Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT03911492
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT03911492
Study Brief:
Protocol Section:
NCT03911492