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University of Tennessee Medical Center Participates in Plasma Delivery Study

In matters of life and death, minutes can mean a different outcome.

A clinical trial at University of Tennessee Medical Center seeks to find out how much of a difference it might make if trauma patients being airlifted with uncontrolled bleeding get blood plasma treatments before they even get to the hospital.

The medical center and its LifeStar helicopters are one of six sites participating in the Pre-hospital Air Medical Plasma Trial (PAMPr), a stage 3 clinical trial backed by the U.S. Department of Defense and headed up by the University of Pittsburgh.

The military has found giving plasma, which can clot, more quickly to soldiers injured in combat zones resulted in better survival rates, said Dr. Brian Daley, UTMC trauma medical director and principal study investigator. This new trial will see if a civilian population of varying ages and health conditions fares as well as soldiers, who are generally younger and healthier, he said.

It’s the timing, rather than the treatment itself, that’s being tested. Many trauma patients already get plasma once in the hospital’s emergency department, in an attempt to stop hemorrhaging and significant blood loss, which can lead to low blood pressure, multiple organ failure and other issues that greatly increase the risk of death or disability.

The trial will test whether there’s an advantage to getting those patients the plasma at the earliest possible moment: during transport via LifeStar to UTMC, which can be anywhere from 20 minutes to two hours, depending on the patient’s location, Daley said.

“We already know there’s benefit, but we’re trying to adjust the timing and look for adverse reactions,” he said. “We’re hopeful, but as scientists, we wait for the evidence.”

Initially, two units of AB plasma — the type given in emergencies before the patient’s blood type is known — will be placed on the LifeStar copter based in Morristown. Once a routine is established, the other three LifeStar copters will likely carry plasma as well, said LifeStar medical director Dr. Chris Brooks. It will be given in-flight to qualifying trauma patients every other month, with the non-plasma months serving to form a “control group.”

The hope, is that the trial will show great benefit to the patients, which will then make in-flight plasma treatments a standard of care, Brooks said.

That could change the way Medic Regional Blood Center, the sole supplier for UTMC and other area hospitals, collects plasma, said Medic chief operating officer Eva Quinley. Blood type AB plasma is “universal,” used in emergencies when a patient’s blood type is unknown, just as Type O red blood cells are.

But less than 4 percent of the population has blood type AB, Quinley said, and a new protocol suggests blood centers collect AB plasma only from men or from women who have never been pregnant, because women who have carried children sometimes have an antibody that render the plasma unusable in emergency situations, and testing for it on a large scale is cost-prohibitive.

Quinley said Medic is able to supply UTMC’s AB plasma needs for this trial, but if it becomes a standard of care, Medic may change its own protocol. Currently it gets plasma by taking whole-blood donation and separating the red blood cells from the plasma, both for use.

However, there’s much less demand for AB red blood cells than for AB plasma, so if the demand for AB plasma locally increases, Medic might invest in a machine that takes only plasma and returns the red blood cells to the body, Quinley said.

Daley said UTMC is “very good about making sure blood products never get wasted.” For him, the most time-consuming part of setting up the study has been obtaining “community consent” — the formal board-reviewed process that means that by becoming a LifeStar trauma patient, people are considered to have “consented” to participate, unless they “opt out” by wearing a bracelet (or carrying a card, as Jehovah’s Witnesses and others with religious prohibitions do). Even though the risk is “minimal” — patients would get the plasma anyway, just later — it took about 16 months to get consent, he said. Community members can “opt out” by calling Meghan Buck at 855-730-8140 or visiting http://pamperstudy.com.

Otherwise, patients ages 18 to 90 are eligible, with some exceptions, such as those with penetrating head wounds, or drowning or hanging victims. Brooks said LifeStar typically transports up to 1,250 trauma patients a year.

“There’s some good evidence this will significantly improve outcomes for these patients,” he said. “Every time we have a war, we have an advance in trauma care.”



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