February 25, 2015

Vanderbilt to study use of plasma on LifeFlight, extends trial to Rutherford County base

Vanderbilt University Medical Center is participating 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.

Randomized patients who are at risk of hemorrhaging could receive two units of plasma, which can improve a patient’s ability to clot and ultimately survive their injuries.

The study is currently underway via LifeFlight’s Clarksville, Tenn., base and will soon be expanded to include some patients being flown to Vanderbilt University Hospital from the area covered by LifeFlight’s Rutherford County base.

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 plasma can improve mortality and reduce the total amount of blood transfusions needed as compared to standard air medical care.

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 with Vanderbilt LifeFlight, already includes packed red blood cell transfusion in flight when needed.

“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.”

Vanderbilt began the study in July 2014, enrolling patients from the Clarksville, Tenn., area suffering from significant blood loss due to blunt or penetrating injuries. LifeFlight’s Rutherford County base will be included in the trial starting in spring 2015.

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 has been added to LifeFlight’s Clarksville and Rutherford county-based helicopters and will be administered for a month at a time at random intervals to patients who may also receive blood. The Clarksville and Rutherford-based aircrafts are the only two 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 120 patients.

Because patients who have suffered these kinds of injuries are likely unable to consent to participate 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://www.pamperstudy.surgery.pitt.edu/.