Conditions: Abdominal Trauma
Keywords: Ultrasound contrast Solid organ injury Blunt abdominal trauma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 267
Healthy volunteers: no

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.

Arms:
arm 1: 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.

Interventions: intervention 1: Focused Assessment with Sonography for Trauma (FAST) intervention 2: Bubble-Enhanced FAST (BEFAST)
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document:
Prot_SAP_001.pdf: 
Study Protocol 
 
TITLE: BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid 
Organ Injury in Hemodynamically Stable Blunt Abdominal Trauma 
 
NCT NUMBER: NCT05025449 
 
Protocol Date: December 21, 2021 


Title Page
Full Study Title: BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ 
Injury in Hemodynamically Stable Blunt Abdominal Trauma
Short Study Title: BEFAST
Laura Oh, MD, Department of Emergency Medicine
Sponsor: Department of Defense; Sponsor # 00003566, EPEX # 0000063966
Protocol Version 7.0; 12/21/21


2. External Collaborators: n/a
3. Precis/Abstract
Title: BEFAST: Bubble-Enhanced FAST for the Evaluation of Solid Organ Injury in 
Patients with Hemodynamically Stable Blunt Abdominal Trauma 
Rationale: The Focused Assessment with Sonography for Trauma (FAST) exam is 
widely used and accepted as part of 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. CEUS, however, has never been validated in the US in the hands of emergency 
medicine providers. 
Research Hypothesis: We hypothesize that the bubble-enhanced 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. 
Specific Aims: 
Objective 1: To determine if contrast-enhanced, i.e. bubble-enhanced FAST (BEFAST) 
outperforms non-enhanced FAST in the evaluation of solid organ injury in 
hemodynamically stable blunt abdominal trauma patients when performed by frontline 
providers using CT as gold-standard. 
Objective 2: To determine whether emergency physicians can incorporate BEFAST 
evaluation at the point-of-care in a trauma evaluation of a hemodynamically stable adult 
blunt abdominal trauma patient. 
Objective 3: To determine the inter-rater reliability between bedside emergency 
physicians and radiologists for identifying solid organ injury with BEFAST. 
Significance: A specific concern that the BEFAST exam addresses is the low sensitivity 
of FAST for identification of solid organ injury in the absence of hemoperitoneum. If the 
proposed work is successful we will demonstrate that the BEFAST exam adds critical 
information at the point-of-care by identifying intra-abdominal injury that would be 
missed by the traditional FAST exam. The BEFAST exam may be able to replace the 
FAST exam as a more sensitive screening tool of intra-abdominal injury. In addition, 
while CT remains the gold standard for blunt abdominal trauma, BEFAST has the 
potential to impact the field by providing an alternative imaging strategy to CT in cases 
of medical necessity (renal failure, allergy to contrast dye), patient preference (pediatric 
or pregnant patient), or limited resource (surge/MCI, austere environment, international 
EM).


4. Introduction and Background
Our primary hypothesis is that the bubble-enhanced 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. The purpose of this study is to ascertain whether the BEFAST exam is a more 
sensitive screening tool than traditional FAST exam. BEFAST addresses a major 
limitation of conventional FAST in that it can identify lacerations to solid organs even in 
the absence of hemoperitoneum. Acceptance of the BEFAST exam as an appropriate 
alternative to CT in select situations may positively impact patient care by leading to 
decreased CT utilization and a change to current trauma algorithms.
Blunt abdominal trauma - whether from motor vehicle crash, assault, fall, or recreational 
injury - is a leading cause of morbidity and mortality [1]. According to the 2016 National 
Trauma Database, 12 % of all patients with trauma admissions had abdominal trauma, the 
majority of which is blunt [2]. 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. Utilization of the FAST 
exam has dramatically improved clinical care by enabling frontline providers to screen 
for injury non-invasively.
While the FAST exam is considered a first line tool in the triage of hemodynamically 
unstable patients with abdominal trauma to CT scanner versus the OR, its inability to 
identify lacerations to the solid organs in the absence of hemoperitoneum limits its utility 
in the hemodynamically stable patient. A 2018 Cochran review noted substantial 
heterogeneity of reported sensitivity of the FAST exam; pooling results from 34 studies it 
estimated FAST sensitivity for abdominal trauma to be 68% and specificity to be 95% 
[3]. Most studies use free fluid as the only criteria for a positive FAST exam. When 
FAST is used to detect solid organ injury it is less sensitive; both McGahan et al and 
Rothlin et al. showed a sensitivity of 41% for the ability of FAST to detect solid organ 
injury [4-6].  In comparison, gold standard CT has a sensitivity of 97-98% and specificity 
of 97-99% for intra-abdominal injury [7]. The use of the BEFAST exam may bridge this 
diagnostic gap between FAST and CT if it can demonstrate improved sensitivity in 
detecting lacerations to liver, kidney, spleen, and pancreas. 
While CT can rapidly and accurately diagnose injury, emergency physicians have raised 
concerns that the use of CT has become overly liberal [8]. Over the last few decades there 
has been a paradigm shift in the management of solid organ trauma with increasingly 
nonoperative management of both low and high-grade injuries in hemodynamically stable 
patients [9-10]. 25% of all CTs are ordered through the ED, but less than 20% of 
abdominal CTs obtained in patients with blunt trauma have intra-abdominal injury, and 
less than 3% require a surgical intervention [7].
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 


[11]. And yet, CT usage in trauma patients has increased dramatically by 3.5-fold 
between 1995-2007 [12]. With the yearly rise in ED census and CT utilization, it is 
becoming an increasingly impractical and expensive strategy to “pan-scan” trauma 
patients without further risk stratification. This is especially true when the patient is 
hemodynamically stable and unlikely to need an operative intervention. Strategies for 
minimizing radiation burden of CT include use of clinical decision tools, guidelines for 
appropriate use such as the Image Wisely and Image Gently campaigns, reduced CT 
dosage, and technological innovations such as contrast-enhanced ultrasound [12-14]. 
Contrast-enhanced ultrasound uses microbubble contrast agents consisting of an inert gas 
surrounded by a stabilizing shell. The microbubbles reflect sound waves and enhance the 
ultrasound image. These gas-filled microspheres are about the size of a red blood cell and 
remain in the intravascular space; unlike CT contrast, microbubble contrast agents do not 
leak or diffuse into the tissue [15-6]. Microbubbles metabolize when they break via 
exhalation of the gas, and the shell is metabolized by the liver. The contrast is completely 
eliminated from the body within 10-15 min [17-8].
In 2016, the Food and Drug Administration (FDA) approved Lumason (sulfur 
hexafluoride lipidtype 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 [19]. Lumason is a second generation contrast agent that is more stable than 
previous ultrasound contrast agents and does not require refrigeration. Other currently 
approved indications include use in echocardiography and in evaluation of urinary reflux 
in children. Although approved for intravascular and intravesical use, Lumason’s use in 
trauma is off-label and an emerging application in the United States [12].
Previous European literature supports the superiority of CEUS to conventional ultrasound 
for the identification of solid organ injury. In a 2009 multi-center study by Catalano et al. 
of 156 patients, the use of contrast by radiologists improved the sensitivity and specificity 
of renal trauma seen on conventional US from 36% to 69% and from 98% to 99% [12]. 
For liver trauma, ultrasound contrast agents improved the sensitivity and specificity from 
68% to 84% and from 97% to 99% [12]. For splenic trauma, contrast improved the 
sensitivity and specificity from 77% to 93% and from 96% to 99% [12]. CEUS performs 
even better when used only for lowenergy isolated trauma where it has a sensitivity of up 
to 95% [20]. An example of a liver laceration seen on contrast-enhanced ultrasound vs 
conventional FAST is depicted in Figure 1.


Figure 1. Comparison of liver laceration seen with CEUS on left and no contrast on right
CEUS may also be used to grade injury to solid organs using AAST criteria. In a 2014 
study by Lv et al., two radiologists were able to classify contrast-enhanced images into 
mild, moderate, and severe injury with high inter-rater reliability (κ = 0.973) [21]. CEUS 
can also identify active extravasation as a pool of contrast or a jet outside of blood vessels 
[22]. In a 2011 study by Lv, et al., 392 patients with hepatic injury were examined by 
both CEUS and CT; CEUS detected extravasation in 16% of cases and had a similar 
performance to CT with sensitivity of 72% vs 81%. [23]. The presence of active bleeding 
is critical information in the management algorithm of blunt abdominal trauma and 
suggests the need for emergent surgical or interventional radiology consultation and/or 
treatment.
Contrast-enhanced ultrasound (CEUS) has the potential to enhance the diagnostic 
capabilities of point-of-care ultrasound while still offering the traditional advantages of 
ultrasound over other imaging modalities. These advantages include its portability, 
repeatability, lack of ionizing radiation, lack of necessity for labs prior to study, and lack 
of necessity for transport of the patient to the radiology suite. If the BEFAST outperforms 
the FAST exam in identification of intra-abdominal injury, our study would lay the 
groundwork for the argument that just as the FAST exam largely replaced DPL, the use 
of microbubble contrast agents in contrast-enhanced ultrasound is the next evolution in 
trauma triage. We wish to show that the BEFAST is a more advanced trauma screening 
tool. As providers become more comfortable with the BEFAST exam and the use of 
contrast in the trauma bay, CEUS may find an increasing role in decreasing the utilization 
of CT in select scenarios. CEUS may also play a role as a risk-stratification tool for 
disposition decisions to ICU vs floor via grading of injury by AAST criteria. Although 
CT with IV contrast provides the most information in the evaluation of intra-abdominal 
injury, CEUS may play a substantial role in the future in a multi-modal approach to 


trauma. Further investigation is needed to discover the capabilities and limitations of 
CEUS in the hands of emergency providers.
Our study is distinct from previous European literature because the CEUS exam would be 
performed and interpreted by emergency physicians rather than by radiologists. We wish 
to demonstrate the feasibility of this exam outside of the radiology suite because of the 
potential for BEFAST to impact patient care by enabling frontline providers to make real-
time clinical decisions at the bedside.
5. Objectives:
Objective 1: To determine if contrast-enhanced, i.e. bubble-enhanced FAST (BEFAST) 
outperforms non-enhanced FAST in the evaluation of solid organ injury in 
hemodynamically stable blunt abdominal trauma patients when performed by frontline 
providers using CT as gold-standard. 
Objective 2: To determine whether emergency physicians can incorporate BEFAST 
evaluation at the point-of-care in a trauma evaluation of a hemodynamically stable adult 
blunt abdominal trauma patient. 
Objective 3: To determine the inter-rater reliability between bedside emergency 
physicians and radiologists for identifying solid organ injury with BEFAST. 
6. Study Design and Methods:
This single center prospective study will enroll 267 adult patients with hemodynamically 
stable blunt abdominal trauma who present to a Level 1 ACS verified Trauma Center.
Inclusion Criteria: 
Age 18 and older
Clinical suspicion of intra-abdominal injury
Presentation within 24 hours of injury
Planned CT of the abdomen/pelvis within 24 hours
Ability of patient 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 HR >120 despite initial resuscitation) 
   


Study Interventions/Procedures:
1) Baseline Grayscale US Exam
2) Contrast Enhanced US exam with IV administration of LUMASON
3) Chart Review for abstraction of clinical and demographic data
Risks/discomforts:
Risks from ultrasound use are minimal – this modality does not use ionizing radiation. 
Most commonly the patient may complain of coldness of gel or minor discomfort from 
pressure of the ultrasound probe. 
The less common risks and discomforts expected in this study are (in 0.02% of patients):
Headache, nausea, dizziness, flushing, back pain, kidney pain, chest pain, shortness of 
breath, hypertension, mild allergic reactions
Rare but possible risks include: hypersensitivity to contrast resulting in low blood 
pressure (0.007% of patients). 
Potential benefits include: identification of injuries with BEFAST not seen with 
conventional FAST
Ultrasound studies will be performed by a team of ultrasound faculty who have 
attended a didactic session on the BEFAST exam and grading of solid organ injury by 
AAST criteria. They will be evaluated with a post-test to check for comprehension.
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. A 20g or larger intravenous line if not already 
placed, will be established according to standard practice for trauma patients. The 
investigator will use a phased array or curvilinear transducer to record video of their 
baseline FAST exam. The investigator will also note start/stop time of the FAST exam. 
Using the same machine, a BEFAST exam will be performed using a low mechanical 
index setting in contrast-specific imaging mode. Lumason will be injected into the 
patient’s IV for the CEUS exam by either a nurse research coordinator or one of the 
clinical staff.  The contrast will be injected using the straight port of a 3-way stopcock 
and flushed through the side port. To eliminate shear of microbubbles, contrast will not 
be injected through a clave connector. 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. If an antecubital line is placed, 2.4 
mL contrast will be given over slow IV push (2-3 seconds) and flushed with 5 ml saline; 
if only a peripheral hand IV is established, the investigator may use a 10 ml saline flush.
To examine the right side of the body: the right kidney and liver will be imaged. The 
investigator will examine the RUQ for evidence of solid organ injury, free fluid, or active 
extravasation by examining the kidney in short and long views and the liver in coronal, 
anterior, and subcostal views. 


The examiner will screen the liver during approximately the first 10-20 seconds after 
IV contrast administration to see hypoperfusion in the arterial phase or extravasation 
before scanning through all organs in the venous phase (kidney, then back to liver).  
The exam will be timed from start of saline flush after contrast and video clips will be 
saved (stored using patient study number).
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 in the LUQ. The pancreas, kidney, and spleen will be 
visualized in short and long. The exam will be timed from start of saline flush after 
contrast and video clips will be saved. If adrenal glands are visualized on either side these 
may be recorded as well. 
In general, the investigator will scan one side of body at time but may cross to the 
other side if imaging on one side is complete. Investigators will be allowed to re-dose 
contrast on either or both sides if the first examination is not clear or if there is 
inadequate time to complete the exam. Either right side or left side may be examined 
first. 
The investigator will note the presence or absence of injury to the liver, kidney, 
spleen, or pancreas, as well as the presence or absence of free fluid or active 
extravasation. If an injury to a solid organ is detected, the investigator will grade injury 
per American Association for the Surgery of Trauma (AAST) criteria.  There will be an 
attestation noting whether there was unintended disclosure of either the primary team’s 
FAST exam or CT imaging read prior to bedside interpretation of the BEFAST study. 
The investigator will note whether there were physical exam signs suggestive of injury 
that may have biased their interpretation. The investigator will note start/stop time of 
BEFAST exam.  Exams will be saved to QPATH and to the US machine; the data will 
also be archived on an encrypted USB.  QPATH will be password protected, and the 
USB will be kept in a locked file in a locked office.  The US machine will be kept in a 
locked area.     
     A study is complete if the patient tolerates the study (no severe adverse event to 
contrast, patient allows the provider to complete the scan) and if it results in images of 
adequate quality to answer the focused clinical question. 
     A serious adverse event (SAE) is defined by the FDA as any adverse drug event 
(experience) occurring at any dose that in the opinion of either the investigator or sponsor 
results in any of the following outcomes: 1) death 2) life-threatening adverse drug 
experience 3) inpatient hospitalization or prolongation of existing hospitalization (for > 
24 hours) 4) persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 5) congenital anomaly/birth defect 6) important medical 
event (IME) that may not result in death, be life threatening, or require hospitalization 
may be considered a serious adverse drug experience when, based upon medical 
judgment, it may jeopardize the patient or subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition.
For the FAST exam, the focused clinical question is whether there is free fluid in 
the abdomen or fluid in the pericardium.  The following views should be obtained to meet 
minimum requirements: RUQ, LUQ, suprapubic, and subxiphoid views with adequate 
visualization of Morison’s pouch, inferior pole of right kidney/liver tip, area under the 
diaphragm on the LUQ side, pelvic views in transverse and sagittal. If an adequate 


subxiphoid view is not possible, a parasternal long view may be substituted. For the 
BEFAST exam the focused clinical question is if there is solid organ injury to the liver, 
kidney, spleen, or pancreas. For the BEFAST exam the liver, kidney, spleen, and 
pancreas should be examined using a low mechanical index setting in contrast-specific 
imaging mode. 
     In order to determine interrater reliability of the ultrasound exams, the interpretation 
of the point-of-care EM physician (who will attest they are blind to the CT read and the 
ATLS FAST read) will be compared to the interpretations of two board-certified 
radiologists (blinded to the FAST reads and the CT read) for the presence or absence of 
solid organ injury, free fluid, or active extravasation. Injured organs will be graded per 
AAST criteria.  
7. Video clips collected for this study will be saved for future education and training 
purposes, and also used in research presentations at national conferences.
8. N/a: The study does not target a particular community.
9. Participant Selection:
Requested sample size: 267; expected refusal or withdrawal rate – conservatively we 
set at 90%. 
Inclusion Criteria: 
Age 18 and older
Clinical suspicion of intra-abdominal injury (IAI)
Presentation within 24 hours of injury
Planned CT of the abdomen/pelvis within 24 hours
Ability of patient 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 HR >120 despite initial resuscitation) 
Justification: 
We did not include pediatric population because FAST sensitivities are different in adult 
and pediatric populations.    
HD stable because unstable patients might go immediately to OR
Clinical suspicion of IAI and presentation within 24 hours because this would be the most 
clinically relevant presentation for an emergency physician using the BEFAST exam which 
is a point-of-care study in the acute presentation of possible IAI.
Planned CT because of the need for confirmatory gold standard study.


Exclusion Criteria:
We excluded penetrating abdominal injury to focus on blunt abdominal injury in isolation.
We excluded patients with known hypersensitivity reaction so that we could avoid SAE.
We excluded pregnant patients and prisoners as vulnerable populations.
We excluded patients without sufficient access because we would not be able to insert 
contrast.
Subject recruitment plan:
Initial contact will be made by the study staff (clinical research coordinator, ASSET team, 
PI, co-investigator) upon presentation of potential subjects (i.e. subjects meeting the 
inclusion criteria) in the emergency room/hospital. Study staff will obtain written informed 
consent.
Screening for eligibility:
In order to effectively screen potential patients for the study, the study personnel will ID 
subjects in the ED as appropriate through conferring with medical records, trauma logs, 
triage notes, radio reports of trauma alerts, and on-duty doctor and nurses to identify 
potential subjects. Many of the inclusion/exclusion criteria can be evaluated by a review of 
the potential subject’s medical records such as: mechanism of injury, time of injury, 
presence or absence of concurrent penetrating trauma. All female patients of childbearing 
age will be offered a serum or urine pregnancy test (standard of care for evaluation of 
female trauma patient with suspected intra-abdominal injury). A patient may exercise their 
autonomy and waive pregnancy testing (due to reasons such as prior hysterectomy, tubal 
ligation) but are still eligible for the study as long as they are informed that Lumason is a 
Category B medication which means that animal studies have failed to demonstrate a risk 
to the fetus and there are no adequate and well-controlled studies in pregnant women.  The 
patient’s refusal of pregnancy test will be documented in the medical record. No 
identifiable data will be collected from subjects during screening.  
Procedures when a subject withdraws from a study:
In the case of withdrawal from study, videos saved up to the point of withdrawal may be 
kept as outlined in the study consent form. Once linkages are destroyed it will not be 
possible to identify an individual’s video clips for destruction.
10. Informed Consent Process
A research team member will consent the patient at Grady Memorial Hospital. 
We are requesting a partial HIPAA waiver to look at identifiable patient information prior 
to consent as part of the screening process in order to see if a patient meets 
inclusion/exclusion criteria. Elements of interest include: name, medical record number, 
age, mechanism of injury, timing of injury, pregnancy status, institutionalization, vital 
signs, allergies.
We are not studying children, prisoners, pregnant women/fetuses, or patients with 
cognitive impairment.  Students and employees are not targeted groups for enrollment.


