UMD BOOST 3 Trial Community Feedback

What are the benefits?
Because we do not know which treatment is
best for treating TBI, a person enrolled in the
study may benefit from being placed in one
study group over the other. Based on the
information we get from this study, people
who have a TBI in the future may benefit from
what is learned from this study.
What are the risks?
The different treatment strategies may affect:
● Risk of pneumonia or lung injury
● Severe infection in the blood or brain
Brain probes may involve risks of
● Bleeding or infection
Risks of participating in research include:
● Breaches of confidentiality

What is BOOST3?

BOOST3 is a research study to learn if either
of two strategies for monitoring and treating
patients with TBI in the intensive care unit
(ICU) is more likely to help them get better.
Both of these alternative strategies are used
in standard care. It is unknown if one is more
effective than the other. In one strategy
doctors concentrate only on preventing high
ICP (intracranial pressure) caused by a
swollen brain. In the other strategy doctors
try to prevent high ICP, and also try to prevent
low PbtO2 (brain oxygen). It is unknown if
measuring and treating low brain oxygen is
more effective, less effective, or the same as
monitoring and treating high brain pressure
alone. The results of this study will help
doctors discover if one of these methods is
more safe and effective.

Meet the TEAM

Principle Investigators:
Gary Schwartzbauer M.D., Ph.D.

"An Assistant Professor of Neurosurgery and Surgical Critical Care in the Program in Trauma at the University of Maryland School of Medicine, Dr. Schwartzbauer received his B.S. in Biochemistry and Biophysics, and Ph.D. in Molecular, Cellular, and Developmental Biology both from the University of Pittsburgh. He graduated as co-valedictorian and president of the AOA national medical honor society from the University of Maryland School of Medicine, and completed his neurosurgical residency at Maryland as well.

Dr. Schwartzbauer became the first neurosurgeon to complete a Surgical Critical Care Fellowship at R Adams Cowley Shock Trauma Center, where he also obtained additional fellowship training in orthopedic spine surgery. He specializes in the treatment of traumatic and degenerative spine disease, traumatic brain injury, and brain tumors.

Wendy Chang M.D.
"Dr. Chang is an assistant professor in the Department of Emergency Medicine and Program in Trauma at the University of Maryland School of Medicine. She completed an emergency medicine residency at University of Cincinnati followed by a neurocritical care fellowship at Johns Hopkins University. She has published and lectured internationally on the topics of traumatic brain injury, subarachnoid hemorrhage, and other neurological emergencies."

What is EFIC?

Exception from informed consent (EFIC) for
emergency research refers to a special set of
rules used by the US government to regulate
studies when research participants cannot tell
researchers their desires in a medical
emergency. These special rules allow
research studies in certain emergency
situations to be conducted without consent.
EFIC can only be used when:
● The person’s life is at risk, AND,
● The best treatment is not known, AND
● The study might help the person, AND
● It is not possible to get permission:
o from the person because of his or her
medical condition nor
o from the person’s representative because
there is a very short amount of time
required to treat the medical problem, or the
representative is not available.

Thank you University of Maryland Essentials: Nurses, Doctors, RT, technologist,pharmacy, research teams, housekeeping, food services, guest services, and security!

Who will be included?

● People who are 14 years or older with a
● Blunt closed head injury, with
● Severe brain injury, and
● Can start the study immediately following
brain monitor placement.
People who meet the entry criteria will be
randomly entered, like flipping a coin, into
one of the two study groups:
● Those that get medical care based on
monitoring of pressure in the brain
(intracranial pressure or ICP) alone.
● Those who get medical care based on both
ICP and the amount of oxygen in the brain
(brain tissue oxygen or PbtO2).

How is enrollment in BOOST3
different from other studies?

Normally, researchers get permission
(consent) before a person can be included in
a study. A person with a severe TBI will not
be able to give consent at the time of injury.
Since TBI must be treated quickly, there
might not be enough time to locate and talk to
the person’s family or legal representative
about the study. When consent is not
possible, a person might be enrolled in this
study without consent. This is called
“Exception from Informed Consent” (EFIC).
Once the family or legal representative is
located, they will be asked whether they want
the participant to continue in the study.

How can I share my opinions
about this study?
Before the study starts, meetings will be held
in the community to provide information,
answer questions, and get community
members’ thoughts and feelings about the
study. You can call the study team to
complete a one-on-one interview or survey
about the study. There will also be
information about the study in our live Facebook events

410.328.0288 Ask for Brandon or Leslie

https://www.umms.org/ummc/health-services/shock-trauma/news/anesthesiology-research

What is TBI?

Traumatic Brain Injury (TBI) is sudden
damage to the brain caused by an outside
force to the head – such as a car crash, a fall,
or something hitting the head.
● Every 15 seconds someone in the US
suffers a major TBI.
● Every five minutes someone is forever
disabled as a result of TBI.
● TBI is the leading cause of death and
disability in children and adults 1-44 years
of age.
TBI can affect a person’s ability to think and
remember things, cause problems with
balance and coordination, prevent a person
from functioning independently, cause
permanent brain damage or even death.

BMORE Healthy Expo with Dr. Chang and our research assistant, Brandon!!!

Dr.Chang is present to answer all of your questions about the BOOST3 trial! Dr. Sethuraman has joined us to represent the HOBIT trial as well.