Spinal Cord Injury Registry - North American Clinical Trials Network

NCT ID: NCT00178724

Last Updated: 2020-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2028-07-31

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injury

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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No Treatment Given

Any male or female 18 years or older admitted to a NACTN hospital, at the time of injury, with an initial (first time) spinal cord injury caused by trauma and has paralysis (muscle weakness) or loss of sensation (touch). The patient has not received medical or surgical care for this injury prior to admission to a NACTN hospital. Patient or family member must give consent to participate.

No Treatment Given

Intervention Type OTHER

Intervention is not given.

Interventions

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No Treatment Given

Intervention is not given.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christopher Reeve Paralysis Foundation

OTHER

Sponsor Role collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

Brooke Army Medical Center

FED

Sponsor Role collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Robert G. Grossman, MD

OTHER

Sponsor Role lead

Responsible Party

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Robert G. Grossman, MD

Professor, Department of Neurosurgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert G Grossman, MD

Role: STUDY_CHAIR

Houston Methodist Hospital, Houston

Karl M Schmitt, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas, Houston

Michael G Fehlings, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto/Toronto Western Hospital, Toronto

Emily Sieg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville, Louisville

Bizhan Aarabi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Medical Center, Baltimore Shock Trauma Center

Chun-Po Yen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System, Charlottesville

Christopher J Neal, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center, Bethesda

James S Harrop, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University, Philadelphia

James D Guest, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami, Miami

Ryan P Morton, MD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center, Fort Sam Houston

Jason D Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center in New Orleans

Hamid Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center, Nashville

Shekar N Kurpad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin, Milwaukee

Christopher I Shaffrey, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University, Durham

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

University of Louisville Health Sciences Center

Louisville, Kentucky, United States

Site Status ACTIVE_NOT_RECRUITING

Louisiana State University Medical Sciences Center in New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status RECRUITING

Duke University

Durham, North Carolina, United States

Site Status NOT_YET_RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Hamid Shah, MD

Nashville, Tennessee, United States

Site Status NOT_YET_RECRUITING

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Houston Methodist Hospital

Houston, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

The University of Texas, Houston

Houston, Texas, United States

Site Status RECRUITING

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status NOT_YET_RECRUITING

University of Toronto/Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Elizabeth G Toups, MSN, RN, CCRP

Role: CONTACT

832-722-4055

Tanisha Bernhardt

Role: CONTACT

713-441-3814

Facility Contacts

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George Jimsheleishvihi, MD

Role: primary

305-243-4781

Kaitlyn Henry

Role: primary

410-328-0756

Nadia Ouedraogo

Role: primary

301-319-0269

Karen L Grace, BSN

Role: primary

919-613-3801

Sara Thalheimer

Role: primary

215-503-9110

Melba Isom

Role: primary

615-875-5853

Lisa Schmitt, MS RN

Role: primary

713-327-0116

Judy Beenhakker, MS

Role: primary

434-982-1856

Sarah Cornell, BS

Role: primary

414-955-0989

Yuliya Petrenko, MD

Role: primary

416-603-5285

References

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Bak AB, Moghaddamjou A, Harrop JS, Aarabi B, Fehlings MG. The Impact of Interhospital Transfer on the Extent of Neurological Recovery in Acute Traumatic Spinal Cord Injury: Analysis of a Prospective Multicenter Data Set in 970 Cases. Neurosurgery. 2024 Jan 1;94(1):90-98. doi: 10.1227/neu.0000000000002642. Epub 2023 Aug 21.

Reference Type DERIVED
PMID: 37607093 (View on PubMed)

Related Links

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https://www.christopherreeve.org/research/nactn/about-nactn

NACTN's Background, Mission, Sites and Resources

Other Identifiers

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W81XWH-16-C-0031

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CTN16-2020(RG)

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00002187

Identifier Type: -

Identifier Source: org_study_id

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