We will ensure comprehension of the informed consent information by allowing the patient 
ample time to ask questions and have the patient express understanding of the study. The 
study team will explain the purpose, risks, and potential benefits of the study and patient 
will be given the option of continuing participation or stopping.
Study consent discussion will take place in Grady Memorial Hospital.  Study staff (research 
coordinator, ASSET team, PI, or co-I) will conduct the discussion and obtain consent. We 
are not requesting a waiver of signed documentation of informed consent.
In the event that the patient is cognitively capable of consent for the study but has a physical 
impairment (such as a broken arm) that prevents them from signing the consent document, 
the research team will obtain a signature from a witness to the consent process who is not 
a member of the research team. The witness will sign the consent paperwork (their 
signature, time, and date), leaving the patient fields blank. An informed consent process 
note will also be filed to document the circumstances, who served as a witness, and the 
relationship of the witness to the patient (e.g. related or unrelated to subject). 
11. Incidental Findings
The research team will relay any findings related to injury to solid organs and 
hemoperitoneum to the primary treatment team for further management.  The FAST and 
BEFAST exams are screening exams only and not comprehensive abdominal exams; 
additional findings are not anticipated. If additional incidental findings are noted they will 
be relayed to primary treatment team for appropriate triage, referral to clinical specialists, 
and patient education as needed if the finding is clinically significant. All study patients 
will also obtain confirmatory imaging with CT study.
12. Compensation for time and effort: $25 single payment as reimbursement for parking 
expenses, time, effort.
13. Statistical Analysis:
Objective 1: To determine if contrast-enhanced, i.e. bubble-enhanced FAST (BEFAST) 
outperforms non-enhanced FAST in the evaluation of solid organ injury in 
hemodynamically stable blunt abdominal trauma patients when performed by frontline 
providers using CT as gold-standard.
Descriptive Statistics. The primary results will be described using sensitivities and 
specificities with 95% confidence intervals. Categorical variables will be described using 
frequencies and percentages. Continuous variables will be described using means and/or 
medians as appropriate.
Primary Analyses. Agreement with the CT results will be examined using a mixed-
effects/multi-level logistic regression in order to account for clustered measurements. 
Results from this regression will also be adjusted for the following covariates: 


demographics (e.g. age, sex, race), BMI, sonographer experience, contrast redosing, the 
presence of outward signs of injury.  In the event that the logistic regression fails to estimate 
properly or provides poor fit to the data and/or to show consistent results across methods, 
alternative methods will be explored: (1) P-values and confidence intervals will be 
computed using a bias-corrected and accelerated bootstrapping procedure (≥5,000 
resamples); (2) Sensitivities and specificities for BEFAST and FAST will be compared 
using McNemar’s test. 
Sample Size Calculations. Two primary issues were taken into consideration when 
calculating the required sample size: 1) statistical power, and 2) the expected rate of 
positive outcomes.
1) Power calculations were based on previous studies examining the sensitivity and 
specificity on standard and contrast-enhanced ultrasound. The results from these studies 
were meta-analyzed (fixed-effects, inverse-variance method) and indicated that (1) the 
sensitivity for CEUS (lower limit = 0.87) is greater than the sensitivity for standard 
ultrasound (upper limit = 0.68); and (2) the specificity for CEUS (0.98) is similar to the 
specificity for standard ultrasound (0.95). This analysis aimed to ensure that the present 
study has sufficient power to show improved sensitivity when using CEUS. Note that, 
because this sample size calculation uses the lower limit of the CEUS estimate and the 
upper limit of the standard ultrasound estimate, actual power will likely be greater. Given 
the small meta-analytic difference in specificities between methods, it is unlikely that 
differences in specificity will be detected. These values were used to estimate the sample 
size required to achieve 80% power using Monte Carlo simulations (10,000 samples) 
implemented in R v3.4.1. This analysis determined that the sample size would need to be 
at least 187. 
2) Using the rule of thumb 10 positive results for each predictor, we aimed to ensure that 
there will be a sufficient number of positive results for a model with two predictors (i.e. at 
least 20 positives. Thus, the current study will aim for a sample size of at least 187; 
however, data collection will not end until at least 20 CT+ patients are enrolled. 
Importantly, this stopping rule is entirely a priori and ceasing data collection will not be 
dependent on any statistical analyses, significance tests, or interim analyses. No analyses 
will be conducted until after this stopping rule is reached.
Missing Data. In the event of substantial missing data, data will be imputed using a multiple 
imputation procedure. The type of procedure and the number of imputed data sets will be 
determined by the amount of missing data and the pattern of missingness. As a sensitivity 
analysis, we will 1) assume the worst and assign a “does not agree” outcome for that patient 
and 2) assume the best and assign an “agrees” outcome for that patient. These analyses will 
describe the boundary conditions for the models described above.
Objective 2: To determine whether emergency physicians can incorporate BEFAST 
evaluation at the point-of-care in a trauma evaluation of a hemodynamically stable adult 
blunt abdominal trauma patient. 


An exam is complete if the patient tolerates the exam (no severe adverse reaction to 
contrast, patient allows the provider to complete the scan) and if it results in images of 
adequate quality to answer the focused clinical question.
Completion rates will be described as percentages with 95% confidence intervals. 
Assuming maximal variance for a binomial variable (π = 0.5), a sample size of 187-267 
(approximate) will result in 95% CIs that are no wider than ± 7.2% to 6.0%. FAST and 
BEFAST completion rates will be compared using either the multilevel/mixed effects 
logistic regression described above or McNemar’s test.
Objective 3: To determine the interrater reliability between bedside emergency physicians 
and radiologists for identifying solid organ injury with BEFAST.  
Inter-rater Reliability for the presence/absence of an injury will be evaluated using Cohen’s 
or Fleiss’ kappa as appropriate. The reliability of AAST scores will be evaluated using a 
weighted kappa statistic.
Assuming a minimal sample size of 187, the current study will have sufficient power (≥ 
80%) to detect reliability coefficients exceeding 0.23. For clinically relevant ratings, such 
as this, reliability is generally required to be high. Guidelines vary and are generally 
arbitrary; however, 0.8 and 0.9 are often used as cutoffs for “high” agreement, whereas a 
value such as 0.23 would be considered unacceptable. Thus, the current study is sufficiently 
powered to detect clinically acceptable levels of agreement. 
14. Data and Safety Monitoring and Reporting:
Monitoring the Progress and Safety of the Trial
During the screening process, patients will be excluded if they belong to vulnerable 
populations such as pediatric, pregnant, or imprisoned patients or if they have a known 
hypersensitivity to ultrasound contrast agent.     
Measures to protect participants against risk include use of a physician or certified health 
care professional (nurse practitioner, physician assistant or registered nurse) to administer 
contrast.  Confidentiality of participants will be protected by keeping data and US images 
password protected. The study will utilize a code number as the only identifier for each 
subject and the master list will be kept under lock and key with access limited to the PI 
and study coordinator. 
Site Monitoring Plan
This study will not be followed by a separate Data and Safety Monitoring Board. A 
medical monitor will be responsible for monitoring the data and for conducting safety 
reviews on a quarterly basis.  Scope of monitoring includes informed consent process, 
eligibility, adverse event reporting. 
During the review process, the monitor will evaluate whether the study should continue 
unchanged, require modification or amendment, continue or close to enrollment. A 
monitoring report will be provided to the PI within 5 days of review. PI will document 


