NCT00135278

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
2.5 years until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2009

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2010

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

August 23, 2005

Last Update Submit

October 24, 2017

Conditions

Keywords

NeuroprotectioninflammationcytokinesCSF

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

OTHER
Procedure: CSF Drainage

No CSF Drainage

OTHER
Procedure: No CSF Drainage

Interventions

CSF DrainagePROCEDURE

See Detailed Description

CSF Drainage

See Detailed Description

No CSF Drainage

Eligibility Criteria

Age17 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Spinal Cord InjuriesInflammation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dr. Brian Kwon, MD, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

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

Locations