The Canadian Multicentre CSF Monitoring and Biomarker Study

Completed · Not applicable

Conditions studied: Spinal Cord Injury

In brief

The purpose of this study is to: 1. Measure the pressure in the spinal fluid surrounding the spinal cord to find out how well the spinal cord is being supplied with blood. 2. Determine how drugs called "vasopressors", which are used to control blood pressure following SCI (spinal cord injury), influence spinal fluid pressure. 3. Characterize the severity of an SCI using the levels of specific proteins found within the spinal fluid. 4. Predict how much neurologic recovery may be regained using the levels of specific proteins within your spinal fluid. 5. Identify proteins within the spinal fluid that will help us learn more about what is happening after SCI and assist us in developing new treatments for SCI.

Key facts

Study ID

NCT01279811

Run by

University of British Columbia

People needed

86

Starts

2012-01-01

Expected to finish

2020-09-30

Last updated by the study team

2020-11-04

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 17 years of age or older
• Complete (AIS A)or incomplete (AIS B, C) acute SCI involving bony spinal levels between C0 and L1
• Non-penetrating injury
• Able to communicate in English and provide informed consent
• Enrolled within 48 hours after injury and able to provide CSF and blood samples within this period

You may not qualify if…

• SCI that involves sensory impairment only (i.e., no impairment in ability to move arms and legs)
• Penetrating spinal cord injury
• Isolated radiculopathy (injury only to the nerve outside of the spinal cord)
• Cauda equina injury (injury to nerve roots at the end of the spinal cord)
• Severe injury to head at the time of the SCI
• Injury to lower back (below the spinal level L1)
• Major injury to legs, arms, pelvis, chest, or abdomen that make it impossible for doctors to tell how severely injured the spinal cord is
• Have a pre-existing neurological disorder such as Parkinson's disease, Alzheimer's disease, Huntington's disease, or multiple sclerosis or amyotrophic lateral sclerosis.
• Pre-existing thromboembolic disease or coagulopathy (disorders related to blood clotting), such as haemophilia or von Willebrand's disease
• Pre-existing and ongoing infection in the body (e.g., pneumonia, urinary tract infection, cellulitis)
• Pre-existing inflammatory or autoimmune disorder such as rheumatoid arthritis, systemic lupus, psoriasis
• Systemic disease that may interfere with safety or evaluation of the condition we're studying (e.g., heart disease, HIV, HTLV-1)
• Any other medical condition that in the investigator's opinion would render the study procedures dangerous or impair ability to receive study therapy
• Pregnancy

Where it is running

• Zuckerberg San Francisco General Hospital (UCSF) — San Francisco, California, United States
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• QEII Health Sciences Centre — Halifax, Nova Scotia, Canada
• London Health Science Centre- Victoria Campus — London, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Hôpital du Sacré-Coeur — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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