receipt & review of the monitoring report, resolutions, and/or corrective actions to 
findings on the Site Monitoring Log; PI will notify IRB according to policies and 
procedures. 
Oversight of the progress and safety of the trial will be provided by the PI.  Adverse 
events are not anticipated, but any occurring will be documented and reported according 
to Emory IRB policies and procedures. Cumulative adverse events and study progress 
summary will be communicated to the IRB at the time of continuing review. 
A serious adverse event (SAE) is defined by the FDA as any adverse drug event 
(experience) occurring at any dose that in the opinion of either the investigator or sponsor 
results in any of the following outcomes: 1) death 2) life-threatening adverse drug 
experience 3) inpatient hospitalization or prolongation of existing hospitalization (for > 
24 hours) 4) persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 5) congenital anomaly/birth defect 6) important medical 
event (IME) that may not result in death, be life threatening, or require hospitalization 
may be considered a serious adverse drug experience when, based upon medical 
judgment, it may jeopardize the patient or subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition.
The PI will be responsible for reviewing protocol compliance, data collection and 
verification.  The PI will immediately notify IRB in the event of a serious adverse event 
according to the Emory IRB reporting requirements. Once an unanticipated event is 
recognized and reported, the event will be investigated to determine if the event 
represents an unreasonable risk to the subject so as to terminate all or part of the study. 
15. Confidentiality:
We plan to protect subjects’ privacy during the course of their participation in the study 
by de-identifying data and assigning each patient a code. The linkage between code and 
patient will be kept in secure location – locked file cabinet, locked office, accessible only 
to PI and study team members and only during the duration of active study.  Whenever 
possible, a study number, rather than the patient’s name will be used on study records. 
The patient’s name and other identifying information will not appear when the study is 
published or results presented. 
Electronic data will be secured via a secure network that is password protected. Studies 
will be backed up to encrypted USB. Hard copy will be secured in a locked office in a 
locked filing cabinet. 
All links to identifiable data will be destroyed after publication and presentation of 
research data.  De-identified video clips will be archived indefinitely (as outlined in 
consent) for education and future research.


16. References/Bibliography
1. https://emedicine.medscape.com/article/1980980-overview
2. https://www.facs.org/quality-programs/trauma/tqp/center-programs/ntdb
3. Stengel, D, Leisterer, J, Ferrada P, Ekkernkamp, A, Mutze, S, Hoenning, A. Point-of-
care ultrasonography for diagnosing thoracoabdominal injuries in patients with blunt 
trauma. Cochrane Database Syst Rev. 2018 Dec 12 (12)
4. McGahan, JP, Horton, S, Gerscovich, EO, Gillen, M, Richards, JR, Cronan, MS, Brock, 
JM, Battistella, F, Wisner, DH, and Holmes, JF. Appearance of solid organ injury with 
contrast- enhanced sonography in blunt abdominal trauma: preliminary experience. 
American Journal of Roentgenology. Sept 2006, 187 (3).
5. Rothlin, M., Naf, R. Amgwerd, M., Candinas, D., Frick, T., Trentz, O.  Ultrasound in 
Blunt Abdominal and Thoracic Trauma. The Journal of Trauma and Acute Care 
Surgery. April 1993; 34 (4).
6. Jansen, JO, Yule, SR, and Loudon, MA. Investigation of blunt abdominal trauma. BMJ. 
2008. Apr 26; 336(7650): 938–942.
7. Nishijima, DK, Simel DL, Wisner, DH, Holmes, JF. Does this patient have a blunt 
intra- abdominal injury? JAMA. 2012 Apr 11; 307(14): 1517–1527.
8. Griffey RT, Fowler KJ, Theilen A, Gutierrez A. Considerations in Imaging Among         
Emergency Department Patients With Inflammatory Bowel Disease. Ann Emerg Med. 
2017 May; 69(5): 587-599
9. Stanislaw, P.A. Stawicki. Trends in nonoperative management of traumatic injuries – 
a synopsis. Int J Crit Illn Inj Sci. 2017 Jan-Mar; 7(1): 38-57.
10. Ahmed, N. and Vernick, J. Management of liver trauma in adults. J Emerg Trauma 
Shock. 2011 Jan-Mar; 4(1): 114-119.
11. Howard, R. VOMIT (victims of modern imaging technology) – an acronym for our 
times. BMJ 2003. 326 (7401): 1273.
12. Kummer, T, Oh, L. Phelan, MB., Huang, RD, Nomura, JT, and Adhikari, SR. 
Emergency and critical applications for contrast-enhanced ultrasound. Am J Emerg 
Med. 2018 Jul; 36(7): 1287-1294.
13. Brink JA, Amis ES Jr. Image Wisely: a campaign to increase awareness about adult         
radiation protection. Radiology 2010; 257:601-2. 
14. Goske MJ, Applegate KE, Boylan J, Butler PF, Callahan MJ, Coley BD et al. The 
Image Gently Campaign: Working Together to Change Practice. American Journal of         
Roentgenology 2008; 190: 273-4. 
15. Keller MW, Segal SS, Kaul S, Duling B. The behavior of sonicated albumin 
microbubbles within the microcirculation: a basis for their use during myocardial 
contrast echocardiography.  Circ Res 1989; 65: 458-67. 
16. Lusic H, Grinstaff MW. X-ray computed tomography contrast agents. Chem Rev 2013; 
113: 1641-66. 
17. Quaia E. Microbubble ultrasound contrast agents: an update. Eur Radiol 2007; 17: 
1995- 2008. 
18. Morel DR, Schweiger I, Hohn L, Terretraz J, Llull JB, Cornioley YA, et al. Human         
pharmacokinetics and safety evaluation of SonoVue, a new contrast agent for 
ultrasound imaging. Invest Radiol 2000; 35-80-5. 


