Phase 4
N=27
tSCI Contrast Enhanced Ultrasound Study
Acute Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT04056988 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Feasibility of Intraoperative Contrast-enhanced Ultrasound in Acute Traumatic Spinal Cord Injury - Number of Participants With Successful Intraoperative Contrast-enhanced Ultrasound in Acute Traumatic Spinal Cord Injury — 27 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Perflutren Lipid Microsphere (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Intraoperative Contrast-enhanced Ultrasound in Acute Traumatic Spinal Cord Injury - Number of Participants With Successful Intraoperative Contrast-enhanced Ultrasound in Acute Traumatic Spinal Cord Injury |
27 | <0.05 sig |
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 hypo-perfusion of the spinal cord and exacerbates the severity of the injury. This is also referred to as secondary injury. Thus, knowledge of spinal cord hypo-perfusion would allow the treating physician to optimize the hemodynamic condition of patients with acute spinal cord injury and potentially improve functional outcomes. The investigators plan to use contrast-enhanced ultrasound (CEUS) to determine the decrease of 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 tSCI.
Eligibility Criteria
Inclusion Criteria
- >18
- Male or Female
- Acute <72 hours spinal cord injury (ASIA) grade A to D
- Medically stable to undergo routine decompression and spinal realignment
Exclusion Criteria
- <18 years of age
- Not clinically stable for spinal surgery
- Traumatic Brain Injury
- Known sensitivity to lipid microsphere or its components i.e., (PEG).
- A history of anaphylactoid reactions from ultrasound-enhancing agents
Data sourced from ClinicalTrials.gov (NCT04056988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.