Spinal Cord Injury Registry - North American Clinical Trials Network

Spinal Cord Injury Clinical Trial

— NACTN  

Official title:

Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00178724
• Other study ID #: Pro00002187
• Secondary ID: W81XWH-16-C-0031
• Status: Recruiting
• Start date: July 2005
• Est. completion date: July 2028

Study information

• Verified date: September 2020
• Source: The Methodist Hospital System
• Contact: Elizabeth G Toups, MSN, RN, CCRP
• Phone: 832-722-4055
• Email: etoups[@]houstonmethodist.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: July 2028
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Other:
• No Treatment Given
Intervention is not given.

Locations

Country	Name	City	State
Canada	University of Toronto/Toronto Western Hospital	Toronto	Ontario
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Duke University	Durham	North Carolina
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	The University of Texas, Houston	Houston	Texas
United States	University of Louisville Health Sciences Center	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hamid Shah, MD	Nashville	Tennessee
United States	Louisiana State University Medical Sciences Center in New Orleans	New Orleans	Louisiana
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (16)

Lead Sponsor

Collaborator

Robert G. Grossman, MD

Brooke Army Medical Center, Christopher Reeve Paralysis Foundation, Duke University, Louisiana State University Health Sciences Center in New Orleans, Medical College of Wisconsin, The Methodist Hospital System, The University of Texas Health Science Center, Houston, Thomas Jefferson University, University of Louisville, University of Maryland, Baltimore, University of Miami, University of Toronto, University of Virginia, Vanderbilt University Medical Center, Walter Reed National Military Medical Center

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   NACTN's Background, Mission, Sites and Resources