Clinical trial NCT06654804: Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury
Official title: Contrast-Enhanced Ultrasound Biomarker for Prognostication and Guidance of Surgical Treatment in Acute Traumatic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Spinal Cord Injury
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Outcomes of all subjects who received contrast enhanced ultrasound imaging, to check perfusion during the surgical repair of an acute spinal cord injury.
timeFrame: Two years
Secondary outcomes:
measure: Determine the prognostic capacity of CEUS biomarker for acute tSCI and surgical outcomes/recovery in spine injury/surgery.
timeFrame: Two years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Christoph Hofstetter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: