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Stanford RAMPART Quelling electrical
Seizure Study
A mother holds her child’s
shoulder helplessly as he shakes
uncontrollably on the grass. The
child is in Status Epilepticus—his brain’s
neurons are generating a storm of electrical
signals, causing a prolonged seizure that
will not stop without medical intervention.
The ambulance arrives, and the paramedics
administer medicine that quells the seizure.
Although long-lasting seizures are often
fatal, this child’s life is saved.
Seizures arise from disturbances to the
electrical connectivity or activity of the
brain, which arise from a variety of factors
including epilepsy, drugs, tumors, stroke,
and injury. Regardless of the cause, the
shorter a seizure lasts, the better a person’s
chances for recovery. “You want to stop
a seizure as soon as you can,” says James
Quinn, MD, Associate Professor and
Research Director in Emergency Medicine
at Stanford Medical School. “Paramedics
now stop them with medications in the
field, but there’s a big variation in practice
about what medications to use.”
The scene of the mother and child
plays on a video on a Stanford
Medical School seizure
treatment research website. The
three-year seizure treatment
study— RAMPART, or Rapid
Anticonvulsant Medication
Prior to Arrival Trial—seeks to
determine whether injection
or an IV line is a more
effective means
Credit: sxc.hu
of administering
medication to stop
seizures. What is
interesting is the video
is an advertisement for
the study, which will take
place in seventeen academic
medical centers including
Stanford. Quinn and colleagues
12 www.stanfordscientific.org
storms of the mind
without active
consent
across the country are on schedule to launch
the study in the beginning of 2009, and the
public declaration is necessary because of a
prickly point. The patients who participate in
the study will not be conscious to give their
informed consent, or to object.
This type of research is under the category
EFIC, a medical equivalent of Code Red to
denote emergency medicine research in the
extreme cases of life-threatening situations:
Exception from Informed Consent. This
is Stanford’s first EFIC study. What this
means, then, is that Stanford exhibits public
discussions of research so that the subject
community understands the study, and
perhaps more importantly, is given the
opportunity to refuse to participate.
The Facts
With funding from the National Institute
of Health, or NIH, the study will be part of
the Neurological Emergencies Treatment
Trial Network, or NETT, which consists
of seventeen academic medical centers,
including Stanford and UCSF. As William G.
Barsan, MD, of University of Michigan said
in the online video for the RAMPART study,
“Research in an ambulance or in the ER is
hard to do, so as a result, we often don’t
know the best ways to treat patients during
the first few critical minutes and hours after
an emergency. “ In the particular case of
seizure treatment, paramedics have the right
medicines. What they do not know is the
best way of administering them.
There are two primary methods, both
of which are used by paramedics in the
field, and doctors in the hospital. The
first administers Lorezepam directly into
a vein through an IV. The mechanics of
medicine flow in the blood stream enable
fast absorption and a quick response, but
starting an IV in a person who is seizing
is difficult. The medic must hold the
seizing patient steady while he applies a
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tourniquet, a compressing device such as a

rubber band, to engorge veins and identify
Community Discussion
one suitable for injection. He must then
of the Study Lorezepam is directly
The controversial point of the study is injected into the blood
carefully insert the IV needle into the vein
that by the EFIC procedure, any patient stream to fight seizures.
while the patient’s body, and all this while
in status epilepticus within one of the The downside, is that
the patient’s body convulses violently.
medical centers performing the study is the drug must be
This necessary set up time often delays
automatically registered for the study. In injected while the
treatment.
other words, for the sake of science, consent person is moving
is implied. erratically.
The second method is to give Midazolam as
a shot into a muscle using an auto-injector,
Before sci-fi visions of maniacal doctors
similar to the Epi-pen used for patients with
flash before you, rest assured that many
severe allergies. While this administration
steps were taken to ensure a study like this
method is faster, the medicine’s entry
is well understood by the community. First,
point prevents it from stopping the seizure
Stanford formed community focus groups
quickly, as the medicine does not directly
in which the study was discussed and
enter the bloodstream.
responses measured. According to Dr. Quinn, it: sx
c.hu
Cr e d
87-89% of people strongly agreed with the
In the study, half the patients will receive
basis of the study, which allowed the study
Lorezepam through an IV and a placebo
to proceed to larger scale promotion.
shot, and the converse—Midazolam
trough the shot and a placebo IV—will be
While this reaction is very favorable, the
true for the other half of patients. It will
fundamental controversy of the consent
be a double-blind experiment, and thus
is that people must actively decline
neither the patients nor the paramedics
to be in the study, rather than actively
will know which source provides the actual
provide consent. Opposed members of
medicine, eliminating a potential source of
the community must contact Stanford
psychological interference.
