Accident victims to receive plasma treatment as part of study
The University of Louisville soon will launch a clinical study to determine the effects of infusing plasma to accident victims during air ambulance transport — and has set up mechanisms for people who don't want to participate to opt-out of the trial in advance.
The Pre-hospital Air Medical Plasma trial — known as “PAMPer” — will start in 2014. The trial involves infusing two units of AB universal-donor plasma into patients in shock during air medical helicopter transport and then evaluating the 30-day mortality rate. Shock occurs when massive bleeding prevents adequate blood flow to vital organs.
The trial also will examine the effects of plasma on other clinical outcomes such as clotting measurements on arrival to trauma center, total blood transfusion requirements during the first 24 hours, the development of multiple organ failure, hospital-acquired infection, acute lung injury and transfusion-related acute lung injury.
The University of Pittsburgh is the coordinating center for this multi-center clinical trial. The University of Louisville Hospital Trauma Center, working with the University of Louisville Department of Surgery, is the only trauma center in Kentucky participating in the trial. Brian G. Harbrecht, director of trauma surgery, is principal investigator at UofL.
“Although advances in the care of significantly injured patients have occurred over the past decade, the most acute threat to these patients is uncontrolled hemorrhage or bleeding, resulting in severe complications or even early death” Harbrecht said. “One reason for uncontrolled hemorrhage is the early failure of blood clotting after injury. Essentially, if the injury is too large, the body runs out of the factors to form blood clots to stop the bleeding.”
Across the country, however, surgeons are seeing lower rates of complications — such as multiple organ failure and increased survivorship — through use of early blood product transfusion. One such product, plasma, contains multiple clotting factors, and type AB plasma can be used in any patient without fear of incompatibility.
“If plasma treatment proves beneficial, this study could provide a roadmap for many other emergency services to use plasma nationwide,” Harbrecht said.
The study is designed specifically for patients who have life-threatening bleeding and shock who are unable to provide their consent. People who do not want to participate for religious or other personal reasons, however, can register in advance to opt out.
Individuals who do will receive a flexible, rubber-like wrist bracelet to wear to notify emergency personnel that they have opted out of the study, should they become an accident victim. Any accident victim wearing the bracelet will not receive plasma as part of the study.
People who do not wish to participate in the study can obtain an opt-out bracelet in one of several ways:
- By phone: Locally, 502-852-7637 or toll-free at University of Pittsburgh trial coordinating office, 1-855-730-8140
- In writing: Addressed to “Plasma Study at the University of Louisville Department of Surgery,” 550 S. Jackson St., Louisville KY 40292
- By email: UofL Research Coordinator Laura Trachtenberg at firstname.lastname@example.org or the trial email address, email@example.com
“We expect this study will improve the care of severely injured patients, not only in our area but ultimately everywhere,” Trachtenberg said. “At the same time, we respect the beliefs of everyone in our community and are giving anyone the opportunity to opt out who wants it.”
Besides UofL, other participating centers include Case Western University, the University of Tennessee, the University of Texas Southwestern Medical Center and Vanderbilt University.