LOUISVILLE, Ky. – The University of Louisville will soon 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 to opt-out of the trial in advance, should they choose.
The Pre-hospital Air Medical Plasma trial – known as “PAMPer” – will get underway 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, with Director of Trauma Surgery Brian G. Harbrecht, M.D., serving as 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.
Because the study is designed specifically for patients who have life-threatening bleeding and shock who are unable to provide their consent, it will be conducted under an exception from the requirement for informed consent for emergency research. Also in this trial, treatment must be started immediately in the helicopter en route to the trauma center, and so family would not be able to be contacted to provide consent for their loved ones.
The study has a mechanism built into it, however, to identify those patients who want to opt out of treatment because of religious or other personal reasons. Patients who register in advance to opt out will receive a flexible, rubber-like wrist bracelet to wear that immediately will 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 a bracelet to opt out in one of several ways: