Spinal Cord Injury Registry - North American Clinical Trials Network (NACTN)
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| ClinicalTrials.gov Identifier: NCT00178724 |
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Recruitment Status :
Recruiting
First Posted : September 15, 2005
Last Update Posted : September 24, 2020
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Sponsor:
Robert G. Grossman, MD
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
Information provided by (Responsible Party):
Robert G. Grossman, MD, The Methodist Hospital Research Institute
- Study Details
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Spinal Cord Injury | Other: No Treatment Given |
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 |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury |
| Study Start Date : | July 2005 |
| Estimated Primary Completion Date : | July 2025 |
| Estimated Study Completion Date : | July 2028 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Spinal Cord Injuries
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: No Treatment Given
Intervention is not given. |
Primary Outcome Measures :
- 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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Admitted to a NACTN hospital through the Emergency Department at the time of injury.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178724
Contacts
| Contact: Elizabeth G Toups, MSN, RN, CCRP | 832-722-4055 | etoups@houstonmethodist.org | |
| Contact: Tanisha Bernhardt | 713-441-3814 |
Locations
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: George Jimsheleishvihi, MD 305-243-4781 gxj150@miami.edu | |
| Principal Investigator: James D Guest, MD, PhD | |
| United States, Kentucky | |
| University of Louisville Health Sciences Center | Active, not recruiting |
| Louisville, Kentucky, United States, 40205 | |
| United States, Louisiana | |
| Louisiana State University Medical Sciences Center in New Orleans | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Principal Investigator: Jason D Wilson, MD | |
| United States, Maryland | |
| University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Kaitlyn Henry 410-328-0756 khenry@som.umaryland.edu | |
| Principal Investigator: Bizhan Aarabi, MD | |
| Walter Reed National Military Medical Center | Recruiting |
| Bethesda, Maryland, United States, 20889 | |
| Contact: Nadia Ouedraogo 301-319-0269 nadiatou.ouedraogo.ctr@mail.mil | |
| Principal Investigator: Christopher J Neal, MD | |
| United States, North Carolina | |
| Duke University | Not yet recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Karen L Grace, BSN 919-613-3801 karen.grace@duke.edu | |
| Principal Investigator: Christopher I Shaffrey, MD | |
| Sub-Investigator: Muhammad Abd-El-Barr, MD, PhD | |
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Sara Thalheimer 215-503-9110 Sara.Thalheimer@jefferson.edu | |
| Principal Investigator: James S Harrop, MD | |
| United States, Tennessee | |
| Hamid Shah, MD | Not yet recruiting |
| Nashville, Tennessee, United States, 37240 | |
| Contact: Melba Isom 615-875-5853 melba.isom@vanderbilt.edu | |
| Principal Investigator: Hamid Shah, MD | |
| United States, Texas | |
| Brooke Army Medical Center | Active, not recruiting |
| Fort Sam Houston, Texas, United States, 78234 | |
| Houston Methodist Hospital | Active, not recruiting |
| Houston, Texas, United States, 77030 | |
| The University of Texas, Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Lisa Schmitt, MS RN 713-327-0116 Lisa.H.Schmitt@uth.tmc.edu | |
| Principal Investigator: Karl Schmitt, MD | |
| United States, Virginia | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Contact: Judy Beenhakker, MS 434-982-1856 JBB3P@hscmail.mcc.virginia.edu | |
| Principal Investigator: Chun-Po Yen, MD | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Sarah Cornell, BS 414-955-0989 scornell@mcw.edu | |
| Principal Investigator: Shekar N Kurpad, MD, PhD | |
| Canada, Ontario | |
| University of Toronto/Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada, M5T-2S8 | |
| Contact: Yuliya Petrenko, MD 416-603-5285 Yuliya.Petrenko@uhn.on.ca | |
| Principal Investigator: Michael G Fehlings, MD, PhD | |
Sponsors and Collaborators
Robert G. Grossman, MD
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
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 |
| Responsible Party: | Robert G. Grossman, MD, Professor, Department of Neurosurgery, The Methodist Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00178724 |
| Other Study ID Numbers: |
Pro00002187 W81XWH-16-C-0031 ( Other Grant/Funding Number: Department of Defense ) CTN16-2020(RG) ( Other Identifier: NACTN ) |
| First Posted: | September 15, 2005 Key Record Dates |
| Last Update Posted: | September 24, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Robert G. Grossman, MD, The Methodist Hospital Research Institute:
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spinal cord injury SCI traumatic spinal cord injury acute spinal cord injury paralysis |
Additional relevant MeSH terms:
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Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |