Spinal Cord InjuryNACTNNCT00178724
Spinal Cord Injury Registry - North American Clinical Trials Network
An observational study of Spinal Cord Injury, run by Robert G. Grossman, MD at 14 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- No Treatment Given
- How many people
- 1,500 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jul 2005to Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Admitted to a NACTN hospital through the Emergency Department at the time of injury.
Who may be able to join
- 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
Who cannot join
- Any patient or family refusing consent
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Tanisha Bernhardt contact
14 sites in 2 countries
United States13 sites, 10 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Kaitlyn Henry, 410-328-0756, khenry@som.umaryland.edu
Bizhan Aarabi, MD
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Nadia Ouedraogo, 301-319-0269, nadiatou.ouedraogo.ctr@mail.mil
Christopher J Neal, MD
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22903
Judy Beenhakker, MS, 434-982-1856, JBB3P@hscmail.mcc.virginia.edu
Chun-Po Yen, MD
- Not yet recruiting
Duke University
Durham, North Carolina, 27710
Karen L Grace, BSN, 919-613-3801, karen.grace@duke.edu
Christopher I Shaffrey, MD
- Active, not recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
- Active, not recruiting
Houston Methodist Hospital
Houston, Texas, 77030
- Recruiting
The University of Texas, Houston
Houston, Texas, 77030
Lisa Schmitt, MS RN, 713-327-0116, Lisa.H.Schmitt@uth.tmc.edu
Karl Schmitt, MD
- Active, not recruiting
University of Louisville Health Sciences Center
Louisville, Kentucky, 40205
- Recruiting
University of Miami
Miami, Florida, 33136
George Jimsheleishvihi, MD, 305-243-4781, gxj150@miami.edu
James D Guest, MD, PhD
- Not yet recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cornell, BS, 414-955-0989, scornell@mcw.edu
Shekar N Kurpad, MD, PhD
- Not yet recruiting
Hamid Shah, MD
Nashville, Tennessee, 37240
Melba Isom, 615-875-5853, melba.isom@vanderbilt.edu
Hamid Shah, MD
- Recruiting
Louisiana State University Medical Sciences Center in New Orleans
New Orleans, Louisiana, 70112
Jason D Wilson, MD
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Sara Thalheimer, 215-503-9110, Sara.Thalheimer@jefferson.edu
James S Harrop, MD
Canada1 site, 1 recruiting
- Recruiting
University of Toronto/Toronto Western Hospital
Toronto, Ontario, M5T-2S8
Yuliya Petrenko, MD, 416-603-5285, Yuliya.Petrenko@uhn.on.ca
Michael G Fehlings, MD, PhD
About this study
Official title: Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- No Treatment Given
- Keywords
- spinal cord injury, SCI, traumatic spinal cord injury, acute spinal cord injury, paralysis
- Medical subject headings
- Spinal Cord Injuries, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Treatment GivenOther
Intervention is not given.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Treatment Given |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Standards For Neurological Classification of Spinal Injury (ISNCSCI)
A neurological assessment and classification of a spinal cord injury
Measured: Pre-operative, Post-operative, 2 weeks, Discharge, 3 months, 6 months, 12 months, 36 months and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionJul 2025 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert G. Grossman, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Christopher Reeve Paralysis Foundation, The Methodist Hospital Research Institute, 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
- Responsible party
- Sponsor-investigator, Robert G. Grossman, MD, The Methodist Hospital Research Institute
- Investigators
- Robert G Grossman, MD, Study chair, Houston Methodist Hospital, HoustonKarl M Schmitt, MD, Principal investigator, The University of Texas, HoustonMichael G Fehlings, MD, PhD, Principal investigator, University of Toronto/Toronto Western Hospital, TorontoEmily Sieg, MD, Principal investigator, University of Louisville, LouisvilleBizhan Aarabi, MD, Principal investigator, University of Maryland Medical Center, Baltimore Shock Trauma CenterChun-Po Yen, MD, Principal investigator, University of Virginia Health System, CharlottesvilleChristopher J Neal, MD, Principal investigator, Walter Reed National Military Medical Center, BethesdaJames S Harrop, MD, Principal investigator, Thomas Jefferson University, Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178724
- Sponsor's protocol ID
- Pro00002187
- Other IDs
- W81XWH-16-C-0031, CTN16-2020(RG)
- Acronym
- NACTN
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2005
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37607093