Posted : September 24, 2020
Sponsor:
Collaborators:
Christopher Reeve Paralysis Foundation
The Methodist Hospital System
The University of Texas Health Science Center, Houston
University of Virginia
University of Louisville
University of Toronto
University of Maryland, Baltimore
Walter Reed National Military Medical Center
Thomas Jefferson University
University of Miami
Brooke Army Medical Center
Louisiana State University Health Sciences Center in New Orleans
Vanderbilt University Medical Center
Medical College of Wisconsin
Duke University
Information provided by (Responsible Party):
Robert G. Grossman, MD, The Methodist Hospital System

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 15, 2005
Last Update Posted Date September 24, 2020
Study Start Date July 2005
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 6, 2015)
International Standards For Neurological Classification of Spinal Injury (ISNCSCI) [ Time Frame: 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
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Spinal Cord Injury Registry - North American Clinical Trials Network
Official Title Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Admitted to a NACTN hospital through the Emergency Department at the time of injury.
Condition Spinal Cord Injury
Intervention Other: No Treatment Given
Intervention is not given.
Study Groups/Cohorts 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.
Intervention: Other: No Treatment Given
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 6, 2015)
1500
Original Enrollment
 (submitted: September 13, 2005)
100
Estimated Study Completion Date July 2028
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Elizabeth G Toups, MSN, RN, CCRP 832-722-4055 etoups@houstonmethodist.org
Contact: Tanisha Bernhardt 713-441-3814
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00178724
Other Study ID Numbers Pro00002187
W81XWH-16-C-0031 ( Other Grant/Funding Number: Department of Defense )
CTN16-2020(RG) ( Other Identifier: NACTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Robert G. Grossman, MD, The Methodist Hospital System
Study Sponsor Robert G. Grossman, MD
Collaborators
  • Christopher Reeve Paralysis Foundation
  • The Methodist Hospital System
  • The University of Texas Health Science Center, Houston
  • University of Virginia
  • University of Louisville
  • University of Toronto
  • University of Maryland, Baltimore
  • Walter Reed National Military Medical Center
  • Thomas Jefferson University
  • University of Miami
  • Brooke Army Medical Center
  • Louisiana State University Health Sciences Center in New Orleans
  • Vanderbilt University Medical Center
  • Medical College of Wisconsin
  • Duke University
Investigators
Study Chair: Robert G Grossman, MD Houston Methodist Hospital, Houston
Principal Investigator: Karl M Schmitt, MD The University of Texas, Houston
Principal Investigator: Michael G Fehlings, MD, PhD University of Toronto/Toronto Western Hospital, Toronto
Principal Investigator: Emily Sieg, MD University of Louisville, Louisville
Principal Investigator: Bizhan Aarabi, MD University of Maryland Medical Center, Baltimore Shock Trauma Center
Principal Investigator: Chun-Po Yen, MD University of Virginia Health System, Charlottesville
Principal Investigator: Christopher J Neal, MD Walter Reed National Military Medical Center, Bethesda
Principal Investigator: James S Harrop, MD Thomas Jefferson University, Philadelphia
Principal Investigator: James D Guest, MD, PhD University of Miami, Miami
Principal Investigator: Ryan P Morton, MD Brooke Army Medical Center, Fort Sam Houston
Principal Investigator: Jason D Wilson, MD Louisiana State University Health Sciences Center in New Orleans
Principal Investigator: Hamid Shah, MD Vanderbilt University Medical Center, Nashville
Principal Investigator: Shekar N Kurpad, MD, PhD Medical College of Wisconsin, Milwaukee
Principal Investigator: Christopher I Shaffrey, MD Duke University, Durham
PRS Account The Methodist Hospital System
Verification Date September 2020