Vanderbilt University Medical Center will participate in a national trial to see if outcomes for critically injured patients with uncontrolled bleeding can be improved by administering plasma to these patients while in flight to the hospital.
In a first-of-its-kind study, randomized patients who are at risk of hemorrhaging and flown to Vanderbilt University Hospital via LifeFlight’s Clarksville, Tenn., base could receive two units of plasma, which can improve a patient’s ability to clot and ultimately survive their injuries.
Plasma is one of several components derived from donated blood and is comprised of vital clotting factors.
This plasma will be administered in addition to standard of care, which already includes packed red blood cell transfusion in flight when needed.
Uncontrolled bleeding is one of the most serious threats to the severely injured patient, often resulting in early death or the development of complications such as multiple organ failure.
Funded by the U.S. Department of Defense (Grant No. W81XWH-12-2-0023), the Prehospital Air Medical Plasma (PAMPer) trial will assess whether a pre-hospital infusion of AB plasma, the universal plasma donor, can improve mortality and reduce the total amount of blood transfusions needed as compared to standard air medical care.
“When patients are critically ill, their ability to clot is severely impaired,” said Richard Miller, M.D., Chief of Trauma and Surgical Critical Care, professor of Surgery and primary investigator for the Vanderbilt PAMPer trial site. “The thought process on this study is that the plasma, which is separated from blood cells when a person donates blood, will improve the body’s ability to clot and thus improve the patient’s chance of arriving at our hospital alive. By administering the plasma in the pre-hospital setting [LifeFlight], our hope is that patients will start clotting faster, thus reducing the risk for organ failure and eliminating the need for as much blood overall.”
Beginning in early 2014, Vanderbilt will enroll patients in the trial who have blunt or penetrating injuries and are suffering from significant blood loss.
Vanderbilt LifeFlight, Tennessee’s largest not-for-profit air medical transport program, is the only air medical service in the region that carries lifesaving blood for needed transfusions while in flight to the hospital. Plasma will be added to LifeFlight’s Clarksville, Tenn.-based helicopter and will be administered for a month at a time at random intervals to patients who may also receive blood. The Clarksville-based aircraft is the only one of LifeFlight’s fleet of five helicopters that will carry plasma.
Researchers will compare the effect of the pre-hospital infusion of plasma versus current standard of care on 30-day mortality in patients with hemorrhagic shock and will also examine the clinical outcomes, including blood transfusion requirements and the development of multiple organ failure.
“Patients who arrive at Vanderbilt alive have a 95 percent chance of surviving their injuries, which makes pre-hospital patient care a highly critical component to the patient’s overall survival,” Miller said. “This trial paves the way for advances in pre-hospital care that can ultimately save more lives.”
Led by the University of Pittsburgh, the four-year study will enroll 530 patients across six total sites, with Vanderbilt’s enrollees accounting for approximately 25 patients per year.
Because patients who have suffered these kinds of injuries are likely unable to consent to participation in the trial, the PAMPer study will be conducted under a federally authorized exception from informed consent process that includes a means to opt out of inclusion. Community members who do not wish to participate in this research study can obtain a bracelet to opt out by contacting Clinical Research Director Judy Jenkins, MSN, R.N., toll-free at (855) 730-8140. More information on the trial is available at http://pamperstudy.com.