Medical Center to receive a medic alert tag
specifically declining participation in the
An important point is that both Lorezepam
study. In order to spread awareness of the
and Midazolam are used by paramedics as
study, public discussion of the study was
standard procedures for treating patients in
broadcast on Stanford TV and news shows
status epilepticus. Both administrations have
as well as the Dr. Dean Edell radio program.
equivalent risks—since seizure medications
The Stanford community has been strongly
are designed to reduce hyper mental
activity, common side effects include
favorable to the study, and so the study is Humans are very
set for trials at the start of 2009.
sedation and shortened breathing.
unlike lab equipment
Ultimately, the study will determine not only The Ethics of the Study and testing modules.
which method stops seizures fastest, but While the science of the double-blind test
also which yields less serious side effects. is sound, the heart of the matter lies with
the ethics: is it right that patients be pulled
A doctor simply does
Today, the better procedure for treating a
prolonged seizure is unknown, and after the into the study without explicit consent? Why not experiment with a
study, it will not be—a fact with significant must the patients be active about refusing
implications for the standardization of the study, rather than active about being in life.
medicine practice and for countless lives. it?

volume VIII 13
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One may take a step back and look upon
medicine with a larger scale perspective
u to find an answer. When a patient arrives
c.h
sx unconscious in the ER, doctors act on
it:
ed
Cr the assumption that the patients want
the doctors to do their best to save the
patients’ lives. They treat them as best
they can though do not have consent. But
as a doctor says on the RAMPART video,
“Sometimes we don’t know for sure what
is best. Some treatments are truly tested,
and some are used because they might
be good.” Subtle and silent is the fact that
doctors do not always know what will work
well. Their actions, grounded in concern
and compassion for the patient’s life, stem
from underlying science, which requires
experiments—experiments that are not
easy to do when it comes to human lives.
Humans are very unlike lab equipment and
testing modules. A doctor simply does not
experiment with a life.
The RAMPART study functions as EFIC
because it does not present any additional
risk to the patient, and, as Dr Quinn said,
“there’s just no other way to do this kind of
research.” He concedes, “This sort of study is
obviously a huge burden for ethical reasons.
As a doctor, there’s nothing more important
than the health and rights of the patient.”
Medicine is at an interesting intersection of
science and more compassionate service.
Humans are very In the perspective of science, the body is
a dynamic experiment in action—provide
unlike lab equipment an input, measure an output. From the
and testing modules. perspective of a doctor helping a fellow
human being, the body is the seat of the
A doctor simply does person’s soul, and no life can be treated
as an expendable test subject. The doctor
not experiment with a is unlike the scientist who cracks open
the body of a system to understand how
life. it works and leaves a trail of these test
14 www.stanfordscientific.org
carcasses behind him as he pushes forward
on his path to greater knowledge. While the
scientist must be a cool, objective observer
who watches as his inserted chemical brings
poisonous death to the bacteria strain or as
the over-amplified signal causes black smoke
to emanate from a circuit board—the doctor
looks upon a patient with understanding of
both the mechanics and biology of the body
and the emotion of his being.
The human condition complicates the
Credit: sxc.hu
scientific method, as a doctor from the
RAMPART website points out, “It is difficult to
do research in emergency medicine because
of the conditions. Because of that, doctors
don’t have scientific backing for emergency
procedures enacted in the crucial minutes
immediately after an accident.”
However, there is no denying that the power
of medicine is the power of science. For a
relevant illustration, before 2001, paramedics
were not even allowed to administer drugs
to seizing patients. The monumental PHTSE
study of the late 90’s, also EFIC, determined
that administration of anticonvulsant
medication was an effective and safe
treatment for seizing patients. Because of
that EFIC study, many lives have been saved.
The RAMPART study will change the way all
future seizing patients will be treated. That
is what patients are giving with their implied
consent. What the seizure study presents
is an example of how science and human
compassion can work together to change
lives.
To Learn More
For more information, including a video
and a survey, please visit www.med.
stanford.edu/survey/rampart