Cerebrospinal Fluid (CSF) Drainage and Cytokine Profiling in the Treatment of Acute Spinal Cord Injury (SCI)
2 other identifiers
interventional
31
1 country
1
Brief Summary
The overall purpose of this pilot study is to evaluate CSF drainage as a potential neuroprotective strategy after acute spinal cord injury (SCI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2005
CompletedFirst Posted
Study publicly available on registry
August 25, 2005
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2010
CompletedOctober 26, 2017
October 1, 2017
11 months
August 23, 2005
October 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and feasibility of CSF drainage as a potential treatment for patients with acute SCI
Secondary Outcomes (2)
To determine if CSF drainage will improve neurologic function after acute SCI
To evaluate the temporal pattern of expression of inflammatory cytokines within the CSF
Study Arms (2)
CSF Drainage
OTHERNo CSF Drainage
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Injured subjects:
- Complete or incomplete acute SCI between C0 and T11
- Admitted within 48 hours of injury
- Undergoing spinal decompressive surgery
- Undergoing lumbar puncture for spinal anesthetic or myelography
- Neurologically intact
You may not qualify if:
- Pre-existing neurodegenerative disorder
- Associated head or spine injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Related Publications (1)
Stukas S, Cooper J, Gill J, Fallah N, Skinnider MA, Belanger L, Ritchie L, Tsang A, Dong K, Streijger F, Street J, Paquette S, Ailon T, Dea N, Charest-Morin R, Fisher CG, Bailey CS, Dhall S, Mac-Thiong JM, Wilson JR, Christie S, Dvorak MF, Wellington CL, Kwon BK. Association of CSF and Serum Neurofilament Light and Glial Fibrillary Acidic Protein, Injury Severity, and Outcome in Spinal Cord Injury. Neurology. 2023 Mar 21;100(12):e1221-e1233. doi: 10.1212/WNL.0000000000206744. Epub 2023 Jan 4.
PMID: 36599698DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Brian Kwon, MD, PhD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 23, 2005
First Posted
August 25, 2005
Study Start
March 1, 2008
Primary Completion
January 27, 2009
Study Completion
January 14, 2010
Last Updated
October 26, 2017
Record last verified: 2017-10