Acute Spinal Cord InjuryPhase 4NCT06654804
Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury
A Phase 4 study testing Perflutren lipid in people with Acute Spinal Cord Injury, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- Perflutren lipid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to 15 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington Harborview Medical Center
Seattle, Washington, 98104
Amy M Anderson, 2067449364, amya9@uw.edu
Christoph P Hofstetter, MD PhD
About this study
Official title: Contrast-Enhanced Ultrasound Biomarker for Prognostication and Guidance of Surgical Treatment in Acute Traumatic Spinal Cord Injury
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.
Read the 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.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- Perflutren lipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren lipidDrug
Also called Definity
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.
| Study group | Role | What they receive |
|---|---|---|
| Contrast-enhanced ultrasound in traumatic spinal cord injury | Experimental | A bolus IV injection of Perflutren lipid contrast agent will be given. Continuous imaging will be obtained. Receives: Drug: Perflutren lipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (1)
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start28 Sep 2023
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Christoph Hofstetter, University of Washington
- Investigators
- Christoph Hofstetter, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654804
- Sponsor's protocol ID
- STUDY00017544
- Status last verified
- Apr 2025
- First submitted
- 26 May 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Ultrasound Biomarker for Prognostication and Guidance of Surgical Treatment in Acute Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06654804
- Acronym / sponsor ID
- STUDY00017544
- Conditions
- Acute Spinal Cord Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-enhanced ultrasound in traumatic spinal cord injury | Experimental | Drug: Perflutren lipidA bolus IV injection of Perflutren lipid contrast agent will be given. Continuous imaging will be obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perflutren lipidAlso: DefinityBolus 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. | Drug | Contrast-enhanced ultrasound in traumatic spinal cord injury |
Primary outcome
Outcomes of all subjects who received contrast enhanced ultrasound imaging, to check perfusion during the surgical repair of an acute spinal cord injury.
Time frame: Two years
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.
1 secondary outcome
Determine the prognostic capacity of CEUS biomarker for acute tSCI and surgical outcomes/recovery in spine injury/surgery.
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Hofstetter, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perflutren lipid in people with Acute Spinal Cord Injury, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Anderson (206-744-9364, amya9@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcomes of all subjects who received contrast enhanced ultrasound imaging, to check perfusion during the surgical repair of an acute spinal cord injury. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.