questions and answers
polyheme® trauma
trial
- Why is this study being conducted?
- What is the title of the study?
- What is the study design?
- What is hemorrhagic shock?
- Why is there a need for improvement in treatment?
- How are trauma patients usually treated?
- Who would be eligible for the study?
- Who would be excluded from the study?
- What is PolyHeme?
- Is PolyHeme safe?
- Has PolyHeme been tested on humans before? What happened to them?
- What is an exception to informed consent?
- Why would such an exception be granted for this study?
- Who grants such exceptions?
- What if patients don't want to participate in such studies?
- Will patients still receive treatment is
they
don't want to participate in the study?
- What are the benefits of participating?
- What are the risks of participating?
- Will it cost patients to participate in the study?
- Will study participants be paid for participating?
- Who makes PolyHeme?
Why is this study being conducted?
To evaluate the safety and effectiveness of PolyHeme® when given to severely injured patients and bleeding patients, starting at the scene of injury. It is hoped that infusing PolyHeme® will reduce the mortality rates in comparison to salt water infusion when started at the scene of injury and in comparison to blood during the first 12 hours in the hospital.
What is the title of this study?
A Phase III, Randomized, Controlled,
Open-Label,
Multicenter, Parallel Group Study Using Provisions for Exception from
Informed
Consent Requirements Designed to Evaluate the Safety and Efficacy of
Poly
SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated)
PolyHeme®]
When Used to Treat Patients in Hemorrhagic Shock Following Traumatic
Injuries
Beginning in the Prehospital Setting
What is the
design
of this study?
Patients in
“hemorrhagic
shock” (a condition of dangerously low blood pressure due to blood
loss)
will begin to receive either the standard of care (salt water)
(control)
or PolyHeme (investigational treatment). Treatment
would begin before arrival at the hospital, either at the scene of the
injury
or in the ambulance, and continue during a 12 hour post-injury period
in
the hospital.
In the hospital,
patients
in the control group will receive salt water for hydration and blood if
necessary
to boosts oxygen levels. Unlimited
doses of each
are allowed.
Patients in the
investigational
group will receive salt water for hydration and PolyHeme® to boost
oxygen
levels. The maximum dose of PolyHeme will
be 6 units during first 12 hours. Blood will be used thereafter.
Hemorrhagic means the patient
has
experienced massive blood loss
Shock is a life-threatening
condition
that might include:
·
Dangerously low blood pressure
·
Internal
organs don’t receive
enough
oxygen and have difficulty functioning
·
Might lead to death
Why is there
a
need for improvement in the way trauma patients are treated now?
Trauma is the leading cause of death
among
Americans under the age of 45.
What is
the
current standard of care? How are trauma
patients
usually treated?
They are given saline solution (salt
water)
at the scene or in the ambulance. When
they arrive
at the hospital, they are given blood after typing and cross-matching
is
accomplished.
Who would be
eligible for the study?
Patients who have lost a large amount
of
blood and are in shock
Patients who are at least 18 years old
Patients who have sustained severe
injuries
Who would be
excluded from the study?
Women who are obviously pregnant
Patients with severe brain injuries
Patients who require CPR to maintain
their
heartbeat
Patients with “unsurvivable” injuries
Patients who are known to object to
blood
transfusions
Patients who are known to refuse
resuscitation
PolyHeme® is an oxygen-carrying blood
substitute
made from human blood.
PolyHeme® requires no cross-matching,
therefore
it is immediately available and compatible with all blood types. PolyHeme® is highly purified to reduce the
risk of viral
disease transmission. It has an extended
shelf-life
of over 12 months.
In clinical trials to date, PolyHeme®
has
demonstrated no “clinically relevant” adverse effects. That is, they
didn’t
impact the patient’s safety or recovery.
Past studies have shown that PolyHeme®
carries
as much oxygen as blood, has not caused organ damage, keeps people
alive
who have lost all of their own blood, and can be infused up to two
times
a person’s entire blood volume.
Has PolyHeme®
been tested
on humans before?
There have been 5 human clinical
trials
of PolyHeme®.
How many patients have been treated
with
PolyHeme®?
Over 300
patients
have been treated, including patients in a hospital-based trauma trial.
What happened to them?
In the Phase II hospital trauma trial,
PolyHeme®
significantly increased survival compared with historical controls.
What is an
exception from informed consent?
Regulations established by the Federal
government,
(21 Code of Federal Regulations 50.24) specifies the conditions under
which
an exception from informed consent so that in emergency situations,
research
can be carried out even when consent is not possible because of the
nature
and extent of the patient’s injuries.
Why would
such
an exception be granted in connection with this study?
Patients are in a life-threatening
situation,
available treatments are unproven or unsatisfactory, and the collection
of
valid scientific evidence is necessary to determine the safety and
effectiveness
of particular investigational interventions.
Participating in the study may have
the
prospect of direct benefit to the enrolled patients because:
·
Patients are in a
life-threatening
situation that necessitates intervention
·
Previous studies demonstrate
the
potential to provide a direct benefit to enrolled patients
·
Risks associated with the use
of
the PolyHeme® are reasonable in relation
to what is
known about the patients’ medical condition, the risks and benefits of
standard
therapy, and the risks and benefits of the proposed intervention
It is expected that patients will be
unable
to give informed consent because the extent of their injuries and the
fact
that they are in shock.
There won’t be time to find and ask
for
consent from the patient’s legally authorized representative (LAR)
before
beginning treatment.
The U.S. Food and Drug Administration
(FDA)
under regulations called 21 Code of Federal Regulations 50.24 specifies
the
conditions under which an exception from informed consent may be
obtained. The Institutional Review Board
(IRB) associated with each
hospital approves its use locally.
What if
patients don’t
want to participate in this study?
Patients can withdraw from the study
at
any time by notifying the investigator.
Will patients
still receive treatment if they don’t want to participate in the study?
Patients will still receive the
standard
of care if they decline to participate in this study.
What are the
potential
benefits of participating in the study?
PolyHeme® may increase the likelihood
of
survival after traumatic injury.
Patients might avoid the risks of
blood
transfusion.
Patients might avoid a reduction in
the
function of internal organs that sometimes follows blood transfusion.
This study may help patients in the
future.
What are the
potential
risks of participating in the study?
Rash
Temporary, non-life-threatening
increase
in blood pressure
Transmission of hepatitis and HIV
viruses
Kidney or liver damage with some
resulting
loss of kidney or liver function has occurred in patients who received
other
free hemoglobin products, but so far has not been found in patients who
received
PolyHeme®, however there is a potential risk that this may occur with
PolyHeme® also.
Unforeseen happenings
How much will it
cost patients to participate?
There is no charge to the patient to
participate
in this study. The costs of certain
laboratory tests
that are required will be paid by the study sponsor.
Will patients get
paid to participate?
No, patients will not be paid to
participate
in this study.
Who is the
manufacturer
of PolyHeme®?
Northfield
Laboratories Inc., Evanston, IL.