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North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury

This study is currently recruiting participants.
Verified May 2011 by The Methodist Hospital System
Sponsor:
Collaborators:
Christopher Reeve Paralysis Foundation
The University of Texas Health Science Center, Houston
University of Virginia
University of Louisville
University of Toronto
University of Maryland
Walter Reed Army Medical Center
Thomas Jefferson University
University of Miami
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00178724
First received: September 13, 2005
Last updated: May 17, 2011
Last verified: May 2011
History of Changes

September 13, 2005
May 17, 2011
July 2005
July 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00178724 on ClinicalTrials.gov Archive Site
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North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury
North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury: A Consortium of Military, Veterans Administration and Civilian Hospitals

The NACTN Registry is a network of clinical centers collecting standardized de-identified data from patients presenting with a new traumatic spinal cord injury(SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months following the date of injury. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation.

The participating centers include:

The Methodist Hospital, Houston; 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 Army Medical Center, Washington DC; Thomas Jefferson University,Philadelphia; University of Miami, Miami

The Biostatistics and Data Management Center is at:

The University of Texas School of Public Health, Houston.

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.
Observational
Time Perspective: Prospective
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Non-Probability Sample

Admitted to a NACTN hospital
Spinal Cord Injury
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1
Any male or female 18 years or older admitted to a NACTN hospital with an initial traumatic spinal cord injury (within 2 weeks of injury) and has neurological deficit. The patient has not received medical care for this injury prior to admission except for care at an intermediate hospital.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
July 2015
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any patient male or female > or equal to 18 years of age with an initial traumatic spinal cord injury adn neurological deficit ( motor weakness/paralysis or loss of sensation).
  • Must give informed consent

Exclusion Criteria:

  • Any patient/family refusing consent
Both
18 Years and older
No
Contact: Elizabeth Toups, MS, RN, CCRP 713-441-3897 etoups@tmhs.org
United States,   Canada
 
NCT00178724
CTN1-2004(RG), W81XWH-07-1-0361
Yes
Robert G. Grossman, MD, The Methodist Hospital System
The Methodist Hospital System
  • Christopher Reeve Paralysis Foundation
  • The University of Texas Health Science Center, Houston
  • University of Virginia
  • University of Louisville
  • University of Toronto
  • University of Maryland
  • Walter Reed Army Medical Center
  • Thomas Jefferson University
  • University of Miami
Study Chair: Robert G Grossman, MD The Methodist Hospital, Houston
Principal Investigator: Michele M Johnson, MD The University of Texas, Houston
Principal Investigator: Ralph Frankowski, PhD The University of Texas School of Public Health, Houston
Principal Investigator: Michael Fehlings, MD, PhD University of Toronto/Toronto Western Hospital, Toronto
Principal Investigator: Susan P Harkema, MD University of Louisville, Louisville, Kentucky
Principal Investigator: Bizhan Aarabi, MD University of Maryland Medical Center, Baltimore
Principal Investigator: Christopher Shaffrey, MD University of Virginia Health System, Charlottesville
Principal Investigator: Michael Rosner, MD Walter Reed Army Medical Cener
Principal Investigator: James S Harrop, MD Thomas Jefferson University
Principal Investigator: James D Guest, MD, PhD University of Miami
The Methodist Hospital System
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP