Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury

NCT06654804 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00017544
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Outcomes of all subjects who received contrast enhanced ultrasound imaging, to check perfusion during the surgical repair of an acute spinal cord injury.

  Knowledge of spinal cord hypoperfusion will allow the physician to optimize the hemodynamic condition of acute spinal cord injury and potentially improve outcomes. The investigators plan to use contrast-enhanced ultrasound to determine decreased blood flow in the spinal cord at the site of injury, during the routine surgery that these patients require to decompress and stabilize their injured spine.

  Two years

Secondary Outcomes (1)

• Determine the prognostic capacity of CEUS biomarker for acute tSCI and surgical outcomes/recovery in spine injury/surgery.

  Two years

Study Arms (1)

Contrast-enhanced ultrasound in traumatic spinal cord injury

EXPERIMENTAL

A bolus IV injection of Perflutren lipid contrast agent will be given. Continuous imaging will be obtained.

Drug: Perflutren lipid

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.

Also known as: Definity

Contrast-enhanced ultrasound in traumatic spinal cord injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Interventions

perflutren

Study Officials

• Christoph Hofstetter, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Anderson

CONTACT

206-744-9364; amya9@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: Neurological Surgery

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: October 23, 2024
• Study Start: September 28, 2023
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)