Recruiting

Biomarker Study

Sponsor:

University of British Columbia

Code:

NCT03911492

Conditions

Acute Spinal Cord Injury

Acute Spinal Paralysis

Spinal Cord Injuries

SPINAL Fracture

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Interventions

SCPP Management => 65 mmHg

Study Details

Brief 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.

Conditions

Acute Spinal Cord Injury

Acute Spinal Paralysis

Spinal Cord Injuries

SPINAL Fracture

Study ID

NCT03911492

Start date

Aug 31, 2019

Status verified date

Jun, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: SCP Pressure Management

Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg.

Interventions

SCPP Management => 65 mmHg

A lumbar intrathecal catheter will be inserted pre-operatively for the measurement of Intrathecal pressure (ITP) and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between Mean Arterial Pressure (MAP) and the ITP.

Primary outcome measure

  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Allan Aludino

604-875-4111allan.aludino@vch.ca

Locations

Zuckerberg San Francisco General Hospital and Trauma Center

Recruiting

San Francisco, California, United States, 94110

Principal Investigator:

Anthony DiGiorgio, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Principal Investigator:

Jamie Wilson, MD

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Principal Investigator:

Christian Ricks, MD

University Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

David Okonkwo

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Allan Aludino, Research Program Manager

1-604-875-4111Allan.Aludino@vch.ca

Principal Investigator:

Brian Kwon, MD, PhD

Halifax Infirmary - QEII

Recruiting

Halifax, Nova Scotia, Canada, B3K 4N1

Principal Investigator:

Sean Christie, MD

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Principal Investigator:

Jeff Wilson, MD

Hopital Du Sacre-Coeur de Montreal

Recruiting

Montreal, Quebec, Canada, H4J1C5

Principal Investigator:

Jean-Marc Mac-Thiong, MD

More Information

Sponsor

University of British Columbia

Last update posted

Jul 3, 2023

Last verified

Jun, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-07-03.