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

PHASE4CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

September 30, 2021

Primary Completion Date

September 14, 2023

Study Completion Date

September 14, 2023

Conditions
Abdominal Trauma
Interventions
DIAGNOSTIC_TEST

Focused Assessment with Sonography for Trauma (FAST)

The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of Advanced Trauma Life Support (ATLS) protocol. After consent, a baseline FAST exam will be performed and documented. This FAST will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. The investigator will use a phased array or curvilinear transducer to record video of their baseline FAST exam.

DRUG

Bubble-Enhanced FAST (BEFAST)

Following the FAST exam and using the same machine, a BEFAST exam will be performed using a low mechanical index setting in contrast-specific imaging mode. A 2.4 mL IV dose of Lumason will be injected into the subject's IV, followed by saline flush. The contrast will be injected once for the right side of the body, and once for the left side of the body looking for disruptions in the normal enhancement pattern and evidence of active bleeding. To examine the right side of the body: the liver will be imaged first in arterial phase, followed by the right kidney, before returning to image the liver in venous phase. To examine the left side of the body: the pancreas will be imaged first, followed by the kidney and the spleen. The investigator will note evidence of solid organ injury, free fluid, or active extravasation on both sides of the body; lacerations will be graded by the American Association for the Surgery of Trauma (AAST) criteria.

Trial Locations (1)

30303

Grady Memorial Hospital, Atlanta

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Emory University

OTHER

NCT05025449 - BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury | Biotech Hunter | Biotech Hunter