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

ConditionAcute Spinal Cord Injury

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Washington

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Contrast-enhanced ultrasound in traumatic spinal cord injuryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Two years

Secondary outcomes

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

Measure the outcomes of spinal cord decompression surgery in patient population. The protocol is designed to develop a standardized operating procedure for prognostic intraoperative biomarker acquisition and readout. Inter- and intra-rater reliability will be scored, and the CEUS markers will be validated with tSCI severity reference standards such as MRI biomarkers and AIS score. Aim 2 of the study will also focus on determining the prognostic capacity for chronic neurological outcome.

Time frame

Two years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov

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