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 — DRUG
    Bolus 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 injury
    A 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Harborview Medical CenterSeattleWashington98104
Amy M Anderson
2067449364
Christoph P Hofstetter, MD PhD (PRINCIPAL_INVESTIGATOR)

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