Understanding spinal cord hemorrhage after injury using MRI
Characterizing Hemorrhage in Acute Spinal Cord Injury With MRI
NA · University of British Columbia · NCT04758377
This study is testing how managing blood pressure and using blood thinners affects bleeding in the spinal cord of people who have had a recent neck injury.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia (other) |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT04758377 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate how hemorrhage within the spinal cord following a traumatic injury is affected by mean arterial pressure (MAP) management with vasopressors and the use of anticoagulants for venous thromboembolism (VTE) prevention. It will be a single-center, prospective observational study focusing on patients with acute cervical spinal cord injuries. Participants will undergo magnetic resonance imaging (MRI) to assess the extent of hemorrhage in relation to their treatment. The study will enroll patients who meet specific criteria within 24 hours of their injury.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 or older with acute traumatic spinal cord injuries at specific cervical levels and a baseline impairment scale grade of A, B, or C.
Not a fit: Patients with spinal cord injuries due to infections, metabolic conditions, or those with contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with acute spinal cord injuries, potentially enhancing recovery outcomes.
How similar studies have performed: While the approach of using MRI to assess hemorrhage in spinal cord injuries is established, the specific focus on MAP and VTE prophylaxis in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute tSCI injury involving bony spinal levels between C0 and T1 * Baseline Asia Impairment Scale (AIS) grade of A, B, or C * Admission to study site within 24 hours of injury * Male or female age 19 or older * Able and willing to provide informed consent Exclusion Criteria: * Pathological fracture due to metabolic condition or neoplasia * Spinal cord injury due to infection * Presence of pacemaker, aneurysm clip or other device which is a contraindication to MRI * BMI \> 40 and unable to fit within the MRI scanner * Multiple life threatening injuries (ISS \>16) that make transport to MRI not in the patient's best interest * Any condition that, at the time of admission, prevents a complete ISNCSCI assessment from being performed
Where this trial is running
Vancouver, British Columbia
- Vancouver General Hospital — Vancouver, British Columbia, Canada (RECRUITING)
Study contacts
- Principal investigator: Brian Kwon, MD — University of British Columbia
- Study coordinator: Allan Aludino
- Email: allan.aludino@vch.ca
- Phone: 604-875-4111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Spinal Cord Haemorrhage, vasopressors, magnetic resonance imaging