U of U Health is one of four national centers evaluating tranexamic acid

University of Utah Health 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 anticlotting agent 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, 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, which is projected to enroll nearly 1,000 patients nationwide over three years.   

Participants in the study must have suffered blunt or penetrating trauma with significant risk for bleeding. In Utah, the U’s AirMed medical transport program will enroll participants at accident scenes or other situations in which someone injured needs to be taken by helicopter to the hospital. AirMed crewmembers will administer either tranexamic acid or a placebo during transport to University of Utah Hospital. Neither patients nor AirMed crewmembers will know whether a person receives tranexamic acid or placebo.

Federally Authorized Exception From Informed Consent Process

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. Those with life-threatening conditions flown on AirMed will be enrolled in a study testing an FDA-approved drug pre-hospital arrival. Patients who don't want to participate can opt out.

The University of Utah Institutional Review Board approved the U’s participation in the trial, officially called the Study of Tranexamic acid during Air Medical Prehospital transport (STAAMP).