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New treatment option for Acute Spinal Cord Injury
Official title Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury
ClinicalTrials.gov ID: NCT06654804
What this study is testing
What is Perflutren lipid?
Perflutren lipid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute spinal cord injury.
Also referred to as Definity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Medically stable to undergo routine dorsal decompression, spinal realignment
- and stabilizing with segmental instrumentation
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.