19. Barr, R. How to Develop a Contrast-Enhanced Ultrasound Program. J Ultrasound Med 
Jun 2017; Vol 36 (6)
20. Miele, V, Piccolo, CL, Galluzzo, M, Ianniello, S, Sessa, B, and Trinic, M. Contrast-               
enhanced ultrasound (CEUS) in blunt abdominal trauma.  Br J Radiol 1016; 89: 
20150823
21. Lv V, Ning Y, Zhou X, Luo Y, Liang T, Nie Y, et al. Effectiveness of contrast-
enhanced ultrasound in the classification and emergency management of abdominal 
trauma. Eur Radiol 2014; 24:2640-8
22. Cokkinos DD, Antypa E, Kalogeropoulos I, Tomais D, Ismailos E, Matsiras I, et al.                 
Contrast-enhanced ultrasound performed under urgent conditions. Indications, review 
of the technique, clinical examples and limitations. Insights Imaging 2013; 4:185-98.
23. Lv F, Tang J, Luo Y, Li Z, Meng X, Zhu Z, et al. Contrast-enhanced ultrasound imaging 
of active bleeding associated with hepatic and splenic trauma. Radiol Med 2011; 116: 
1076- 1082.
24. Appis, AW, Tracy MJ, and Feinstein, SB. Update on the safety and efficacy of 
commercial ultrasound contrast agents in cardiac applications. Echo Res Pract 2015; 
Jun 1; 2(2): R55- R62.

ICF_000.pdf: 
Informed Consent Form 
 
 
TITLE: BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury in 
Hemodynamically Stable Blunt Abdominal Trauma 
 
