Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178724
Status:
RECRUITING
Last Update Posted:
2020-09-24
First Post:
2005-09-13
Brief Title:
Spinal Cord Injury Registry - North American Clinical Trials Network
Sponsor:
Robert G Grossman MD
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Spinal Cord Injury Registry - North American Clinical Trials Network for Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NACTN
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTN16-2020RG | OTHER | NACTN | None |
| W81XWH-16-C-0031 | OTHER_GRANT | None | None |