CINCINNATI—Researchers from the University of Cincinnati’s trauma and critical care division, along with the departments of emergency medicine, anesthesiology and pathology and laboratory medicine, will soon participate in a national clinical trial to determine the best ratio of blood products for trauma patients requiring massive transfusions.
Locally, it will be led by Peter Muskat, MD, associate professor of surgery and medical director for trauma services at UC Health University Hospital.
"Severe hemorrhage due to traumatic injury is the leading cause of death for people under the age of 45 years old, and many victims require specialized care such as massive blood transfusions (MT) and extensive surgery due to their injury,” says Muskat. "Those patients who require greater than 10 units of red blood cells early have a high mortality rate—historically approximately 45 percent. This study is an effort to improve outcomes for that group of patients.”
When patients receive an MT, they receive a mix of platelets, plasma and red blood cells. Current transfusion guidelines are based on the U.S. Army Surgeon General recommendation of a 1:1:1 ratio of platelets, plasma and red blood cells.
"However,” says Chris Miller, MD, UC assistant professor of emergency medicine and medical director for University Hospital’s emergency department, "studies in both civilian and military populations have shown that seriously injured patients who received an MT with higher plasma ratios had lower mortality compared to patients who received more traditional ratios.”
PROPPR was created to evaluate the effectiveness of the two most common MT ratios used for significantly bleeding trauma patients.
The study population includes severely traumatically injured patients admitted to University Hospital and predicted to need an MT. These patients will be randomized to receive one of two transfusions standard, either a 1:1:1 ratio or a 1:1:2 ratio of platelets: plasma: red blood cells.
"The PROPPR study,” says Miller, who is also part of the PROPPR research team, "will help those who care for severely injured trauma patients identify the best ratio of resuscitative blood products. This knowledge will likely impact how massively bleeding patients are transfused in the future. Hopefully, the data will help decrease the amount of otherwise preventable deaths as the result of hemorrhagic shock due to severe trauma.”
Because patients with traumatic injury may be unable to give consent to participate in the study, the PROPPR trial falls under the unique FDA federal 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.
"It is this type of clinical trial which enables us to make sure the patient receives the correct blood products necessary to sustain or improve their health,” says Patricia Carey, MD, UC associate professor of pathology and laboratory medicine.
Exception from informed consent requires that the community receive education about the study. To educate the community about PROPPR, coordinators will be speaking at public events and local meetings from May through June.