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Blood Substitute Study to Proceed at Duke University Hospital

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Duke Health News 919-660-1306

DURHAM, N.C. – A clinical trial designed to test an oxygen-carrying
blood substitute in trauma victims being transported to Duke University
Hospital has received approval from Duke's Institutional Review Board
(IRB).

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 IRB's approval clears the way for researchers
and clinicians at Duke University Hospital to begin enrolling study
participants in January. The Durham County Board of Commissioners voted
on Nov. 8 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.

The clinical
trial will test the safety and efficacy 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.

Delivery
of the blood substitute to trauma victims who are enrolled in the study
will begin before their arrival at the Duke emergency department,
either at the scene of injury or in an ambulance. PolyHeme may be
administered for up to 12 hours post-injury while the person is
hospitalized. The study will be conducted by personnel in Duke
Hospital's Trauma Center, with help from Durham County EMS.

"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 of trauma
victims begins at the scene of injury. Having the ability to provide an
oxygen-carrying solution may increase the likelihood for survival."

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 with 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.

Researchers will compare the survival rates of
people who receive the blood substitute to those receiving saline
solution. Due to the extent and nature of their injuries, people who
are eligible for this study will be unable to provide informed consent
for participation in the trial. Therefore, 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 a period of 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 call Sally Everett at 919-668-0283.

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

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.

The PolyHeme study is a multi-center trial currently
under way at 16 trauma centers in the U.S. Approximately 20 hospitals
will eventually participate in the study, which is expected to enroll
720 trauma victims. Vaslef's team expects enrollment for the PolyHeme
study to begin following a training period of several weeks for Durham
County EMS personnel. Training is expected to begin in early December.

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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