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Contrast Agent

Focused Assessment with Sonography for Trauma (FAST) for Internal bleeding (BEFAST Trial)

Phase 4

Waitlist Available

Led By Laura Oh, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day of exam

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether adding ultrasound contrast to the FAST exam (BEFAST) will improve its sensitivity for identifying solid organ injury in hemodynamically stable blunt abdominal trauma patients.

Eligible Conditions

Internal bleeding

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day of exam

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day of exam

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day of exam for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Enrolled Participants With Successful Exams

Percent Agreement Between Raters

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

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Non-enhanced FAST exam followed by BEFAST examExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Focused Assessment with Sonography for Trauma (FAST)

2021

Completed Phase 4

~270

1,2-Distearoyllecithin

FDA approved

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