 
NCT NUMBER: NCT05025449 
 
 
IRB APPROVAL DATE: July 19, 2023 
 


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IRB Form 06162020
You Are Being Asked to Be in a Research Study
Concise presentation of key concepts
You are being asked to be in a research study. A research study is designed to answer a 
scientific question. If you agree to be in the study you will be one of 267 people who are being 
studied at Emory. 
Why is this study being done? 
This study is being done to answer the question: Does the use of ultrasound contrast improve 
the ability of the ultrasound exam to detect injury to abdominal organs (liver, spleen, 
pancreas, kidneys)?  Ultrasound is an imaging test that, unlike CT scan, allows doctors to 
examine your organs without the use of ionizing radiation. You are being asked to be in this 
research study because you are a patient who might have suffered injury to your abdominal 
organs.
Do you have to be in the study? 
It is your decision to be part of this research study. You do not have to be in it. Your choice will 
not affect your access to medical care for your condition. Before you make your decision, you 
should take time to learn about the study.
What do I have to do if I choose to participate in this study?
If you are eligible and want to be part of the study, you will participate for 1 study visit.  The 
researchers will ask you to do the following: US exam of abdomen with and without 
ultrasound contrast. ALL of these procedures will be paid for by the study.   
How is this study going to help you? 
If you are in the study, you will be helping the researchers answer the study question: Does 
the use of ultrasound contrast improve the sensitivity of the exam for detecting injury to the 
liver, spleen, kidneys, pancreas?
What are the risks or discomforts I should know about before making a decision?  
The study will take time and may not benefit you. The contrast-enhanced ultrasound exam 
that is being tested may not work any better than regular care, and may even cause harm. All 
studies have some risks.  Some risks are relatively small, like being bored or losing time.  Some 
are more serious – for this study, these include headache, nausea, dizziness, flushing, allergic 
reactions, shortness of breath, back, kidney, or chest pain, hypertension, hypotension, loss of 
privacy, and breach of confidentiality.  A full list of expected risks, their frequency and severity 
are in the “What are the possible risks and discomforts?” section of this document.
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Alternatives to Joining This Study
Since this is not a treatment study, the alternative is not to participate.  Patients not joining 
the study will receive usual trauma care which may include a non-contrasted FAST exam 
(limited ultrasound of abdomen and chest).
Costs
You WILL NOT have to pay for any of the study procedures, in particular those that are not 
covered by your medical insurance.  The study will not pay for usual care.
There is more information in the cost section below.
What Should I Do Next?
Read this form, or have it read to you.  Make sure the study doctor or study staff explains the 
study to you. Ask questions (e.g., about exact time commitment, about unfamiliar words, 
more details on specific procedures, etc.) Make sure you understand which parts of are 
research and which are standard care that you would have even if you did not join the study.  
Take time to consider this, and talk about it with your family and friends.
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Emory University and Grady Health System 
Consent to be a Research Subject / HIPAA Authorization 
Title: BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury in Hemodynamically Stable Blunt 
Abdominal Trauma
IRB #: 00100619
Principal Investigator: Laura Oh, MD, Emory School of Medicine, Department of Emergency Medicine
Sponsor: Department of Defense
Introduction
You are being asked to be in a medical research study. This form is designed to tell you everything you need to think 
about before you decide if you want to be a part of the study.  It is entirely your choice.  If you decide to take part, you 
can change your mind later on and withdraw from the research study. The decision to join or not join the research 
study will not cause you to lose any medical benefits.  If you decide not to take part in this study, your doctor will 
continue to treat you.
Before making your decision:
•
Please carefully read this form or have it read to you
•
Please listen to the study doctor or study staff explain the study to you 
•
Please ask questions about anything that is not clear
You can take a copy of this consent form, to keep. Feel free to take your time thinking about whether you would like to 
participate. You may wish to discuss your decision with family or friends. Do not sign this consent form unless you have 
had a chance to ask questions and get answers that make sense to you.  By signing this form you will not give up any 
legal rights.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This Web site 
will not include information that can identify you. At most the Web site will include a summary of the results. You can 
search this Web site at any time.
What is the purpose of this study?
The purpose of this study is to see if using contrast (medication put through your IV) with ultrasound helps identify 
injury to your liver, kidney, spleen, or pancreas better than ultrasound that does not use contrast.  The study will take 
place at Grady Memorial Hospital. A single ED visit is the expected duration of participation. The ultrasound study itself 
will take 5-10 min and will not delay standard emergency services. We will be enrolling 267 patients. The study will use 
an ultrasound contrast agent called Lumason. Lumason is not FDA approved for the purpose it is used in the study 
(trauma evaluation), but it is FDA approved for use in other applications, such as looking at heart function and liver 
lesions in adults and looking at bladder reflux in children. 
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What will I be asked to do? 
During your emergency department stay we will do 2 ultrasound exams. Normally during a trauma evaluation for 
abdominal pain you would get one ultrasound study without contrast.  If you participate in our study we will do one 
additional ultrasound study that is estimated to take around 5-10 minutes.   We will take video clips of your liver, kidney, 
spleen, and pancreas with the ultrasound machine.   The addition of contrast to the study is for research purposes only 
although if we see an injury we will notify your treating physician.
How will contrast agent be provided? 
The contrast agent that will be administered through your IV that will be dispensed by the pharmacy and delivered to 
the principal investigator or study team member.  Ultrasound contrast is delivered through the use of microbubbles that 
contain the contrast agent. Unlike CT contrast, ultrasound contrast does not harm kidneys. People who are allergic to CT 
contrast are not necessarily allergic to ultrasound contrast. US contrast does not expose you to radiation. The principal 
investigator or health care providers on his/her research team will provide the medicine to you.  If you have questions 
about the medicine, you should ask the principal investigator or study nurse.  
Who owns my study information and samples?
If you join this study, you will be donating your samples and study information.  You will not receive any compensation if 
your samples or information are used to make a new product. If you withdraw from the study, data and samples that 
were already collected may be still be used for this study.
What are the possible risks and discomforts?
There may be side effects from the study drug or procedures that are not known at this time.  
Ultrasound Procedure Risks:
Ultrasound risks are minimal – there is no use of ionizing radiation.
The most common risks and discomforts expected in this study from use of ultrasound are:
Discomfort from cold ultrasound gel.
Contrast Risk
The use of ultrasound contrast also has minimal risk based on previously published research.
The less common risks and discomforts expected in this study are: (6 patients out of 30,222)
Headache, nausea, dizziness, flushing, back pain, kidney pain, chest pain, shortness of breath, hypertension, mild allergic 
reactions
Rare but possible risks include: hypersensitivity to contrast resulting in low blood pressure (2 patients out of 30,222 
patients) 
If you are a woman: to protect against possible side effects of the study drug, women who are pregnant or nursing a 
child may not take part in this study. Pregnant women will be taken out of the study.
If you are a man: the effect of the study drug on sperm is not known.  
It is possible that the researchers will learn something new during the study about the risks of being in it.  If this 
happens, they will tell you about it. Then you can decide if you want to continue to be in this study or not.  You may be 
asked to sign a new consent form that includes the new information if you decide to stay in the study.
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Will I benefit directly from the study? 
This study is not designed to benefit you directly.  This study is designed to learn more about the ability of ultrasound to 
pick up injuries to liver, kidney, spleen, pancreas, when enhanced with the use of contrast. The study results may be 
used to help others in the future.
Will I be compensated for my time and effort?
You will get $25.00 gift card for your participation in the study, to compensate you for your time and effort whether or 
not the study is completed. The study will not pay for usual care. 
What are my other options?
If you decide not to enter this study, there is care available to you outside of this research study.  You will get evaluated 
by the emergency medicine team who may order labs or imaging as needed.  You do not have to be in this study to be 
treated for abdominal trauma.
How will you protect my private information that you collect in this study?
Whenever possible, a study number, rather than your name, will be used on study records.  Your name and other 
identifying information will not appear when we present or publish the study results.
Study records can be opened by court order.  They also may be provided in response to a subpoena or a request for the 
production of documents. 
Storing and Sharing your Information
De-identified data from this study (data that has been stripped of all information that can identify you) may be placed 
into public databases where, in addition to having no direct identifiers, researchers will need to sign data use 
agreements before accessing the data. We will remove or code any personal information that could identify you before 
your information is shared. This will ensure that, by current scientific standards and known methods, it is extremely 
unlikely that anyone would be able to identify you from the information we share. Despite these measures, we cannot 
guarantee anonymity of your personal data.  Study subjects are not able to request destruction of images at a later date 
once they have been de-identified. 
Your data from this study may be useful for other research being done by investigators at Emory or elsewhere. To help 
further science, we may provide your deidentified data and/or specimens to other researchers. If we do, we will not 
include any information that could identify you. If your data or specimens are labeled with your study ID, we will not 
allow the other investigators to link that ID to your identifiable information.
In general, we will not give you any individual results from the study of the samples you give us. If we find something of 
urgent medical importance to you, we will inform you, although we expect that this will be a very rare occurrence.
Medical Record
If you have been an Emory and Grady Health System patient before, then you already have an Emory and Grady Health 
System medical record.  If you have never been an Emory and Grady Health System patient, you do not have one.   An 
Emory and Grady Health System medical record will be made for you if an Emory and Grady Health System provider or 
facility gives you any services or procedures for this study.  
Copies of the consent form/HIPAA authorization that you sign will be put in any Emory and Grady Health System medical 
record you have now or any time during the study.  
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The results of some study tests and procedures will be used only for research purposes and will not be placed in your 
medical record.  For this study, those items include:  results of your contrast-enhanced ultrasound exam.
Tests and procedures done at non-Emory and Grady Health System places may not become part of your Emory and 
Grady Health System medical record. Also, if you decide to be in this study, it is up to you to let your other health 
providers know. 
In Case of Injury
If you believe you have become ill or injured from this research, you should contact Dr. Laura Oh at telephone number 
. You should also let any health care provider who treats you know that you are in a research study.  
If you get ill or injured from being in the study, Emory and Grady Health System will help you to get medical treatment. 
Neither Emory, Grady Health System nor the sponsor will pay for your medical treatment.  Your insurer will be billed for 
your treatment costs.  If you do not have insurance, or if your insurance does not pay, then you will have to pay these 
costs.   
Emory, Grady Health System and the sponsor have not, however, set aside any money to pay you if you are injured as a 
result of being in this study or to pay for this medical treatment. For Emory and Grady Health System, the only exception 
is if it is proven that your injury or illness is directly caused by the negligence of an Emory and Grady Health System 
employee. “Negligence” is the failure to follow a standard duty of care. You do not give up any legal rights you may have 
by being in this study, including any right to bring a claim for negligence. 
GHS Disclaimer
We will give you emergency care if you are injured by this research. However, Grady Health System and Emory have not 
set aside funds to pay for this care or to compensate you if a mishap occurs. If you believe you have been injured by this 
research, you should contact Dr. Laura Oh (Phone: 
) 
We will treat you in the emergency department and admit or refer for followup to a primary care team or appropriate 
specialty clinic as needed. 
Costs
There will be no costs to you for participating in this study, other than basic expenses like transportation. You will not be 
charged for any of the research activities. If the study procedures result in any medical complications that would not fall 
under “injury” as discussed above, the cost of treatment for those complications may be charged to you or your 
insurance.  
Withdrawal from the Study
You have the right to leave a study at any time without penalty.  If you wish to leave the study, please contact Dr. Laura 
Oh at 
  
