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PolyHeme Trial to Begin Monday at Duke University Hospital

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Duke Health News 919-660-1306

DURHAM, N.C. -- After a series of delays, a clinical trial
designed to test an oxygen-carrying blood substitute in trauma
victims being transported to Duke University Hospital (DUH)
will begin on July 18, 2005. Only trauma patients being
transported to DUH by Durham Emergency Medical Services (EMS)
ambulances would potentially be enrolled in the study,
providing they meet specific eligibility requirements.

The clinical trial will test the safety and effectiveness of
the blood substitute called PolyHeme in comparison to standard
care in people who are critically injured and bleeding due to
traumatic injuries from such incidents as shootings, motor
vehicle crashes or construction-site accidents.

For eligible trauma victims, participation in the clinical
trial will begin before their arrival at the Duke emergency
department, either at the scene of injury or in an ambulance.
Along with standard supportive care, they will receive either
PolyHeme or a saline (salt water) solution. PolyHeme may be
administered for up to 12 hours post-injury while the person is
hospitalized. Those initially given saline solution on the way
to the hospital will receive blood rather than PolyHeme, if
needed, once they reach Duke. The study will be conducted by
personnel in Duke Hospital's Trauma Center, with help from
Durham County EMS. The EMS group completed training for the
PolyHeme trial earlier this month.

Researchers will compare the survival rates of people who
receive the blood substitute to those receiving the usual
treatment with saline solution. Due to the extent and nature of
their injuries, most people who are eligible for this study
will be unable to provide informed consent for participation in
the trial. For those unable to give informed consent, the study
will be conducted under federal regulations that allow for
clinical research in emergency settings using an exception (21
CFR 50.24) from the requirement for informed consent.

Federal regulations require "waiver of consent" study
investigators to hold public meetings to educate the community
in which the trial is to be conducted; answer questions from
the community about the study; and obtain feedback from
citizens regarding the proposed clinical trial. Public meetings
to discuss the PolyHeme study were held in Durham over several
weeks last summer. According to the investigators, the proposed
study met with majority approval by citizens who attended the
meetings.

People who do not wish to participate in this clinical trial
-- should they experience traumatic injuries -- can opt out of
the study by obtaining an "opt out" bracelet from Duke. To opt
out, they should send a letter to Dr. Steven Vaslef, DUMC Box
2601, Duke University Medical Center, Durham, NC, 27710, or
contact Angela King at 919-668-8686, or via email at:
king0037@mc.duke.edu. Please specify "PolyHeme" or "Opt Out" in
the subject line.

"This is a groundbreaking clinical trial for a much-needed
blood substitute and we're very pleased to be involved," said
Steven Vaslef, M.D., medical director of the Duke Trauma Center
and lead investigator at the Duke study site. "Traumatic injury
is a leading cause of death in Americans, but no one expects to
be injured. It is vitally important to treat trauma patients as
early as possible. The treatment process typically begins at
the scene of injury, so if PolyHeme proves to be effective,
having the ability to use it to provide treatment with an
oxygen-carrying solution means we'll be better able to keep
their hemoglobin levels up and increase their likelihood for
survival."

Approval for the clinical trial was given by the Duke
Institutional Review Board (IRB) late last year. The Duke IRB
is the executive body responsible for ensuring that clinical
trials at Duke University Medical Center are conducted with the
highest ethical standards and most rigorous scientific
criteria. The Durham County Board of Commissioners voted on
Nov. 8, 2004 to approve the contractual agreement between Duke
University Hospital and Durham County Emergency Medical
Services (EMS). The North Carolina Medical Board has also
approved the study. Earlier this year, Duke was one of five
North Carolina-based medical centers to petition for a state
rules change regarding waiver of consent clinical trials. Both
the NC Medical Care Commission and the NC Review Commission
approved a rule change that permits waiver of consent in
emergency situations. The new rule went into effect on April 1,
2005.

To be considered eligible for this study, a trauma victim
must be at least 18 years old, critically injured, losing a
large amount of blood and in shock. Only patients who are to be
transported to Duke by Durham County EMS ground ambulances will
be considered for this study, as air transport medical teams
have access to and can provide blood transfusions en route to
the trauma center.

Most ground transport ambulances do not carry blood on board
because of storage, temperature and compatibility concerns. The
current standard of care calls for the use of saline solution
in situations where blood is not available -- such as at the
scene of an accident or in an ambulance -- to compensate for
lost blood volume in patients who have sustained significant
blood loss. Lost blood volume, and the corresponding drop in
blood pressure, can lead to oxygen- and nutrient-starvation in
vital organs of the body. Continued lack of tissue perfusion
can lead to organ failure and eventually to death, the
researchers said.

Saline solution can be used in place of human blood to
increase volume in the blood stream, but it cannot deliver
oxygen in sufficient quantities. The blood substitute PolyHeme
is capable of efficient delivery of oxygen to patients, and it
creates less risk of disease transmission, and has a shelf-life
of 12 months as opposed to the 42-day shelf life of whole
blood, the researchers said.

"We're hopeful that the blood substitute will be effective,"
Vaslef added. "It may be better and safer than human blood,
because it's universally compatible across all blood types. But
that remains to be proven."

Unintentional injuries are the leading cause of death among
Americans under 35-years old, according to the National Center
for Injury Prevention and Control (NCIPC), part of the Centers
for Disease Control and Prevention. Such injuries are the
second leading cause of death among Americans aged 35-44. The
NCIPC's most recent statistics are based upon data collected in
2001.

Northfield Laboratories Inc., of Evanston, Ill.,
manufacturer of PolyHeme, is funding the study. PolyHeme is a
universally compatible, oxygen-carrying resuscitative fluid
designed for use in urgent blood-loss situations where blood is
not immediately available. Vaslef holds no financial interest
in Northfield Laboratories, Inc.

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