Recruiting

Contrast-enhanced Ultrasound

Sponsor:

University of Washington

Code:

NCT06654804

Conditions

Acute Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Perflutren lipid

Study Details

Brief summary:

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.

Conditions

Acute Spinal Cord Injury

Study ID

NCT06654804

Start date

Sep 28, 2023

Status verified date

Apr, 2025

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age minimum
  • Acute spinal cord injury fpr less than 24 hours
  • Injury ranging from mild spinal cord injury where motor function is preserved (AIS A) to complete injury where there is no motor or sensory function below the leel of the injury (AIS D)
  • Medically stable to undergo routine dorsal decompression, spinal realignment
  • and stabilizing with segmental instrumentation

Exclusion Criteria:

  • Younger than 18 years old
  • Neurological lower extremity exam missing or intact
  • Traumatic head injury with a Glasgow score of 11 or lower
  • Cord injury level caudal to T10 (thoracic spine level 10)
  • A known sensitivity to lipid microsphere or its components, such as polyethylene glycol (PEG)
  • A history of anaphylactoid reactions from ultrasound enhancing agents
  • A known history of cardiopulmonary conditions
  • Cardiac shunt

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Perflutren lipid

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.

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 and Locations

Central contacts

Amy Anderson

206-744-9364amya9@uw.edu

Locations

University of Washington Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Amy M Anderson

2067449364amya9@uw.edu

Principal Investigator:

Christoph P Hofstetter, MD PhD

More Information

Sponsor

University of Washington

Last update posted

Apr 27, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University of Washington on 2025-04-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.