The researchers also have the right to stop your participation in this study without your consent for any reason, especially if 
they believe it is in your best interest or if you were to object to any future changes that may be made in the study plan.  
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Authorization to Use and Disclose Protected Health Information
The privacy of your health information is important to us.  We call your health information that identifies you, your 
“protected health information” or “PHI.”  To protect your PHI, we will follow federal and state privacy laws, including the 
Health Insurance Portability and Accountability Act and regulations (HIPAA).  We refer to all of these laws as the “Privacy 
Rules.”  Here we let you know how we will use and disclose your PHI for the study.
PHI that Will be Used/Disclosed:  
The PHI that we will use or share for the main research study includes:
•
Medical information about you including your medical history and present/past medications.
•
Results of exams, procedures and tests you have before and during the study.
•
Laboratory test results.
Purposes for Which Your PHI Will be Used/Disclosed:
We will use and share your PHI for the conduct and oversight of the research study.  We will use and share your 
PHI to provide you with study related treatment and for payment for such treatment.  We will also use and 
share your PHI to conduct normal business operations.  We may share your PHI with other people and places 
that help us conduct or carry out the study, such as laboratories, data management centers, data monitors, 
contract research organizations, Institutional Review Boards (IRBs) and other study sites. If you leave the study, 
we may use your PHI to determine your health, vital status or contact information. We will use and disclose your 
PHI for the administration and payment of any costs relating to subject injury from the study.  
Use and Disclosure of Your Information That is Required by Law:  
We will use and disclose your PHI when we are required to do so by law. This includes laws that require us to 
report child abuse or abuse of elderly or disabled adults. We will also comply with legal requests or orders that 
require us to disclose your PHI. These include subpoenas or court orders.  
Authorization to Use PHI is Required to Participate:
By signing this form, you give us permission to use and share your PHI as described in this document. You do not 
have to sign this form to authorize the use and disclosure of your PHI.  If you do not sign this form, then you may 
not participate in the research study or receive research-related treatment.  You may still receive non-research 
related treatment.  
People Who will Use/Disclose Your PHI:
The following people and groups will use and disclose your PHI in connection with the research study:
•
The Principal Investigator and the research staff will use and disclose your PHI to conduct the study.
•
Emory and Grady Health System may use and disclose your PHI to get payment for study related 
treatment and to run normal business operations. 
•
The following people and groups will use your PHI to make sure the research is done correctly and 
safely:
o
Emory and Grady Health System offices that are part of the Human Research Participant 
Protection Program and those that are involved in study administration and billing.  These 
include the Emory IRB, the Grady Research Oversight Committee, the Emory Research and 
Healthcare Compliance Offices, and the Emory Office for Clinical Research. 
o
Government agencies that regulate the research including: Food and Drug Administration
o
Public health agencies.
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o
Research monitors and reviewer.
o
Accreditation agencies.
•
Sometimes a Principal Investigator or other researcher moves to a different institution. If this happens, 
your PHI may be shared with that new institution and their oversight offices. PHI will be shared securely 
and under a legal agreement to ensure it continues to be used under the terms of this consent and 
HIPAA authorization.
•
This is a Department of Defense (DoD) funded project. Please be advised that the DoD may also have 
access to your records.
Expiration of Your Authorization
Your PHI will be used until this research study ends. At that time, we will delete identifiers linking your participation to 
study data.
Revoking Your Authorization
If you sign this form, at any time later you may revoke (take back) your permission to use your information.  If you want 
to do this, you must contact the study team at: 
At that point, the researchers would not collect any more of your PHI.  But they may use or disclose the information you 
already gave them so they can follow the law, protect your safety, or make sure that the study was done properly and 
the data is correct.  If you revoke your authorization you will not be able to stay in the study. 
Other Items You Should Know about Your Privacy
Not all people and entities are covered by the Privacy Rules.  HIPAA only applies to health care providers, health care 
payers, and health care clearinghouses.  If we disclose your information to people who are not covered by the Privacy 
Rules, including HIPAA, then your information won’t be protected by the Privacy Rules.  People who do not have to 
follow the Privacy rules can use or disclose your information with others without your permission if they are allowed to 
do so by the laws that cover them. 
To maintain the integrity of this research study, you generally will not have access to your PHI related to this research 
until the study is complete.  When the study ends, and at your request, you generally will have access to your PHI that 
we maintain in a designated record set.  A designated record set is data that includes medical information or billing 
records that your health care providers use to make decisions about you. If it is necessary for your health care, your 
health information will be provided to your doctor. 
We may remove identifying information from your PHI.  Once we do this, the remaining information will not be subject 
to the Privacy Rules.  Information without identifiers may be used or disclosed with other people or organizations for 
purposes besides this study.  
Contact Information
Contact Laura Oh at 
•
if you have any questions about this study or your part in it,  
•
if you feel you have had a research-related injury or a bad reaction to the study drug, or
•
if you have questions, concerns or complaints about the research
Contact the Emory University Institutional Review Board at 404-712-0720 or 877-503-9797 or irb@emory.edu:
•
if you have questions about your rights as a research participant.
•
if you have questions, concerns or complaints about the research.
IRB Approved
7/19/2023


Page 9 of 10
Version Date: 1/14/2022
IRB Form 06162020
•
You may also let the IRB know about your experience as a research participant through our Research Participant 
Survey at http://www.surveymonkey.com/s/6ZDMW75.
Patient Rights
If you are a patient receiving care from the Grady Health System and you have a question about your rights, you may contact 
the Office of Research Administration at research@gmh.edu.
IRB Approved
7/19/2023


Page 10 of 10
Version Date: 1/14/2022
IRB Form 06162020
Consent and Authorization
TO BE FILLED OUT BY SUBJECT ONLY
Please print your name, sign, and date below if you agree to be in this research study. By signing this consent and 
authorization form, you will not give up any of your legal rights. We will give you a copy of the signed form to keep.
Name of Subject 
Signature of Subject (18 or older and able to consent)
Date              Time
TO BE FILLED OUT BY WITNESS IN THE EVENT PATIENT IS NOT PHYSICALLY ABLE TO SIGN
Please print your name, sign, and date below if you witnessed the patient consenting to the research study. By signing 
this consent and authorization form, you will not give up any of your legal rights. We will give you a copy of the signed form 
to keep. Please do not fill in any of the subject’s fields above.
Name of Witness
Relationship to Patient (e.g. spouse, friend, nurse)
Signature of Witness (18 or older and able to consent)
Date              Time
TO BE FILLED OUT BY STUDY TEAM ONLY
__________________________________________________________
Name of Person Conducting Informed Consent Discussion
Signature of Person Conducting Informed Consent Discussion
Date              Time
IRB00100619
IRB Approved
7/19/2023