RecruitingPhase 4NCT06654804

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

Contrast-Enhanced Ultrasound Biomarker for Prognostication and Guidance of Surgical Treatment in Acute Traumatic Spinal Cord Injury

Sponsor

University of Washington

Enrollment

50 participants

Start Date

Sep 28, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Spinal Cord Injury

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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

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Interventions

DRUGPerflutren 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.