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| Sponsors and Collaborators: |
The Methodist Hospital System Christopher Reeve Paralysis Foundation The University of Texas Health Science Center, Houston Rehabilitation Institute of Chicago University of Virginia University of Louisville University of Toronto University of Maryland |
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| Information provided by: | The Methodist Hospital System |
| ClinicalTrials.gov Identifier: | NCT00178724 |
Purpose
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.
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury: A Consortium of Military, Veterans Administration and Civilian Hospitals |
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1
Those 18 years or older admitted to a NACTN hospital within 2 weeks of injury with a traumatic spinal cord injury and neurological deficit
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The participating centers include:
The Methodist Hospital, Houston; Northwestern University-Rehabilitation Institute of Chicago; University of Texas Health Science Center, Houston; University of Toronto, Toronto; University of Virginia, Charlottesville; University of Louisville, Louisville; University of Maryland, Baltimore
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.
Eligibility| Ages Eligible for Study: | 18 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Admitted to a NACTN hospital
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20307 | |
| Contact: Thomas Maryniak, BA 202-782-9804 thomas.maryniak@amedd.army.mil | |
| Principal Investigator: Michael Rosner, MD | |
| United States, Illinois | |
| Rehabilitation Institute of Chicago | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Deborah Pucci, PT,MS 312-238-6012 dpucci@ric.org | |
| Principal Investigator: David Chen, MD | |
| United States, Kentucky | |
| University of Louisville Health Sciences Center | Recruiting |
| Louisville, Kentucky, United States, 40205 | |
| Contact: Anne Watson, RN 502-629-5270 ajwats01@louisville.edu | |
| Principal Investigator: Christopher Shields, MD | |
| United States, Maryland | |
| University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Heather Thomas 410-328-1418 hthomas@smail.umaryland.edu | |
| Principal Investigator: Bizhan Aarabi, MD | |
| United States, Texas | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Elizabeth Toups, MS, RN 713-441-3810 etoups@tmhs.org | |
| Principal Investigator: Robert G Grossman, MD | |
| The University of Texas, Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Martha Powner, MS RN 713-500-6936 martha.Powner@uth.tmc.edu | |
| Contact: Georgene Hergenroeder, MHA RN 713-500-6130 Georgene.W.Hergenroeder@uth.tmc.edu | |
| Principal Investigator: John Crommett, MD | |
| United States, Virginia | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Contact: Elke Rost-Ruffner, RN 434-243-7336 ERL@hscmail.mcc.virginia.edu | |
| Principal Investigator: Christopher Shaffrey, MD | |
| Canada, Ontario | |
| University of Toronto/Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada, M5T-2S8 | |
| Contact: Yuliya Petrenko, MD 416-603-5285 Yuliya.Petrenko@uhn.on.ca | |
| Principal Investigator: Michael Fehlings, MD | |
| Study Chair: | Robert G Grossman, MD | The Methodist Hospital, Houston |
| Principal Investigator: | John W Crommett, 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: | David Chen, MD | Rehabilitation Institute of Chicago, Chicago |
| Principal Investigator: | Christopher Shields, 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 |
More Information
| Responsible Party: | The Methodist Hospital System ( Robert G. Grossman, MD ) |
| Study ID Numbers: | CTN1-2004(RG), CTN1-2004(RF) |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00178724 |
| Health Authority: | United States: Institutional Review Board |
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spinal cord injury SCI traumatic spinal cord injury acute spinal cord injury |
|
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
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Nervous System Diseases |
