North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury
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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: | Time Perspective: 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: | 500 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Admitted to a NACTN hospital
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
Contacts and Locations| Contact: Elizabeth Toups, MS, RN, CCRP | 713-441-3897 | etoups@tmhs.org |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20307 | |
| Contact: Vicki Miskovsky 202-782-4780 vicki.miskovsky@us.army.mil | |
| Principal Investigator: Michael Rosner, MD | |
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Marina Dididze, M.D., PhD 305-243-4781 MDididze@med.miami.edu | |
| Principal Investigator: James D Guest, M.D., PhD | |
| United States, Kentucky | |
| University of Louisville Health Sciences Center | Recruiting |
| Louisville, Kentucky, United States, 40205 | |
| Contact: Elizabeth A McDowell, RN, BSN, CCRC 502-581-8675 eamcdo01@louisville.edu | |
| Principal Investigator: Susan Harkema, PhD | |
| United States, Maryland | |
| University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Charlene Aldrich, RN, MSN 410-328-5332 caldrich@smail.umaryland.edu | |
| Principal Investigator: Bizhan Aarabi, MD | |
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Amanda Salvatore 215-503-5739 Amanda.salvatore@jefferson.edu | |
| Principal Investigator: James S Harrop, MD | |
| United States, Texas | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Elizabeth Toups, MSN, CCRP 713-441-3897 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 | |
| Principal Investigator: Michele M Johnson, MD | |
| United States, Virginia | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Contact: Daniel Chernavsky, MD, PhD 434-243-9986 Drc2v@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, PhD | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Robert G. Grossman, MD, The Methodist Hospital System |
| ClinicalTrials.gov Identifier: | NCT00178724 History of Changes |
| Other Study ID Numbers: | CTN1-2004(RG), W81XWH-07-1-0361 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Methodist Hospital System:
|
spinal cord injury SCI traumatic spinal cord injury acute spinal cord injury |
Additional relevant MeSH terms:
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Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013