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Cerebrospinal Fluid (CSF) Drainage and Cytokine Profiling in the Treatment of Acute Spinal Cord Injury (SCI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135278
First Posted: August 25, 2005
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Kwon, University of British Columbia
  Purpose
The overall purpose of this pilot study is to evaluate CSF drainage as a potential neuroprotective strategy after acute spinal cord injury (SCI).

Condition Intervention
Spinal Cord Injuries Procedure: CSF Drainage Procedure: No CSF Drainage

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cerebrospinal Fluid (CSF) Drainage and Cytokine Profiling in the Treatment of Acute Spinal Cord Injury (SCI) - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Brian Kwon, University of British Columbia:

Primary Outcome Measures:
  • To evaluate the safety and feasibility of CSF drainage as a potential treatment for patients with acute SCI

Secondary Outcome Measures:
  • 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

Enrollment: 31
Study Start Date: March 2008
Study Completion Date: January 14, 2010
Primary Completion Date: January 27, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CSF Drainage Procedure: CSF Drainage
See Detailed Description
No CSF Drainage Procedure: No CSF Drainage
See Detailed Description

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pre-existing neurodegenerative disorder
  • Associated head or spine injury
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135278


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Dr. Brian Kwon, MD, PhD University of British Columbia
  More Information

Responsible Party: Brian Kwon, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT00135278     History of Changes
Other Study ID Numbers: C04-0584
V05-0160
First Submitted: August 23, 2005
First Posted: August 25, 2005
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Brian Kwon, University of British Columbia:
Neuroprotection
inflammation
cytokines
CSF

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System