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Blood Substitute Trauma Trial
Why is this study being conducted?
To
evaluate the life-saving potential of PolyHeme®,
(blood substitute), when given to severely injured patients
and bleeding patients, starting at the scene of injury
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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
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What
is the design of this study?
Patients
in “hemorrhagic shock” will begin to receive
either the standard of care (salt water) (control) or
the blood substitute (investigational treatment) at
the scene of injury or during transport to the hospital
(in an ambulance or helicopter). In the hospital, patients
in the control group will receive salt water for hydration
and blood, if necessary, to boost oxygen levels. Unlimited
doses of each are allowed.
Patients
in the experimental group will receive salt water for
hydration and the blood substitute to boost oxygen levels.
The maximum dose of the blood substitute will be 6 units
during the first 12 hours. Blood will be used thereafter,
as needed.
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What
is hemorrhagic shock?
“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
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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.
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What
is the current standard of care? How are trauma patients
usually treated?
They
are given saline solution (salt water) at the scene of
injury or in the ambulance. When they arrive at the hospital,
they are given blood after typing and cross-matching is
accomplished.
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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
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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
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What
is PolyHeme®?
PolyHeme®
is an oxygen-carrying blood substitute made from human
blood; requires no cross-matching, therefore it is immediately
available and compatible with all blood types; and is
highly purified to reduce the risk of viral disease
transmission. It has an extended shelf-life of over
12 months.
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Is
the blood substitute safe?
In
one earlier study where patients received PolyHeme during
a complex surgery, there was an increased number of
heart attacks noted. Other past studies in trauma patients
did not show an unexpected number of heart attacks in
patients who received Polyheme.
Past
studies have shown that the blood substitute carries
as much oxygen as blood, has not caused organ damage,
has kept people alive who have lost all of their own
blood, and can be infused up to two times a person’s
entire blood volume.
There
can be unknown risks associated with PolyHeme®.
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Has
PolyHeme® been tested on humans before?
There
have been 5 human clinical trials of the blood substitute.
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How
many patients have been treated with the blood substitute?
Over 300 patients have been treated, including patients
in a hospital-based trauma trial.
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What happened to
them?
In
the Phase II hospital trauma trial, the blood substitute
significantly increased survival compared to historical
controls in patients where blood was not available.
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What
is an exception from informed consent?
Regulations
established by the Federal government, (21 Code of Federal
Regulations 50.24) specify the conditions under which
an exception from informed consent can be granted. This
exception allows potentially life-saving research to
be carried out in emergency situations, even when consent
is not possible because of the nature and extent of
the patient’s injuries.
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Why
was such an exception granted in connection with this
study?
In
accordance with the regulations, an exception can be
granted if 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 the particular
intervention.
Participating
in the study has 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 blood
substitute 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 the necessary treatment/care
of the patient.
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Who
grants such exceptions?
The
U.S. Food and Drug Administration (FDA) reviews qualifying
studies to determine whether they meet the conditions
specified in 21 Code of Federal Regulations 50.24. The
Institutional Review Board (IRB) associated with each
hospital approves its use locally.
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What
if patients don’t want to participate in this
study?
Patients
can withdraw from the study at any time by notifying
the investigator.
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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.
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What
are the potential benefits of participating in the study?
· The blood substitute 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.
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What
are the potential risks of participating in the study?
·
Rash
· Increased blood pressure
· Kidney or liver damage
· Transmission of hepatitis and HIV viruses
· Unforeseen happenings
·
In one earlier study where patients received PolyHeme
during a complex surgery, there was an increased number
of heart attacks noted. Other past studies in trauma
patients did not show an unexpected number of heart
attacks in patients who received Polyheme.
There
can be unknown risks associated with PolyHeme®.
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How
much will it cost patients to participate?
There
is no charge to the patient to participate in this study.
The study sponsor will pay the costs of certain laboratory
tests that are required.
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Will
patients get paid to participate?
No,
patients will not be paid to participate in this study.
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Who
is the manufacturer of the blood substitute?
Northfield
Laboratories Inc., Evanston, Ill. For more information,
visit www.northfieldlabs.com
(The
source of this information is Northfield Laboratories.)
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Related
links:
PolyHeme®
Blood Substitute Trauma Trial
Community
meetings
Frequently
asked questions
Loyola
news release
PolyHeme®
study survey
Feedback
form
Regulatory
Exception for Studies Conducted in Emergency Settings
Complete
Regulation for the Protection of Human Research Subjects
(Section 50.24)
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