Evaluating the ability of an investigational blood substitute PolyHeme®
By University of Kentucky
Sep 20, 2005, 22:07

The University of Kentucky is continuing to take part in a national clinical research trial, along with 22 other trauma centers across the country, to evaluate the ability of an investigational blood substitute to reduce mortality among severely injured trauma patients.

Nationally, 400 patients have been enrolled in the study as of June 30, 2005. 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 investigates whether PolyHeme, with its oxygen-bearing capacity, increases survival of critically injured and bleeding patients.

PolyHeme is manufactured by Northfield Laboratories Inc. of Evanston, Ill. Data from the trial is monitored nationally by an independent data monitoring committee (IDMC). The IDMC is a group of experts, not associated with Northfield, responsible for periodically evaluating the safety data from the study and making recommendations relating to the continuation or modification of the study to minimize any identified risks to patients.

It was the first time a hemoglobin-based oxygen-carrying resuscitative fluid has successfully passed this patient evaluation milestone in a Phase III clinical trial in the high-risk trauma population.

Since last May, the blood substitute has been carried on most emergency medical helicopters in Kentucky and ambulances in some Central Kentucky counties.

The selected trauma centers, including UK Hospital’s, are evaluating the safety and effectiveness of an oxygen-carrying blood substitute in treating severely injured and bleeding patients. Andrew Bernard, 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 are 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 research study will be able to provide informed consent. The UK research team, under the direction of the UK Medical Institutional Review Board (IRB), 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.

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 approved the study to be conducted at UK. UK Emergency Medical Services personnel and hospital staff completed the necessary training before the clinical trials began.

While in route to the hospital, study
participants receive either the usual saline solution to boost blood pressure (control group) or PolyHeme. Not all patients transported by emergency medical services are eligible for the study, but all patients continue to receive the best emergency medical care available.

Once at the hospital, control group patients receive saline for hydration and blood transfusions as needed to boost oxygen levels. All trauma victims given PolyHeme must be treated at UK.

Throughout the process, efforts are made to notify family members of the patient’s enrollment in the study. Family members are offered the choice of allowing the patient to continue in the study or to withdraw.

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