Study Closed to Enrollment December 2, 2013
Traumatic injuries, like those caused by car accidents, are the leading cause of death in people under the age of 45. The main reason for death is severe blood loss. When a person suffers a serious injury leading to massive blood loss, a blood transfusion is imperative to save the patient’s life.
But a blood transfusion does not simply transfer stored blood to the patient. Other blood products such as plasma and platelets may also be transfused. There are many accepted ratios of blood products (red blood cells, plasma and platelets) that are used in different trauma centers. Yet little research has been conducted to see if there are differences in patient outcomes correlated to the different ratios of products used.
To find out more about Blood Types and Blood Transfusions
The University of Arizona Division of Trauma, Critical Care and Emergency Surgery is one of only a dozen trauma centers in the United States and Canada selected to conduct a clinical trial that could lead to an improved outcomes for trauma patients who require massive blood transfusions.
The multi-center study, PROPPR – Pragmatic, Randomized Optimal Platelet and Plasma Ratios - is sponsored by the National Heart Lung and Blood Institute, the U.S. Department of Defense (DOD), the Defence Research and Development Canada and the Resuscitation Outcomes Consortium.
The Purpose of the Study
The purpose of this research is to evaluate the effectiveness of two 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 ratio (1 unit of red blood cells, 1 unit of plasma, and 1 unit of platelets) and 1:1:2 ratio (1 unit of plasma, 1 unit of platelets and 2 units of red blood cells). Both combinations already being widely used across the United States.
Banner - University Medical Center Tucson (BUMCT), the only trauma center in the Southwest involved in the study, hopes to enroll at least 44 patients during the two year trial period. UA trauma surgeon Terence O’Keeffe, MD, Associate Professor of Surgery and Medical Director of the Surgical/Trauma Intensive Care Unit, is leading the study at the BUMCT.
How the Study Works
Patients who are admitted to BUMCT with severe traumatic injuries and need a massive transfusion to survive, will be randomized to receive one of the two transfusion ratios – 1:1:1 or the 1:1:2.
Currently, there is no scientific evidence that proves one ratio is better than the other. Results from this research will help determine the optimal ratio of plasma-to-red blood cells and this could lead to better patient outcomes.
Blood samples taken immediately upon arrival, during and after the transfusion will also be analyzed for coagulation factors, other proteins (e.g. complement) and inflammatory factors in an attempt to answer the research question, “Which ratio of blood products works better?”
You Have the Right to “Opt Out”
Because patients with traumatic injury may be unconscious and unable to give consent to participate in the study, the PROPPR trial falls under a unique Federal Drug and Administration (FDA) 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 physician in the trauma center the ability to enroll patients into the study even though they cannot speak for themselves because of life-threatening injury or illness.
One requirement of this regulation is that the community receive education about the study. We are getting the word out through television, newspaper and radio advertisements, as well as social media, telephone calls and town hall meetings.
Persons who do not wish to be included in the PROPPR study can request an opt-out bracelet that indicates to medical staff that the patient does not want to be included in this study. Your care at UAMC will not be affected in any way. You will continue to receive the highest standard of care regardless of your participation.
For more information on the study, or to request an opt-out bracelet, please call 520-626-5297 or email PROPPR@surgery.arizona.edu.