Acute Spinal Cord InjuryPhase 4NCT04056988
tSCI Contrast Enhanced Ultrasound Study
A Phase 4 study testing Perflutren Lipid Microsphere 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 Microsphere
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 20 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or Female
- Acute <72 hours spinal cord injury (ASIA) grade A to D
- Medically stable to undergo routine decompression and spinal realignment
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Utilizing Contrast-enhanced Ultrasound (CEUS) to Assess Critically Hypo Perfused Spinal Cord Tissue After 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 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.
Read the detailed description
Patients presenting to the Harborview Emergency Room with acute traumatic spinal cord injury (tSCI) will be recruited to undergo contrast-enhanced ultrasound (CEUS) during routine surgery for decompression and stabilization of their injury.
Traumatic spinal cord injury (tSCI) develops in two phases. The primary injury is characterized by direct mechanical destruction of cells, nerve fibers, and blood vessels. The secondary injury phase represents the downstream biological effects of the loss of blood flow in the injury center as well as significant hypoperfusion in the surrounding penumbral zone. This process is associated with cytotoxic spinal cord edema, which causes a rise in tissue pressure within the contused spinal cord. While experimental studies demonstrate that spinal cord tissue damage due to primary injury is often remarkably limited, the cascade of biochemical and molecular processes that comprise secondary injury often exacerbate and define the extent of injury to the patient.
Accordingly, two routinely performed clinical treatment strategies aim to mitigate the effects of secondary injury by improving the local tissue perfusion of the contused spinal cord. First, surgical decompression of the spinal cord is recommended within 24 hours after injury, as it may improve functional outcomes. Second, trauma guidelines recommend the maintenance of the mean arterial blood pressure at 85 - 90 Hg for the first 7 days after acute spinal cord injury.
Despite these interventions and a tremendous research effort to develop neuroprotective therapies targeting the hypoperfused "rescue-able" penumbral zone, there are no clinically efficacious techniques to improve functional outcomes following tSCI. The investigators believe that a lack of clinical biomarkers for the hypoperfused "rescue-able" penumbral zone is the main roadblock to the development of novel therapeutic procedures and therapies. This motivates a search for a biomarker for tSCI that can guide surgical and critical care interventions. The investigators seek to develop an ultrasound-based biomarker for tSCI that is sensitive to the underlying tissue pathology and predictive of clinical outcomes.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- Perflutren Lipid Microsphere
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren Lipid MicrosphereDrug
Also called DEFINITY®
Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Acute spinal cord injury patients to undergo contrast-enhanced | Experimental | Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.
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 DEFINITY® contrast agent (1.5ml DEFINITY®/8.5ml saline) will be given. Continuous imaging will be obtained to record contrast inflow and washout. Receives: Drug: Perflutren Lipid Microsphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Feasibility was defined as successful intravenous administration of perflutren lipid microsphere contrast agent and acquisition of interpretable intraoperative contrast-enhanced ultrasound (CEUS) perfusion imaging during spinal decompressive surgery in patients with acute traumatic spinal cord injury.
Measured: Operative period to one-week or hospital discharge (first occurring event)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start31 Jul 2018
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Hofstetter, University of Washington
- Investigators
- Christoph P Hofstetter, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056988
- Sponsor's protocol ID
- STUDY00003267
- Other IDs
- CDMRP-Log Number SC170209
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2019
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Contrast-enhanced Ultrasound (CEUS) to Assess Critically Hypo Perfused Spinal Cord Tissue After Injury
- ClinicalTrials.gov ID
- NCT04056988
- Acronym / sponsor ID
- STUDY00003267
- Conditions
- Acute Spinal Cord Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Posted 29 Apr 2026
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 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.
Detailed description
Patients presenting to the Harborview Emergency Room with acute traumatic spinal cord injury (tSCI) will be recruited to undergo contrast-enhanced ultrasound (CEUS) during routine surgery for decompression and stabilization of their injury.
Traumatic spinal cord injury (tSCI) develops in two phases. The primary injury is characterized by direct mechanical destruction of cells, nerve fibers, and blood vessels. The secondary injury phase represents the downstream biological effects of the loss of blood flow in the injury center as well as significant hypoperfusion in the surrounding penumbral zone. This process is associated with cytotoxic spinal cord edema, which causes a rise in tissue pressure within the contused spinal cord. While experimental studies demonstrate that spinal cord tissue damage due to primary injury is often remarkably limited, the cascade of biochemical and molecular processes that comprise secondary injury often exacerbate and define the extent of injury to the patient.
Accordingly, two routinely performed clinical treatment strategies aim to mitigate the effects of secondary injury by improving the local tissue perfusion of the contused spinal cord. First, surgical decompression of the spinal cord is recommended within 24 hours after injury, as it may improve functional outcomes. Second, trauma guidelines recommend the maintenance of the mean arterial blood pressure at 85 - 90 Hg for the first 7 days after acute spinal cord injury.
Despite these interventions and a tremendous research effort to develop neuroprotective therapies targeting the hypoperfused "rescue-able" penumbral zone, there are no clinically efficacious techniques to improve functional outcomes following tSCI. The investigators believe that a lack of clinical biomarkers for the hypoperfused "rescue-able" penumbral zone is the main roadblock to the development of novel therapeutic procedures and therapies. This motivates a search for a biomarker for tSCI that can guide surgical and critical care interventions. The investigators seek to develop an ultrasound-based biomarker for tSCI that is sensitive to the underlying tissue pathology and predictive of clinical outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute spinal cord injury patients to undergo contrast-enhanced | Experimental | Drug: Perflutren Lipid MicrospherePerflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. 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 DEFINITY® contrast agent (1.5ml DEFINITY®/8.5ml saline) will be given. Continuous imaging will be obtained to record contrast inflow and washout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18
- Male or Female
- Acute <72 hours spinal cord injury (ASIA) grade A to D
- Medically stable to undergo routine decompression and spinal realignment
Key exclusion criteria (5 listed)
- <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
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 Lipid MicrosphereAlso: DEFINITY®Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. | Drug | Acute spinal cord injury patients to undergo contrast-enhanced |
Primary outcome
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
Time frame: Operative period to one-week or hospital discharge (first occurring event)
Feasibility was defined as successful intravenous administration of perflutren lipid microsphere contrast agent and acquisition of interpretable intraoperative contrast-enhanced ultrasound (CEUS) perfusion imaging during spinal decompressive surgery in patients with acute traumatic spinal cord injury.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Christoph P Hofstetter, MD 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 Microsphere 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Operative period to one-week or hospital discharge (first occurring event)). 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 13 Jul 2026.