Phase 4
N=267
BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury
Abdominal Trauma
Bottom Line
View on ClinicalTrials.gov: NCT05025449 ↗Enrolled (actual)
267
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives — 18; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Focused Assessment with Sonography for Trauma (FAST) (Diagnostic_test); Bubble-Enhanced FAST (BEFAST) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives |
18; 20 | — |
| PRIMARY Specificity of Detecting Solid Organ Injury Measured as the Number of True Negatives |
214; 216 | — |
| PRIMARY Number of Enrolled Participants With Successful Exams |
263; 245 | — |
| PRIMARY Percent Agreement Between Raters |
82.6; 76.2 | — |
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.
Eligibility Criteria
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 120 despite initial resuscitation)
Data sourced from ClinicalTrials.gov (NCT05025449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.