Norfolk Fire-Rescue Participates in PolyHeme® Study
By: Robert Sayles and Mike Staats
In 1968, R. Adams Cowley, the physician responsible for the establishment of the Shock Trauma Center in Maryland, introduced the United States medical community to the idea of the “Golden Hour.” The basic idea centered on providing emergency care to severely traumatized patients within sixty minutes after sustaining a life-threatening injury. It was a huge step forward in terms of saving lives and still today, EMS instructors teach the concepts of the golden hour as a cornerstone of field medicine. Since that time, EMS services across the country have looked for ever increasing ways to positively influence trauma patient outcomes by developing skills, increasing knowledge, and utilizing new trends in technology.
Norfolk Fire-Rescue is one such service. It is one of 20 nationwide EMS agencies selected to participate in an important study on the effectiveness of a newly developed blood substitute called “PolyHeme®.” PolyHeme® is an intravenous fluid developed by Northfield Laboratory, Inc. According to information on the company’s website, “PolyHeme® is a unique human hemoglobin-based oxygen-carrying blood substitute in development for the treatment of urgent, large volume blood loss in trauma and surgical settings, with a particular focus on settings where blood is not immediately available.” Of course this is all well and good to be sure, but what does this mean in terms of patient care? The bottom line is that this product study addresses some of the limitations of using a crystalloid solution such as normal saline.
The study started on Thursday, September 30 as coolers, complete with product, were delivered to the 11 medic units that will carry the potentially life saving fluid. Providers may not be familiar with this PolyHeme® right now, but early results indicate that—similar to R. Adams Cowley’s golden hour—this product has the potential to take EMS care in this area to the next level.
When dealing with the trauma patient, EMS providers know that a 3:1 crystalloid to colloid ratio is the fluid replacement standard with the reality being that if a person loses 2 units of blood in an injury, it would take 6 units of crystalloid solution to compensate for the loss based on the formula—probably not the best course of action for someone with respiratory compromise due to heart problems. Crystalloids such as normal saline have no oxygen carrying capability, therefore, the use of a fluid with the characteristics of PolyHeme® negates these issues. The Northfield product has an ability to carry oxygen that is on a 1:1 fluid replacement ratio when comparing PolyHeme® to whole blood. Furthermore, the Northfield product also boasts a shelf life of over a year when stored properly.
Of course, Norfolk’s envious position of notoriety in terms of participating in the study also comes at a price. It was no small task to select persons to go through the train-the-trainer style classes that readied Norfolk Field Training Instructors to school hundreds of department members on the details of randomizing a trauma patient into the study. Actually getting to a point where a person may receive PolyHeme® requires the patient to meet a group of inclusion as well as exclusion criteria before they are enrolled in the study. Once enrolled, the patient may still not receive the PolyHeme®, dependent on what group the person is randomized to.
The PolyHeme® program in Norfolk is set to run approximately one year and will attempt to capture data on at least 30 patients. All of Norfolk’s medic units will be issued a cooler for storing the product. Synthetic reusable ice packs are used for cooling. Northfield has also provided freezers for the specific purpose of ensuring that the product can be kept cold at all times. Coolers are checked twice a shift and ice packs are changed as well.
Both Sentara and Northfield have gone to great lengths to make the public aware of this program, including those who do not wish participation due to religious beliefs. In this case, prefabricated wristbands stating no participation have been issued in order to identify those people.
This study hopes to prove that PolyHeme® will reduce the risk of death in patients with blood loss due to trauma, as well as reduce the risks associated with blood transfusions.
Norfolk Fire Rescue is honored to be a part of such a significant study that could revolutionize the future of patient care and make a significant impact on patient survivability.