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

BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury in Hemodynamically Stable Blunt Abdominal Trauma

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05025449
Acronym
BEFAST
Enrollment
267
Registered
2021-08-27
Start date
2021-09-30
Completion date
2023-09-14
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Trauma

Keywords

Ultrasound contrast, Solid organ injury, Blunt abdominal trauma

Brief 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.

Detailed description

Blunt abdominal trauma, whether from motor vehicle crash, assault, fall, or recreational injury, is a leading cause of morbidity and mortality. According to the 2016 National Trauma Database, 12% of all patients with trauma admissions had abdominal trauma, the majority of which is blunt. The diagnosis of intra-abdominal injury due to blunt abdominal trauma can be challenging. The physical exam is unreliable in patients with altered mental status or with impairment due to drugs or alcohol. While computed tomography (CT) can rapidly and accurately diagnose injury, emergency physicians have raised concerns that the use of CT has become overly liberal. The risks of overutilization of CT in hemodynamically stable blunt abdominal trauma include increased health care costs, lengthy stays in the emergency department, risks of contrast-induced nephropathy and radiation-induced malignancy, and patient anxiety when incidentalomas are discovered that need extensive and often unnecessary workup. The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of the 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. In 2016, the Food and Drug Administration (FDA) approved Lumason (sulfur hexafluoride lipid-type A microsphere) for characterization of focal liver lesions with CEUS in both adult and pediatric patients, opening new areas of research in the United States. Lumason is a second generation contrast agent that is more stable than previous ultrasound contrast agents and does not require refrigeration. Although approved for intravascular and intravesical use, Lumason's use in a trauma exam is off-label in the United States. After participants provide informed consent, a baseline FAST exam will be performed and documented. This exam will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. If not already placed, an intravenous line will be established according to standard practice for trauma patients. Following the FAST exam, a bubble-enhanced FAST (BEFAST) exam will be performed using Lumason as the contrast agent. As part of the standard of care, participants will have a CT exam performed within 24 hours, which will provide the gold standard for diagnosis of solid organ trauma.

Interventions

DIAGNOSTIC_TESTFocused 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.

DRUGBubble-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.

Sponsors

United States Department of Defense
CollaboratorFED
Emory University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

The interpretation of the point-of-care emergency medicine (EM) physician (blind to the CT read) will be compared to the interpretations of board-certified radiologists (also blind to the CT read) for the presence or absence of solid organ injury.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives1 Day of examThe performance of the study exams will be assessed as the number of correctly identified solid organ injuries (true positives) detected by FAST exam and BEFAST exam. The presence of injury will be determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.
Specificity of Detecting Solid Organ Injury Measured as the Number of True Negatives1 Day of examThe performance of the study exams is assessed as the percentage of correctly identified lack of solid organ injuries (true negatives) detected by FAST and BEFAST exams. The presence of solid organ injury is determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.
Number of Enrolled Participants With Successful Exams1 Day of examThe number of successful, completed exams is used to determine whether emergency physicians can incorporate BEFAST evaluation at the point-of-care. The exam is considered complete if the participant tolerates the study without experiencing severe adverse events to contrast and the participant allows the provider to complete the scan, and if the exam results in images of adequate quality to answer the focused clinical question.
Percent Agreement Between Raters1 Day of examEmergency physicians' interpretations of the ultrasound exams are compared to interpretations of board-certified radiologists for the presence or absence of solid organ injury, free fluid, or active extravasation. Injured organs are graded per American Association for the Surgery of Trauma (AAST) criteria.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from Grady Memorial Hospital in Atlanta, Georgia, USA. Participant enrollment began September 30, 2021 and the final study visit occurred on September 14, 2023.

Participants by arm

ArmCount
Non-enhanced FAST Exam Followed by BEFAST Exam
Participants in the emergency department with hemodynamically stable blunt abdominal trauma receiving the standard of care Focused Assessment with Sonography for Trauma (FAST) exam followed by a Bubble-Enhanced FAST exam.
267
Total267

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPatient emergently taken to operating room1
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicNon-enhanced FAST Exam Followed by BEFAST Exam
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
64 Participants
Age, Categorical
Between 18 and 65 years
203 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
253 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
4 Participants
Race (NIH/OMB)
Black or African American
160 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants
Race (NIH/OMB)
White
89 Participants
Region of Enrollment
United States
267 Participants
Sex: Female, Male
Female
104 Participants
Sex: Female, Male
Male
163 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2670 / 265
other
Total, other adverse events
0 / 2672 / 265
serious
Total, serious adverse events
0 / 2670 / 265

Outcome results

Primary

Number of Enrolled Participants With Successful Exams

The number of successful, completed exams is used to determine whether emergency physicians can incorporate BEFAST evaluation at the point-of-care. The exam is considered complete if the participant tolerates the study without experiencing severe adverse events to contrast and the participant allows the provider to complete the scan, and if the exam results in images of adequate quality to answer the focused clinical question.

Time frame: 1 Day of exam

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Non-enhanced FAST ExamNumber of Enrolled Participants With Successful Exams263 Participants
BEFAST ExamNumber of Enrolled Participants With Successful Exams245 Participants
Primary

Percent Agreement Between Raters

Emergency physicians' interpretations of the ultrasound exams are compared to interpretations of board-certified radiologists for the presence or absence of solid organ injury, free fluid, or active extravasation. Injured organs are graded per American Association for the Surgery of Trauma (AAST) criteria.

Time frame: 1 Day of exam

Population: Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.

ArmMeasureValue (NUMBER)
Non-enhanced FAST ExamPercent Agreement Between Raters82.6 percentage of agreement
BEFAST ExamPercent Agreement Between Raters76.2 percentage of agreement
Primary

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

The performance of the study exams will be assessed as the number of correctly identified solid organ injuries (true positives) detected by FAST exam and BEFAST exam. The presence of injury will be determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.

Time frame: 1 Day of exam

Population: Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Non-enhanced FAST ExamSensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives18 Participants
BEFAST ExamSensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives20 Participants
Primary

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

The performance of the study exams is assessed as the percentage of correctly identified lack of solid organ injuries (true negatives) detected by FAST and BEFAST exams. The presence of solid organ injury is determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.

Time frame: 1 Day of exam

Population: Two participants were withdrawn from the study after having the FAST exam and before having the BEFAST exam.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Non-enhanced FAST ExamSpecificity of Detecting Solid Organ Injury Measured as the Number of True Negatives214 Participants
BEFAST ExamSpecificity of Detecting Solid Organ Injury Measured as the Number of True Negatives216 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026