UK Continues Study of Blood Substitute for Trauma Patients
The University of Kentucky is taking part in a national clinical research trial, with at least 22 other trauma centers across the country, to evaluate the ability of a blood substitute to reduce death rates among 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 blood substitute, PolyHeme®, is produced from and carries oxygen in the same way as human blood. PolyHeme is universally compatible with all blood types, can restore lost blood volume and can be rapidly and massively infused. The study investigates whether PolyHeme increases survival of critically injured patients. Since last May, the blood substitute has been carried on most emergency medical helicopters in Kentucky and ambulances in some Central Kentucky counties.
Andrew Bernard, a trauma surgeon at the UK Hospital and assistant professor of surgery in the College of Medicine, is leading UK’s contribution to this trial. 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 says.
Northfield Laboratories in Evanston, Illinois, which manufactures the blood substitute, hopes to enroll 720 patients in the nationwide, one-year study. Bernard expects to enroll 40 to 50 patients at UK.
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. So the study is being conducted under a federal regulation that allows such research an exemption from the informed consent requirement at the time of enrollment in certain emergent, life-threatening situations.
Trauma victims who are transported by emergency medical services in Kentucky to the UK Hospital Trauma Center, who are at least 18 years old and who have low blood pressure within normal limits can be included in the study. While in route to the hospital, they receive either the usual saline solution to boost blood pressure (control group) or PolyHeme.
Once at the hospital, control group patients receive saline for hydration and blood transfusions as needed to boost oxygen levels. Those on PolyHeme receive saline for hydration and up to six units of the blood substitute during the first 12 hours to boost oxygen levels. Blood transfusions are given after that. Patients who receive PolyHeme may require less donated blood which, in large volumes, can suppress immunity. PolyHeme has not been shown to suppress patients’ immune systems in some of the same ways as donated blood.
Efforts are made to notify family members of the patient’s enrollment in the study. When notified, they are offered the choice of allowing the patient to continue in the study or to withdraw. In either case, the patient continues to receive the best medical care available.
In mid-November, Northfield Laboratories announced results from the first 500 patients. The trial’s data analysis committee reviewed the data, identified no significant differences between the two groups, and recommended that the trial continue without modification.