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

NCT05025449 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00100619
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Trauma

Keywords

Ultrasound contrast; Solid organ injury; Blunt abdominal trauma

Outcome Measures

Primary Outcomes (4)

• 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.

  1 Day of exam

• 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.

  1 Day of exam

• 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.

  1 Day of exam

• 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.

  1 Day of exam

Study Arms (1)

Non-enhanced FAST exam followed by BEFAST exam

EXPERIMENTAL

Participants in the emergency department with hemodynamically stable blunt abdominal trauma will receive the standard of care Focused Assessment with Sonography for Trauma (FAST) exam followed by a Bubble-Enhanced FAST exam.

Diagnostic Test: Focused Assessment with Sonography for Trauma (FAST); Drug: Bubble-Enhanced FAST (BEFAST)

Interventions

Focused Assessment with Sonography for Trauma (FAST) DIAGNOSTIC_TEST

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.

Non-enhanced FAST exam followed by BEFAST exam

Bubble-Enhanced FAST (BEFAST) DRUG

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.

Also known as: Lumason

Non-enhanced FAST exam followed by BEFAST exam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Abdominal Injuries

Interventions

Focused Assessment with Sonography for Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Laura Oh, MD
• Organization: Emory University

laura.oh@emory.edu

404-778-1709

Study Officials

• Laura Oh, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 27, 2021
• Study Start: September 30, 2021
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available for sharing beginning 9 months after study publication and ending 36 months after article publication.
• Access Criteria: Individual participant data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the approved proposal. Proposals should be directed to laura.oh@emory.edu. To gain access, data requestors will need to sign a data use agreement.

Locations

US (1)