Clinical trial NCT00178724: Spinal Cord Injury Registry - North American Clinical Trials Network
Official title: Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
SCI
traumatic spinal cord injury
acute spinal cord injury
paralysis
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Christopher Reeve Paralysis Foundation
name: The Methodist Hospital Research Institute
name: The University of Texas Health Science Center, Houston
name: University of Virginia
name: University of Louisville
name: University of Toronto
name: University of Maryland, Baltimore
name: Walter Reed National Military Medical Center
name: Thomas Jefferson University
name: University of Miami
name: Brooke Army Medical Center
name: Louisiana State University Health Sciences Center in New Orleans
name: Vanderbilt University Medical Center
name: Medical College of Wisconsin
name: Duke University
First posted: 2005-09-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted to a NACTN hospital through the Emergency Department at the time of injury.

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.

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.

Eligibility 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

Primary outcomes:
measure: International Standards For Neurological Classification of Spinal Injury (ISNCSCI)
timeFrame: Pre-operative, Post-operative, 2 weeks, Discharge, 3 months, 6 months, 12 months, 36 months and 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Louisville
country: United States
facility: University of Louisville Health Sciences Center
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University Medical Sciences Center in New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Hamid Shah, MD
state: Tennessee
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas, Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: University of Toronto/Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Houston Methodist Hospital, Houston
name: Robert G Grossman, MD
role: STUDY_CHAIR
affiliation: The University of Texas, Houston
name: Karl M Schmitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto/Toronto Western Hospital, Toronto
name: Michael G Fehlings, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville, Louisville
name: Emily Sieg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland Medical Center, Baltimore Shock Trauma Center
name: Bizhan Aarabi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia Health System, Charlottesville
name: Chun-Po Yen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed National Military Medical Center, Bethesda
name: Christopher J Neal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University, Philadelphia
name: James S Harrop, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami, Miami
name: James D Guest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brooke Army Medical Center, Fort Sam Houston
name: Ryan P Morton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Jason D Wilson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center, Nashville
name: Hamid Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin, Milwaukee
name: Shekar N Kurpad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University, Durham
name: Christopher I Shaffrey, MD
role: PRINCIPAL_INVESTIGATOR
References: