Salt Lake City, UT -- (ReleaseWire) -- 12/03/2019 --University of Utah Health and Intermountain Primary Children's Hospital are jointly participating in the nation's first-ever pediatric multi-center clinical trial of a medication to determine if it is effective in stopping bleeding in children who experience severe traumatic injuries.
The medication, tranexamic acid (TXA), has been shown to reduce deaths in severely injured adults. TXA has previously been used in children with severe injuries at hospitals worldwide, including at Primary Children's Hospital, and is safe. However, its effectiveness has not been clinically studied in children with severe injuries.
The study is funded by the National Heart, Lung and Blood Institute, which is part of the National Institutes of Health (NIH).
Tranexamic acid was made in 1962 by Japanese researchers. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system for adult patients.
Researchers in the new multi-center clinical trial, called TIC-TOC (Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children), want to determine how effectively TXA works in stopping bleeding in severely injured children. Bleeding is a significant issue in severely injured children and can lead to an increased risk of death and disability.
"We already know that TXA is a safe medication to use in children with traumatic injuries," said Dr. Hilary Hewes, the site's primary investigator from University of Utah Health and Primary Children's Hospital. "What we hope the study can tell us is how effective TXA is in children to stop bleeding, and at what dose TXA is the most effective in children."
Parents or guardians who do not want their children to potentially participate in the research trial, which is expected to begin in late summer, can take steps now to opt out by having their name placed on an opt-out list. When a child identified on the opt-out list arrives at a participating hospital, the researchers will know not to enroll that child in the research trial.
TXA is most effective within three hours of injury. Therefore, it is best administered early on in an emergency, which may be before there is an opportunity to gain permission from parents or guardians. For this reason, the research trial has received a federally-authorized exception from the normal informed consent process.
"This means University of Utah Health and Primary Children's Hospital have received FDA permission to administer the potentially life-saving medication, and gain consent from a child's parent or guardian afterward," said Dr. Hewes.
When the research trial begins, severely injured children transported to Primary Children's emergency department for care, and who meet the study criteria, will be automatically enrolled in the study and given TXA or a placebo, unless they are on the opt-out list.
For more information, go to tictoctrial.org or e-mail PEMResearch@hsc.utah.edu to learn more about the research trial and ways to opt out. Information about the study, along with surveys to collect opinions about the research, and ways to opt out have been presented at public meetings held throughout the Wasatch Front this year.
TIC-TOC is a research trial conducted by the Pediatric Emergency Care Applied Research Network (PECARN). The research trial includes participants at UC Davis, Nationwide, and Children's Hospital of Philadelphia.
Primary Children's, which is part of the Intermountain Healthcare system, is the pediatric teaching hospital for the University of Utah School of Medicine.
