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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00135278
First received: August 23, 2005
Last updated: April 8, 2011
Last verified: April 2011
  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 will be drained using an epidural catheter inserted via lumbar puncture for 72 hours.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 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 [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if CSF drainage will improve neurologic function after acute SCI [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • To evaluate the temporal pattern of expression of inflammatory cytokines within the CSF [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: CSF will be drained using an epidural catheter inserted via lumbar puncture for 72 hours.
    See Detailed Description
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135278

Contacts
Contact: Allan Aludino (604) 875-4111 ext 62837

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Alan Aludino    (604) 875-4111 ext 62837      
Principal Investigator: Dr. Brian Kwon, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Dr. Brian Kwon, MD, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Brian Kwon, University of British Columbia
ClinicalTrials.gov Identifier: NCT00135278     History of Changes
Other Study ID Numbers: C04-0584, V05-0160
Study First Received: August 23, 2005
Last Updated: April 8, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 19, 2014