drugset / Trial / NCT05025449

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

NCT05025449

NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2021-09-30
Primary completion
2023-09-14
Completion
2023-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumason Diagnostic / imaging agent 2.4 ml Intravenous

Indications

No indication recorded.