Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury (NCT06654804) | Clinical Trial Compass
RecruitingPhase 4
Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury
United States50 participantsStarted 2023-09-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Outcomes of all subjects who received contrast enhanced ultrasound imaging, to check perfusion during the surgical repair of an acute spinal cord injury.