RECRUITING

Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study

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Conditions

Acute Spinal Cord InjuryAcute Spinal ParalysisSpinal Cord InjuriesSPINAL FractureSCISpinal Cord InjuryCSFBiomarkerCSF pressureTraumatic SCIPerfusion pressure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This multicenter study will enroll 100 patients with acute traumatic cervical and thoracic SCI who have a lumbar intrathecal catheter inserted within 24 hours of their injury. The lumbar intrathecal catheter will be inserted pre-operatively for the measurement of ITP and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between MAP and the ITP. There are two important distinct yet related objectives in this prospective interventional study. 1. Determine the effect of SCPP maintenance ≥ 65 mmHg in acute SCI on neurologic recovery as measured by ASIA Impairment Scale (AIS) grade conversion and motor score improvement. 2. Collect CSF and blood samples for the measurement of neurochemical biomarkers and storage for future biomarker discovery and validation studies.

Official Title

Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study

Quick Facts

Study Start:2019-08-31
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03911492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female ≥ 17 (or the provincial age of majority - depending on local REB guidelines)
  2. * Complete (AIS A) or incomplete (AIS B, C) acute traumatic spinal cord injury.
  3. * Bony spinal levels between C0 and T12 inclusive.
  4. * Blunt (non-penetrating) spinal cord injury treated either surgically or non-surgically
  5. * Lumbar intrathecal catheter to be inserted as part of clinical hemodynamic management and CSF sample collected within 48 hours of injury
  6. * Initial blood sample collected within 24 hours of injury
  1. * 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)
  2. * Spinal cord injury with sensory deficit only (i.e. no motor deficit)
  3. * Penetrating spinal cord injury (including gunshot wounds)
  4. * Isolated radiculopathy
  5. * Isolated cauda equina injury or spinal injury below L1
  6. * Associated injury (soft tissue or bony) to the lumbar spine where the intrathecal catheter would be placed
  7. * Associated traumatic conditions that would interfere with the outcome assessment (e.g., traumatic brain injury, chest, pelvis, abdomen, or femur injury requiring operative intervention)
  8. * Pre-existing neurodegenerative disorder, such as Parkinson's disease, Alzheimer's disease, Huntington's disease, multiple sclerosis, amyotrophic lateral sclerosis
  9. * Pre-existing thromboembolic disease or coagulopathy, such as hemophilia, von Willebrand disease
  10. * 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
  11. * Pre-existing inflammatory or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus, psoriasis, or ankylosing spondylitis
  12. * 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
  13. * Female patients who are pregnant

Contacts and Locations

Study Contact

Allan Aludino
CONTACT
604-875-4111
allan.aludino@vch.ca

Principal Investigator

Brian Kwon, MD, PhD
PRINCIPAL_INVESTIGATOR
University of British Columbia, Faculty of Medicine

Study Locations (Sites)

Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
United States
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of British Columbia

  • Brian Kwon, MD, PhD, PRINCIPAL_INVESTIGATOR, University of British Columbia, Faculty of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-31
Study Completion Date2025-12

Study Record Updates

Study Start Date2019-08-31
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • SCI
  • Spinal Cord Injury
  • CSF
  • Biomarker
  • CSF pressure
  • Traumatic SCI
  • Perfusion pressure

Additional Relevant MeSH Terms

  • Acute Spinal Cord Injury
  • Acute Spinal Paralysis
  • Spinal Cord Injuries
  • SPINAL Fracture