CompletedPhase 4

BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury

United States267 participantsStarted 2021-09-30

Plain-language summary

The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly enhance the evaluation of the trauma patient with acute intra-abdominal injury through the use of intravascular microbubbles that allow direct visualization of lacerations to solid organs. European studies have demonstrated that ultrasound contrast markedly improves the sensitivity of ultrasound in detecting solid organ injury, when the exam is performed in the radiology suite. The researchers hypothesize that the bubble-enhanced FAST or BEFAST exam will be more sensitive than traditional FAST for identification of solid organ injury in hemodynamically stable blunt abdominal trauma patients when performed by emergency providers.

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: * Clinical suspicion of intra-abdominal injury * Presentation within 24 hours of injury * Planned CT of the abdomen/pelvis within 24 hours * Ability of patient or legally authorized representative to provide informed consent Exclusion Criteria: * Co-existing penetrating abdominal injury * Known hypersensitivity reaction to contrast agent * Pregnant patients * Prisoners * No appropriate IV Line able to be inserted * Hemodynamic instability at time of enrollment (sustained systolic blood pressure \< 90 mm Hg or sustained heart rate (HR) \>120 despite initial resuscitation)

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

Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives

Timeframe: 1 Day of exam

Specificity of Detecting Solid Organ Injury Measured as the Number of True Negatives

Timeframe: 1 Day of exam

Number of Enrolled Participants With Successful Exams

Timeframe: 1 Day of exam

Percent Agreement Between Raters

Timeframe: 1 Day of exam

Trial details

NCT IDNCT05025449

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-14

Results submitted2024-09-12

View on ClinicalTrials.gov More Abdominal Trauma trials

Plain-language summary

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.

What they're measuring

Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives

Timeframe: 1 Day of exam

Specificity of Detecting Solid Organ Injury Measured as the Number of True Negatives

Timeframe: 1 Day of exam

Number of Enrolled Participants With Successful Exams

Timeframe: 1 Day of exam

Percent Agreement Between Raters

Timeframe: 1 Day of exam