Recruiting

Observational Study

Sponsor:

Robert G. Grossman, MD

Code:

NCT00178724

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No Treatment Given

Study Details

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.

Conditions

Spinal Cord Injury

Study ID

NCT00178724

Start date

Jul, 2005

Status verified date

Sep, 2020

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

No Treatment Given

Intervention is not given.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Elizabeth G Toups, MSN, RN, CCRP

832-722-4055etoups@houstonmethodist.org

Tanisha Bernhardt

713-441-3814

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

George Jimsheleishvihi, MD

305-243-4781gxj150@miami.edu

Principal Investigator:

James D Guest, MD, PhD

Louisiana State University Medical Sciences Center in New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Principal Investigator:

Jason D Wilson, MD

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kaitlyn Henry

410-328-0756khenry@som.umaryland.edu

Principal Investigator:

Bizhan Aarabi, MD

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Nadia Ouedraogo

301-319-0269nadiatou.ouedraogo.ctr@mail.mil

Principal Investigator:

Christopher J Neal, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Sara Thalheimer

215-503-9110Sara.Thalheimer@jefferson.edu

Principal Investigator:

James S Harrop, MD

The University of Texas, Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Lisa Schmitt, MS RN

713-327-0116Lisa.H.Schmitt@uth.tmc.edu

Principal Investigator:

Karl Schmitt, MD

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Judy Beenhakker, MS

434-982-1856JBB3P@hscmail.mcc.virginia.edu

Principal Investigator:

Chun-Po Yen, MD

University of Toronto/Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T-2S8

Contacts

Yuliya Petrenko, MD

416-603-5285Yuliya.Petrenko@uhn.on.ca

Principal Investigator:

Michael G Fehlings, MD, PhD

More Information

Sponsor

Robert G. Grossman, MD

Last update posted

Sep 24, 2020

Last verified

Sep, 2020

Keywords

  • spinal cord injury
  • SCI
  • traumatic spinal cord injury
  • acute spinal cord injury
  • paralysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Robert G. Grossman, MD on 2020-09-24.