The University of Arizona has been approved for $30.6 million in research funding from the Patient-Centered Outcomes Research Institute, or PCORI, a nonprofit organization that funds patient-centered comparative clinical effectiveness research (CER) designed to provide patients and those who care for them with evidence to make informed healthcare decisions.
This funding will support research conducted as part of a large public health initiative to implement and evaluate prehospital blood transfusion, which is the administration of blood or blood components to patients either at the scene of an accident and/or en route to the hospital in patients receiving ground-based emergency medical services. The team's ultimate goal is to analyze prehospital blood transfusion compared with the standard treatment which involves the use crystalloid fluids such as saline in reducing the number of deaths associated with traumatic hemorrhagic shock, or THS – a life-threatening medical emergency that involves quick and massive blood loss.
"The most frequent cause of death after trauma is bleeding. So, it makes intuitive sense that if you give the patient blood, they might have a better chance of survival – in multiple settings where injury occurs a long way from the hospital, this intervention has been shown to be effective," said Dr. Joshua Gaither, the project's co-principal investigator and a professor of emergency medicine at the College of Medicine – Tucson.
Prehospital blood transfusions are currently used in multiple settings – including some ground based EMS systems, air EMS and in military EMS care – and are considered by many to be the standard of care. However, in urban settings, where the time from when the injury occurs to the time at which the patient arrives at the hospital is shorter, it is less clear whether prehospital blood transfusions could improve survival. Chengcheng Hu, professor of biostatistics in the Mel and Enid Zuckerman College of Public Health and the study's co-principal investigator, will lead the efforts to analyze the data necessary to answer this question.
"Thankfully, severe hemorrhagic shock is rare," Gaither said.
Only about one in every 1,000 cases that paramedics go to would require blood transfusions, according to Gaither.
Some emergency medical service agencies are already doing prehospital blood transfusions in Arizona and across the country, Gaither said, but for this project the U of A will partner with the Arizona Department of Health Services, ADHS, to evaluate the safety and effectiveness of this approach on a large state-wide scale.
"This public health initiative is really focused on two different aspects of prehospital blood transfusion – whether it works in a large state-wide population and whether it is safe. The study will help make the decision of where blood will be best utilized – the hospitals or the field," Gaither said.
Conducted in real-world care settings, this study will generate evidence on outcomes that matter to patients, helping them and their care teams make better-informed healthcare decisions.
"The University of Arizona has a long history of leadership in emergency care research, with world-class expertise, strong partnerships and the research infrastructure to turn discovery into better outcomes for patients," said Tomás Díaz de la Rubia, senior vice president of research and partnerships. "This project builds on our strengths in emergency medicine and public health to tackle critically important questions with real-world impact – helping ensure that the right intervention reaches patients when it can make the greatest difference and every minute matters."
The project will be conducted over the course of more than six years and during that time almost 2,000 patients are expected to be treated by more than a dozen EMS agencies participating in the program.
"PCORI funds patient-centered comparative clinical effectiveness research focused on outcomes that matter most to individuals and generates evidence to support the healthcare decisions patients and those who care for them face every day," said Nakela L. Cook, the executive director of PCORI. "By addressing a critical evidence gap in ground-based EMS care for traumatic hemorrhagic shock, this large-scale study has the potential to improve patient outcomes and the quality of care. We look forward to following its progress."
The funding award to the U of A has been approved pending completion of PCORI's business, programmatic review and issuance of a formal award contract.