NCT00178724

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jul 2005

Longer than P75 for all trials

Geographic Reach
2 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jul 2005Jul 2028

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
19.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Expected
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

20 years

First QC Date

September 13, 2005

Last Update Submit

September 22, 2020

Conditions

Spinal Cord Injury

Keywords

spinal cord injurySCItraumatic spinal cord injuryacute spinal cord injuryparalysis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: No Treatment Given

Interventions

No Treatment GivenOTHER

Intervention is not given.

No Treatment Given

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Admitted to a NACTN hospital through the Emergency Department at the time of injury.

You may qualify if:

  • 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

You may not qualify if:

  • Any patient or family refusing consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

University of Louisville Health Sciences Center

Louisville, Kentucky, 40205, United States

ACTIVE NOT RECRUITING

Louisiana State University Medical Sciences Center in New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Hamid Shah, MD

Nashville, Tennessee, 37240, United States

NOT YET RECRUITING

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

ACTIVE NOT RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

The University of Texas, Houston

Houston, Texas, 77030, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

University of Toronto/Toronto Western Hospital

Toronto, Ontario, M5T-2S8, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37607093DERIVED

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesParalysis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert G Grossman, MD

    Houston Methodist Hospital, Houston

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth G Toups, MSN, RN, CCRP

CONTACT

832-722-4055etoups@houstonmethodist.org

Tanisha Bernhardt

CONTACT

713-441-3814

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Neurosurgery

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

July 1, 2005

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2028

Last Updated

September 24, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(13)CA(1)