Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study

Launched by UNIVERSITY OF BRITISH COLUMBIA · Apr 9, 2019

Keywords

ClinConnect Summary

The Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study is looking at how maintaining a specific level of spinal cord blood flow can help people recover from acute spinal cord injuries. The study will enroll 100 participants who have experienced a recent injury to their neck or upper back. If eligible, participants will have a special catheter placed in their lower back to measure spinal fluid pressure and collect samples for research. The main goals are to see if keeping spinal cord blood flow at a certain level helps improve movement and function, and to gather samples that could help identify new markers for spinal cord injury recovery in the future.

To be eligible for the study, participants must be at least 17 years old and have suffered a complete or incomplete spinal cord injury due to a blunt force. They should also have their catheter placed within 48 hours of the injury and have an initial blood sample taken within 24 hours. Participants will undergo assessments to track their recovery, and their health will be monitored throughout the study. This research is important because it aims to improve understanding and treatment of spinal cord injuries, potentially leading to better outcomes for patients.

Gender

ALL

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