Trauma study in Pittsburgh region won't need up-front approval
A planned medical study by the University of Pittsburgh and UPMC this summer might save your life — but you might not know you're in the study until after you've participated.
Dr. Jason Sperry, professor of surgery and critical care medicine at Pitt's medical school, is heading a study to improve the survival of patients with traumatic injuries and uncontrolled bleeding. Paramedics will administer plasma, a component of blood, to patients during transport in a STAT MedEvac helicopter instead of waiting until patients get to UPMC Presbyterian hospital.
Typically, participants in studies must give consent. Because patients with severe injuries likely cannot consent, the study will be conducted under a federally authorized exception that gives a person the choice to opt out of the study later.
“We currently use plasma to help reduce that tendency to bleed (in hospitals). So the next step is to bring it to the pre-hospital (situation) in a helicopter while in route,” Sperry said. “This is emergency research and so protocols are set up where the community is notified so this type of research can be performed.”
People who live in the telephone area codes of 412, 724, 814, 717 and 878 could be in the study. The research will include four other universities — Case Western Reserve, Louisville, Tennessee and Texas — and their surrounding areas.
Sperry said helicopters carry red blood cells for transfusions. Plasma that will be added for the study has not been available in helicopters because of problems with keeping unfrozen plasma. Helicopter paramedics will return to hospitals any plasma not used before its expiration.
Medical experts said exceptions to informed consent are common, and necessary, in emergency research.
“It could be beneficial to the patient, but we don't know. The plasma could save their life,” said Gerry Magill, a professor in the Center for Healthcare Ethics at Duquesne University. “To cover that knowledge gap, the government says, ‘This is important for the community.' I really don't think (it's an ethical issue).”
Vivian Shearer, 71, of Slickville, Westmoreland County, said she would have a problem with receiving any blood whether it's in a helicopter or at the hospital. As a Jehovah's Witness, she said her religious beliefs don't allow her to receive blood, including plasma.
Shearer said she carries a card on the outside of her wallet saying that she refuses blood transfusions, even at the risk of dying.
“In our (family's) records at hospitals and with our doctors we have things that say, ‘No blood transfusion,'” Shearer said. She said she underwent “bloodless” triple-bypass heart surgery a decade ago at Allegheny General Hospital.
A pre-study survey found 95 of 100 respondents agreed the plasma research study should be done. A telephone survey of 401 people in the five area codes found that 91 percent agreed, said Barbara Early, project manager for the study.
People who don't want to be included in the plasma study can call 412-864-1599 for an opt-out bracelet or more information.
Dr. Clifton Callaway, a Pitt professor and chair of emergency medicine research, said rarely do people complain when they find out later they were part of an emergency medicine study.
“In my own studies, I'm the one who talks to someone like that who says, ‘You did what? You should have asked my permission.' Frequently it's a lack of understanding,” Callaway said. “Really we're trying to give you more service and care.”
Bobby Kerlik is a Trib Total Media staff writer. Reach him at 412-320-7886 or email@example.com.
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