Study of Blood Substitute Begins

Study of Blood Substitute Begins

Photo of Andrew Bernard, M.D.
Andrew Bernard, M.D.

The blood substitute, PolyHeme®, is universally compatible with all blood types and can be given to trauma victims in the field, whereas blood typically is not. The controlled study will investigate if PolyHeme, with its oxygen-bearing capacity, increases survival of critically injured and bleeding patients.

LEXINGTON, Ky. (April 21, 2004) -- The University of Kentucky is joining a select number of trauma centers across the country in a national clinical trial to evaluate the ability of an investigational blood substitute to reduce mortality among severely injured trauma patients.

About two million Americans suffer trauma-related injuries each year, and trauma is the leading cause of death among those under 45 years old. The selected trauma centers, including UK Hospital’s, will evaluate the safety and efficacy of an investigational oxygen-carrying blood substitute in treating severely injured and bleeding patients. More than 20 sites in the United States are expected to participate.

PolyHeme is manufactured by Northfield Laboratories Inc. of Evanston, Ill.

Andrew Bernard, M.D., trauma surgeon at UK Hospital and assistant professor of surgery, UK College of Medicine, is the principal investigator of Kentucky’s contribution to the national clinical trial testing PolyHeme.

Under the current standard of care, trauma patients receive saline solution for hydration in the field, and then their blood is typed and matched for transfusion at the hospital. Trauma patients who have lost massive amounts of blood display dangerously low blood pressure and are at risk of organ failure and death due to oxygen deprivation.

“The potential benefits of using the oxygen-bearing blood substitute in the pre-
hospital setting is to boost oxygen levels earlier in treatment, which could protect major
organs and improve patient survival rates,” Bernard said.

Northfield Laboratories proposes to enroll 720 patients in the nationwide study, which will last approximately one year. Bernard expects to enroll 40 to 50 patients at UK.

In this controlled clinical study, patients meeting the eligibility criteria will be assigned randomly to receive infusions of the current standard saline solution treatment or the investigational blood substitute.

Due to the extent and nature of their injuries, it is unlikely the patients eligible for this study will be able to provide informed consent. Consequently, the study will be conducted under a federal regulation that allows such research an exemption from the informed consent requirement in certain emergent, life-threatening situations.

The UK research team, under the direction of the UK Medical Institutional Review Board (IRB), recently completed a process of community notification and consultation, as is mandated by this federal regulation. The researchers made presentations to various groups in several Kentucky communities to explain the study.

Composed of members with medical, scientific and non-scientific backgrounds, the IRB’s responsibility is to ensure the protection of the rights, safety and well-being of patients enrolled in clinical trials. Based on its comprehensive review of the study protocol, the results of previous studies of this blood substitute, and the response of the community to consultation regarding the study, the IRB has given approval for the study to be conducted at UK. UK Emergency Medical Services personnel and hospital staff have completed the training necessary for the clinical trials to begin.

Beginning in early May, PolyHeme will be carried on most emergency medical helicopters in Kentucky as well as ambulances in some Kentucky counties. In the research protocol, trauma victims who are transported by emergency medical services from participating counties, who are at least 18 years old, and who have a systolic blood pressure less than or equal to 90mmHg are eligible for the study. While in route to the hospital, study participants will receive either the usual saline solution to boost blood pressure (control group) or PolyHeme. Not all patients transported by emergency medical services will be eligible for the study, but all patients will continue to receive the best emergency medical care available.

Once at the hospital, control group patients will receive saline for hydration and blood transfusions as needed to boost oxygen levels. Those on PolyHeme will receive saline for hydration and up to a total of six units of the blood substitute during the first 12 hours. Blood transfusions will be used after that. All trauma victims given PolyHeme must be treated at UK.

Efforts will be made throughout the process to notify family members of the patient’s enrollment in the study. Family members will be offered the choice of allowing the patient to continue in the study or to withdraw. If they choose to withdraw, there will be no disruption of care or harm to the patient.

Under the study’s protocol, potential patients who do not wish to participate may opt out by obtaining a bracelet from study coordinators, similar to other medical alert identifiers. Those who do not wish to participate in this study for religious or other reasons may contact the PolyHeme hotline, (859) 323-6346 ext. 248, to obtain a bracelet expressing this choice or e-mail. For additional information, visit the PolyHeme Web site.