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Contrast Enhanced Ultrasound for Spinal Cord Injury

Phase 4
Recruiting
Led By Christoph P Hofstetter, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute <72 hours spinal cord injury
Medically stable to undergo routine decompression and spinal realignment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intra-operative
Awards & highlights

Study Summary

This trial will use ultrasound to look for decreased blood flow in the spinal cord at the site of injury in order to improve treatment for patients with tSCI.

Who is the study for?
This trial is for men and women with a recent spinal cord injury (less than 72 hours old) who are medically stable enough to undergo routine spine surgery. They should have an ASIA grade of A to D, indicating varying levels of impairment. People under 18 or those not stable for surgery, as well as individuals with traumatic brain injuries, cannot participate.Check my eligibility
What is being tested?
The study tests the use of contrast-enhanced ultrasound (CEUS) during routine spine surgery in patients with acute spinal cord injury. CEUS will be used to detect reduced blood flow at the injury site which could inform treatment decisions and potentially improve outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, contrast agents like Perflutren Lipid Microsphere can sometimes cause allergic reactions, discomfort at the injection site, or changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a spinal cord injury in the last 72 hours.
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I am medically fit for spine surgery.
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My spinal injury is classified between ASIA A to D.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intra-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and intra-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Use of CEUS to improve post operative outcomes in acute spinal cord injury

Trial Design

1Treatment groups
Experimental Treatment
Group I: Acute spinal cord injury patients to undergo contrast-enhancedExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perflutren
FDA approved

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,736 Total Patients Enrolled
Christoph P Hofstetter, MDPrincipal InvestigatorUniversity of Washington

Media Library

Perflutren Lipid Microsphere Clinical Trial Eligibility Overview. Trial Name: NCT04056988 — Phase 4
Spinal Cord Injury Research Study Groups: Acute spinal cord injury patients to undergo contrast-enhanced
Spinal Cord Injury Clinical Trial 2023: Perflutren Lipid Microsphere Highlights & Side Effects. Trial Name: NCT04056988 — Phase 4
Perflutren Lipid Microsphere 2023 Treatment Timeline for Medical Study. Trial Name: NCT04056988 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enrolled in this clinical trial thus far?

"Affirmative, the trial is currently recruiting participants according to clinicaltrials.gov's records. This project was first published on July 31st 2018 and last updated on August 12th 2019; it aims to recruit 30 patients from 1 location."

Answered by AI

What risk factors are associated with Perflutren Lipid Microsphere administration?

"Backed by a phase 4 trial, our team at Power is confident in the safety of Perflutren Lipid Microsphere and rated it with a 3 on the scale."

Answered by AI

What previous experiments were conducted involving Perflutren Lipid Microsphere?

"Currently, 19 Perflutren Lipid Microsphere clinical trials are active with 1 of them currently in Phase 3. Philadelphia, Pennsylvania is the primary hub for these studies but 26 different cities across America host participating sites."

Answered by AI

Are contemporary participants allowed to register for this experiment?

"Affirmative. Clinicaltrials.gov communicates that this clinical trial is still open to volunteers, having been posted on July 31st 2018 and last modified August 12th 2019. The research seeks out 30 individuals from a single medical centre."

Answered by AI

What pathologies are traditionally managed with Perflutren Lipid Microsphere?

"Primarily administered during echocardiography, Perflutren Lipid Microsphere can also be taken to address multiple cardiovascular conditions as well as left ventricular imaging."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
tSCI Contrast Enhanced Ultrasound Study
Christoph Hofstetter 2018. "tSCI Contrast Enhanced Ultrasound Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04056988.
~3 spots leftby Dec 2024
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