Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of Washington
- Study ID
- NCT06654804
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Acute Spinal Cord Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Perflutren lipid — DRUGBolus injection of contrast during spinal decompression surgery for the treatment of traumatic spinal cord injury. Ultrasound imaging will then be used to collect images of the spinal cord injury to record perfusion, inflow and washout.
Study Details
Patients with traumatic spinal cord injury (tSCI) often suffer from spinal cord swelling inside the thecal sac, which contains the spinal cord and surrounding fluid, leading to increased pressure on the spinal cord tissue and decreased spinal cord blood flow at the site of injury. The combination of increased pressure and decreased blood flow causes vascular hypoperfusion of the spinal cord and exacerbates the severity of injury. This is also referred to as secondary injury. Thus, knowledge of spinal cord hypoperfusion would allow the treating physician to optimize the hemodynamic condition of the patient with acute spinal cord injury and potentially improve functional outcomes.
Key Dates
- Start date
- Sep 28, 2023
- Status verified
- Apr 2025
- Primary completion
- Sep 15, 2027
- Completion
- Sep 15, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Contrast-enhanced ultrasound in traumatic spinal cord injuryA bolus IV injection of Perflutren lipid contrast agent will be given. Continuous imaging will be obtained.
Primary Outcome Measure
Outcomes of all subjects who received contrast enhanced ultrasound imaging, to check perfusion during the surgical repair of an acute spinal cord injury. [ Time Frame: Two years ]
Central Contacts
- Amy Anderson206-744-9364
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Washington Harborview Medical Center | Seattle | Washington | 98104 | Christoph P Hofstetter, MD PhD (PRINCIPAL_INVESTIGATOR) |
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