The University of Arizona Medical Center has been selected as one of a dozen Level 1 trauma centers in the United States and Canada to determine which combination of blood products are most effective in saving the lives of patients requiring massive transfusions.
The UA department of surgery will receive $1.7 million to conduct research over the next three years through the trial, PROPPR – Pragmatic, Randomized Optimal Platelet and Plasma Ratios. The trial is sponsored by the National Heart Lung and Blood Institute, the U.S. Department of Defense, the Defence Research and Development Canada and the Resuscitation Outcomes Consortium.
The University of Arizona Medical Center is the only trauma center in the Southwest involved in the study. UA trauma surgeon Dr. Terence O’Keeffe, associate professor of surgery and medical director of the Surgical/Trauma Intensive Care Unit, is leading the study at the The University of Arizona Medical Center.
The trial, which starts in September, will evaluate the effectiveness of the two most common ratios of blood products used to transfuse trauma patients suffering from massive blood loss. The study will compare two blood transfusion combinations: 1:1:1 (one unit of red blood cells, one unit of plasma and one unit of platelets) and 1:1:2 ratio (two units of red blood cells, one unit of plasma and one unit of platelets). Both combinations are in widespread use across the United States.
A total of 580 patients with blunt or penetrating trauma will be enrolled in the study from the 12 participating sites in the United States and Canada. The University of Arizona Medical Center hopes to enroll at least 44 patients in the trial during the three-year trial period. Patients who qualify for the study include those admitted to The University of Arizona Medical Center with severe traumatic injuries and predicted to need a massive transfusion to survive. These patients will be randomized to receive one of the two transfusion ratios.
Because patients with traumatic injury may be unable to give consent to participate in the study, the PROPPR trial falls under the unique U.S. Food and Drug and Administration regulation concerning "exception from informed consent." Such regulations are strict and the research must meet very specific federal regulations and local Institutional Review Board review and approval. They give the researcher the ability to enroll patients into the study when they cannot speak for themselves because of life-threatening injury or illness.
Exception from informed consent requires that the community receive education about the study. The UA is getting the word out through television, newspaper and radio advertisements, as well as social media, telephone calls and town hall meetings.
Anyone who prefers not to be in the study in the event of a significant trauma can request an opt-out bracelet that indicates to paramedics that the patient declines to be part of this study. Trauma victims age 15 and older who weigh at least 110 pounds and who are not wearing the band can be considered for inclusion in the PROPPR study.
“We‘re telling everyone we can that if you don’t want to be in the trial you can wear a wrist band similar to the yellow rubber Livestrong bands,” O’Keeffe said.
O’Keeffe said the issue of red-blood-cells to plasma ratio in transfusions has been debated for years. He hopes the study will determine the better course of action for patients requiring massive transfusion.
The UA underwent a highly competitive selection process to take part in the trial. O’Keeffe and Dr. Peter Rhee, UA professor of surgery and chief of the Division of Trauma, Critical Care and Emergency Surgery, have been involved in this type of research, with O’Keeffe having examined this topic at Parkland hospital in Dallas, as well as taking part in a U.S. Army-sponsored study of massive transfusion practices in civilian trauma centers.
Dr. Rainer W.G. Gruessner, chairman of the UA department of surgery, said the UA trauma program was chosen because of its national reputation as a leader in trauma care. “We are becoming more and more engaged in top-notch, federally funded national studies.”
Dr. Deborah J. Novak, UA assistant professor of pathology and director of Transfusion Medicine, said PROPPR will use state-of-the-art research methods that are expected to provide the most reliable data.
“Whole-blood donations are physically divided into components: red blood cells for oxygen-carrying capacity, plasma for coagulation factors to stop bleeding and platelets, which are small pieces of cells that circulate in our blood streams to help stop bleeding,” Novak said. “When patients are treated for massive bleeding due to traumatic injuries, providing red blood cells has always been important."
“But physicians caring for soldiers with traumatic injuries noticed the problems with bleeding during treatment actually responded better when plasma was administered sooner in the treatment than formerly was the standard.”
Numerous scientific studies, mostly from the military medical community, have examined this issue, Novak said.
“However, we believe certain methods of performing studies provide the most reliable data, and numerous researchers seek clarification regarding the correct mix of red blood cells, plasma and platelets using the best research method for collecting the information,” she said.
“The trial is the first of its kind and it is expected to have national, and potentially global, impact,” O’Keeffe said. “We hope to determine what ratio is best for patients.”