The Canadian Multicentre CSF Monitoring and Biomarker Study
NCT ID: NCT01279811
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2012-01-31
2020-09-30
Brief Summary
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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.
Detailed Description
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1. First, we will prospectively evaluate spinal cord perfusion pressure(SCPP)in patients with acute spinal cord injuries, to provide scientifically-based guidelines on the management of blood pressure during the acute injury phase.
2. Second, we will evaluate cerebrospinal fluid(CSF) samples from these patients with the goal of prospectively validating a series of biochemical markers that correlate with injury severity and predict neurologic outcome. Ultimately, our goals are to enhance the neurologic outcome of individuals with spinal cord injuries by improving upon their acute clinical care, and to establish biological surrogates of injury severity that may be used to facilitate clinical trials of novel therapeutic interventions for acute spinal cord injury.
Specific Aims
This multicenter study will enroll patients with acute traumatic cervical and thoracic SCI within 48 hours of their injury. A lumbar intrathecal catheter will be inserted pre-operatively for the measurement of intrathecal pressure (ITP) and the collection of CSF samples. Spinal cord perfusion pressure will be calculated as the difference between mean arterial pressure (MAP) and the ITP. The objectives of this aspect of the study will be to:
* Document the changes in SCPP over the first 5-7 days post-injury (with an intrathecal catheter that is in place for 5 days).
* Determine the effect of different vasopressor agents on SCPP.
Additionally, CSF samples will be obtained from the intrathecal catheter at 8-hour intervals to analyse the expression of the following biochemical markers: including interleukin (IL)-6, IL-8, monocyte chemo-attractant protein (MCP)-1, glial fibrillary acidic protein (GFAP), S100beta, and tau. The objectives of this aspect of the study will be to:
* Evaluate the accuracy of these inflammatory and neuronal markers at classifying the initial severity of paralysis and at predicting the extent of neurologic recovery.
* Characterize the temporal pattern of expression of these proteins to provide a more complete description of the human pathophysiology of SCI.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Single Arm
Vasopressor Crossover - Dopamine \& NORepinephrine
Crossover of vasopressors
To evaluate the effect of different vasopressor agents on SCPP, a "crossover" intervention will be conducted on patients requiring either NORepinephrine or DOPamine post-operatively, once daily for 5 days while the catheter is in place. A subject on NORepinephrine will be switched over to DOPamine for 1 hr, and then switched back to NORepinephrine. Likewise, a subject on DOPamine will be switched over to NORepinephrine for 1 hr, and then switched back to DOPamine. Subjects on both vasopressors will have DOPamine stopped for 1 hr and NORepinephrine titrated up to maintain the same MAP for 1 hr, and then brought back to the original levels of both vasopressors. On the following day, the reverse will be carried out, with a stoppage of the NORepinephrine and maintenance solely on DOPamine.
Interventions
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Crossover of vasopressors
To evaluate the effect of different vasopressor agents on SCPP, a "crossover" intervention will be conducted on patients requiring either NORepinephrine or DOPamine post-operatively, once daily for 5 days while the catheter is in place. A subject on NORepinephrine will be switched over to DOPamine for 1 hr, and then switched back to NORepinephrine. Likewise, a subject on DOPamine will be switched over to NORepinephrine for 1 hr, and then switched back to DOPamine. Subjects on both vasopressors will have DOPamine stopped for 1 hr and NORepinephrine titrated up to maintain the same MAP for 1 hr, and then brought back to the original levels of both vasopressors. On the following day, the reverse will be carried out, with a stoppage of the NORepinephrine and maintenance solely on DOPamine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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Rick Hansen Institute
OTHER
University of British Columbia
OTHER
Responsible Party
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Brian Kwon
Principal Investigator
Principal Investigators
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Brian K. Kwon, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia and Vancouver General Hospital
Locations
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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
Countries
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References
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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.
Rosner J, Negraeff M, Belanger LM, Tsang A, Ritchie L, Mac-Thiong JM, Christie S, Wilson JR, Dhall S, Charest-Morin R, Street J, Ailon T, Paquette S, Dea N, Fisher CG, Dvorak MF, Finnerup NB, Kwon BK, Kramer JLK. Characterization of Hyperacute Neuropathic Pain after Spinal Cord Injury: A Prospective Study. J Pain. 2022 Jan;23(1):89-97. doi: 10.1016/j.jpain.2021.06.013. Epub 2021 Jul 21.
Other Identifiers
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H10-01091
Identifier Type: -
Identifier Source: org_study_id