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America's poorest citizens sometimes own little more than their bodies, but in North Carolina, they may not even own that
if Duke University has its way.
North Carolina is considering changing a rule that requires potential human guinea pigs to approve the act when medial
research wants to use their bodies for its experiments - but only for emergency room patients. Is it coincidence that these
patients just happen to be societies' poorer, less-educated, less-likely-sue citizens? Citizens who are less likely to sue
the University?
Duke University is trying to get North Carolina to change it's consent law for human subjects research so that it may
conduct "community meetings" to educate area residents about its plans to test a blood substitute on emergency room
trauma patients who are not conscious at the time of the "experiment." These potential "research subjects"
are, of course, those least likely to attend such "educational" meetings to learn that they may "opt out"
of the tests while they are still conscious.
While the purpose is laudable, the infringement on civil liberties would probably not be allowed if it targeted patients
who wre better able to protect their rights. -AMJ, CGISC 3/4/05
Duke's story:
Blood Substitute to be Tested at Duke University Hospital
date : 5/13/2004
media contact : Tracey Koepke , (919) 684-4148 or (919) 660-1301 koepk002@mc.duke.edu
DURHAM, N.C. Researchers and clinicians at Duke University Hospital plan to participate in the nation's first phase three
clinical tests of an oxygen-carrying blood substitute in trauma patients before they reach the emergency room. Beginning this
summer, they hope to join researchers at other trauma centers in the U.S. to test the safety and efficacy of the blood substitute
called PolyHeme in people who are critically injured and bleeding due to traumatic injuries from such incidents as shootings,
motor vehicle crashes or construction-site accidents.
Treatment of the trauma patients with the blood substitute would begin before their arrival at the Duke emergency department,
either at the scene of injury or in an ambulance, and continue for twelve hours post-injury while the patient is in the hospital.
The study will be conducted by personnel in Duke Hospital's Trauma Center, with help from Durham Emergency Medical Services.
"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 having the ability to provide
treatment with an oxygen-carrying solution may increase the likelihood for survival."
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.
Researchers will compare the survival rates of patients who receive the blood substitute to those receiving saline solution.
Due to the extent and nature of their injuries, patients who are eligible for this study will not be able 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.
The Institutional Review Board (IRB) at Duke University Medical Center requires the study investigators to hold public
meetings to educate the public and answer their questions about the PolyHeme study in lieu of informed consent, for what is
considered to be a "waiver of consent" clinical trial. Duke's participation in the study is contingent upon IRB
approval. The public meetings will be held in Durham, N.C. beginning on May 17. (A complete list of meeting times and locations
appears below.)
"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 underway at six trauma centers in the U.S. Approximately 20 hospitals
will eventually participate in the study which is expected to enroll 720 patients.
To be considered eligible for this study, patients 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 ground ambulance 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.
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 does not receive financial compensation from Northfield Laboratories, Inc.
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