Study on spinal cord pressure and biomarkers in acute injuries
Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
This study is testing if keeping spinal cord pressure at a certain level helps people with recent spinal cord injuries recover better and if draining fluid can help with pressure in the brain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 17 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT03911492 on ClinicalTrials.gov |
What this trial studies
This multicenter study aims to enroll 100 patients with acute traumatic cervical and thoracic spinal cord injuries who will have a lumbar intrathecal catheter inserted within 24 hours of their injury. The study will measure spinal cord perfusion pressure (SCPP) and collect cerebrospinal fluid (CSF) samples to evaluate the impact of maintaining an SCPP of at least 65 mmHg on neurological recovery. Additionally, it will assess the feasibility of CSF drainage to reduce intracranial pressure and the potential complications associated with catheter installation. The study will also explore the relationship between SCPP management and the need for vasopressors in acute spinal cord injury cases.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 17 or older with complete or incomplete acute traumatic spinal cord injuries between the cervical and thoracic regions.
Not a fit: Patients with motor incomplete spinal cord injuries or those with sensory deficits only may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved neurological recovery for patients with acute spinal cord injuries.
How similar studies have performed: Other studies have shown promise in managing spinal cord perfusion pressure, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or Female ≥ 17 (or the provincial age of majority - depending on local REB guidelines) * Complete (AIS A) or incomplete (AIS B, C) acute traumatic spinal cord injury. * Bony spinal levels between C0 and T12 inclusive. * Blunt (non-penetrating) spinal cord injury treated either surgically or non-surgically * Lumbar intrathecal catheter to be inserted as part of clinical hemodynamic management and CSF sample collected within 48 hours of injury * Initial blood sample collected within 24 hours of injury Exclusion Criteria: * Motor incomplete spinal cord injury AIS D (i.e. at least half (half or more) of the key muscle functions below the neurological level of injury (NLI) have a muscle grade greater than or equal to 3/5) * Spinal cord injury with sensory deficit only (i.e. no motor deficit) * Penetrating spinal cord injury (including gunshot wounds) * Isolated radiculopathy * Isolated cauda equina injury or spinal injury below L1 * Associated injury (soft tissue or bony) to the lumbar spine where the intrathecal catheter would be placed * Associated traumatic conditions that would interfere with the outcome assessment (e.g., traumatic brain injury, chest, pelvis, abdomen, or femur injury requiring operative intervention) * Pre-existing neurodegenerative disorder, such as Parkinson's disease, Alzheimer's disease, Huntington's disease, multiple sclerosis, amyotrophic lateral sclerosis * Pre-existing thromboembolic disease or coagulopathy, such as hemophilia, von Willebrand disease * Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g., clinically significant cardiac disease, HIV, Hep B or C) HTLV-1 * Pre-existing inflammatory or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus, psoriasis, or ankylosing spondylitis * Any other medical condition that in the investigator's opinion would render the protocol procedures dangerous or impair the ability of the patient to receive protocol therapy * Female patients who are pregnant
Where this trial is running
San Francisco, California and 7 other locations
- Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (Recruiting)
- University Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
- Halifax Infirmary - QEII — Halifax, Nova Scotia, Canada (Recruiting)
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Hopital Du Sacre-Coeur de Montreal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Brian Kwon, MD, PhD — University of British Columbia, Faculty of Medicine
- Study coordinator: Allan Aludino
- Email: allan.aludino@vch.ca
- Phone: 604-875-4111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.