âââSchool of Medicine researchers at Washington University in St. Louis will evaluate a drug already approved to minimize blood loss in persons with the genetic clotting disorder hemophilia to improve chances for persons with life-threatening bleeding injuries – such as gunshot wounds, automobile crashes and heavy menstrual blood loss.
The clinical trial scheduled to begin in early 2016 and will enroll 150 trauma patients ages 18 and older who are treated in the emergency department at Barnes-Jewish Hospital for life-threatening blood loss.
The medication is tranexamic acid, or TXA, and often is used during cardiac and orthopedic surgeries to prevent excessive bleeding. TXA has been used by the U.S. military to treat gravely wounded soldiers overseas. The drug, also known by the brand names Lysteda and Cyklokapron, increases the strength of blood clots and is shown to save lives in patients with severe bleeding. Researchers want to determine the best dosage and how the drug works in severely injured patients experiencing massive blood loss.
“Improvements in therapies for patients with life-threatening bleeding are desperately needed,” said study co-investigator Philip Spinella, MD, associate professor of pediatrics and director of the university’s Pediatric Critical Care Translational Research Program. “TXA reduces the breakdown of clots that form with bleeding and, as a result, has the potential to reduce bleeding deaths from severe trauma.”
The trial – officially known as the TAMPITI (Tranexamic Acid Mechanisms and Pharmacokinetics In Traumatic Injury) Trial – is funded by a $2.5 million grant from the U.S. Department of Defense and is expected to last 18 months.
TXA must be given within two hours of a patient’s injury. Because critically ill patients may be too severely injured to give consent, the researchers received approval from the Food and Drug Administration, the Department of Defense and Washington University’s Institutional Review Board (IRB) to enroll patients with life-threatening injuries if the patients themselves or legally authorized family members are unable to give consent. The approval was granted under an exception from informed consent for emergency research.
“New, potentially life-saving advances in emergency medicine would remain at a standstill without the federal rule permitting an exception from informed consent for emergency research,” said study co-investigator Grant Bochicchio, MD, chief of acute and critical care surgery and the Harry Edison Professor of Surgery.
People who are living in the St. Louis area who do not want to be enrolled in the trial may opt out by wearing a bracelet that says, “OPT OUT TAMPITI.” To get the free bracelet, patients can visit the TAMPITI Trial website at www.TAMPITI.wustl.edu, call researchers at 314-747-4185 or email tampititrial@wudosis.wustl.edu.
