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

NCT ID: NCT06654804

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-28
• Study Completion Date: 2027-09-15

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.

Detailed Description

The investigators plan to use contrast-enhanced ultrasound (CEUS) to determine a decrease in the 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. This may help the investigators to determine the efficacy of certain treatments in improving blood flow and patients suffering from traumatic spinal cord injury.

Patients presenting to Harborview Medical Center with a diagnosis of traumatic spinal cord injury will be screened for participation. Many of these patients require emergent or urgent surgery for decompression of the spinal cord and stabilization of the spine.

The patient will be taken to the operating room as per routine. After completion of the key elements of surgery, namely posterior decompression, and stabilization of the cervical or thoracic spinal cord, CEUS will be performed. Importantly, the proposed trial does not prolong the time before surgical decompression and stabilization are accomplished. Moreover, it does not increase the invasiveness of the procedure as it is collected at the final stage of the routine procedure. A hand-held intraoperative ultrasound probe will be used to collect sagittal images of the spinal cord centered above the spinal cord injury. A bolus IV injection of the contrast agent will be given. Continuous imaging will be obtained to record contrast inflow and washout.

Post-operatively, the participant will receive routine MRI imaging within one week (health status permitting) and one year.

Conditions

Acute Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Perflutren lipid

Intervention Type: 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.

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.

Intervention Type: DRUG

Other Intervention Names

Definity

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Christoph Hofstetter

Associate Professor: Neurological Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Hofstetter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Harborview Medical Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Anderson

Role: CONTACT

amya9@uw.edu

206-744-9364

Facility Contacts

Amy M Anderson

Role: primary

amya9@uw.edu

2067449364

Other Identifiers

STUDY00017544

Identifier Type: -

Identifier Source: org_study_id