(SALT LAKE CITY)鈥擳he University of Utah will join a multicenter clinical trial this summer to assess whether giving seriously injured trauma patients a blood-clotting agent as they're being transported by helicopter to the hospital improves survival rates.
It's estimated that up to 25 percent of patients with severe trauma injuries are at risk for severe bleeding, which can lead to multiple organ failure, infection and death. Research has shown that tranexamic acid, an agent that stops clot breakdown already given to patients having heart surgery, can lower mortality when administered in a hospital to severely injured trauma patients at risk for uncontrolled bleeding.
The U of U, the University of Arizona, University of Texas, San Antonio, and the University of Pittsburgh will conduct a three-year trial to rigorously investigate how effective tranexamic acid is when given to trauma patients during medical air transport. The University of Pittsburgh is leading the study, called STAAMP, which is projected to enroll nearly 1,000 patients nationwide over three years.
"We know that tranexamic acid is effective in the hospital after resuscitation and hemorrhage control has started, but we don't know if it will be as effective before reaching the hospital," said Ram Nirula, M.D., MPH, associate professor of surgery, chief of trauma and lead investigator for the U of U's part of the study. "We need to be certain that any benefits of the drug outweigh the risks."
Participants in the study must have suffered blunt or penetrating trauma with significant risk for bleeding. In Utah, the U of U's AirMed medical transport program will enroll participants at accident scenes or in other situations that require helicopter transport of an injured party to the hospital. AirMed crewmembers will administer either tranexamic acid or a placebo while the patient is flown to University of Utah Hospital. Neither patients nor AirMed crewmembers will know whether a person receives tranexamic acid or a placebo.
Because patients who suffer severe trauma are likely to be unable to consent to participate in the trial, the study will be conducted under a federally authorized exception from the informed consent process. This means patients transported by AirMed automatically will be enrolled unless they are wearing a bracelet that says they do not want to take part in the trial. To receive a bracelet and opt out of the trial beforehand, people can call (801) 587-9367 or email staamp@hsc.utah.edu.
The University of Utah Institutional Review Board approved the U of U's participation in the trial, officially called the Study of Tranexamic acid during Air Medical Prehospital transport (STAAMP). For more information about the trial and tranexamic acid go to healthcare.utah.edu/staamp.