Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study

Last updated: June 30, 2023
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Cataplexy

Treatment

SCPP Management => 65 mmHg

Clinical Study ID

NCT03911492
H19-00805
  • Ages > 17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or Female ≥ 17 (or the provincial age of majority - depending on local REBguidelines)
  • 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 managementand CSF sample collected within 48 hours of injury
  • Initial blood sample collected within 24 hours of injury

Exclusion

Exclusion Criteria:

  • Motor incomplete spinal cord injury AIS D (i.e. at least half (half or more) of thekey muscle functions below the neurological level of injury (NLI) have a muscle gradegreater 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 intrathecalcatheter would be placed
  • Associated traumatic conditions that would interfere with the outcome assessment (e.g., traumatic brain injury, chest, pelvis, abdomen, or femur injury requiringoperative intervention)
  • Pre-existing neurodegenerative disorder, such as Parkinson's disease, Alzheimer'sdisease, Huntington's disease, multiple sclerosis, amyotrophic lateral sclerosis
  • Pre-existing thromboembolic disease or coagulopathy, such as hemophilia, vonWillebrand disease
  • Presence of systemic disease that might interfere with patient safety, compliance orevaluation 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, systemiclupus, psoriasis, or ankylosing spondylitis
  • Any other medical condition that in the investigator's opinion would render theprotocol procedures dangerous or impair the ability of the patient to receive protocoltherapy
  • Female patients who are pregnant

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: SCPP Management => 65 mmHg
Phase:
Study Start date:
August 31, 2019
Estimated Completion Date:
December 31, 2025

Study Description

Objective 1. To determine if actively maintaining an SCPP of at least 65 mmHg with a combination of MAP augmentation and CSF drainage promotes better neurologic recovery than routine hemodynamic management that focuses solely on MAP augmentation.

Objective 2. To determine if actively maintaining an SCPP of at least 65 mmHg with a combination of MAP augmentation and CSF drainage will allow for a reduction in the usage of vasopressors in acute SCI.

Objective 3. To determine the feasibility of draining CSF to reduce ITP in the acute post-injury setting, when the cord may be swollen against the dura causing subarachnoid space occlusion at the injury site.

Objective 4. To determine if there are complications associated with the installation of the intrathecal catheter and drainage of CSF in the acute SCI patient.

Connect with a study center

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Halifax Infirmary - QEII

    Halifax, Nova Scotia B3K 4N1
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec H4J1C5
    Canada

    Active - Recruiting

  • Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California 94110
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • University Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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