Primary Children’s Hospital in Salt Lake City will participate in a study to test a drug used to stop ongoing bleeding in severe trauma patients on children. The drug has been in use since the 1960s but yet has never been tested on children. This Utah-based provider is teaming up with three other providers across the country to test the drug tranexamic acid (TXA) in children in the first study of its kind, funded by the National Institutes of Health (NIH).
The goal of the study, reports Utah’s Deseret News, is to determine how well it helps prevent bleeding in children and to determine if the drug can help prevent the need for blood transfusion as well as if can reduce deaths in injured pediatric patients. Underlying all of the study objectives is the quest for the correct dosage in children.
If a child is admitted into Primary Children’s (or one of the other sites) with severe head or torso injury and signs of ongoing bleeding, they will be randomly chosen to receive either one or two doses of TXA, or a saline placebo. The study team will then follow each patient over the long term by researchers to assess neurologic outcomes; whether they needed a blood transfusion and how long they spent in the hospital and other outcomes measures identified in the study protocol.
Dr. Hilary Hewes, the principal investigator for the Utah-based site, reports that the drug must be administered within three hours of the injury. Doctors have declared that this dug is safe for children; however, its effectiveness has evaded extensive clinical research until now.
What is tranexamic acid?
It is a medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal nosebleeds and heavy menstruation. It is also used for hereditary angioedema. It can be consumed by mouth or injected into a vein. The drug was first made in 1962 by Japanese researchers Shosuke and Utako Okamoto.
Comments on Informed Consent and Context
The Food and Drug Administration has given the hospital permission to conduct the emergency research due in part to the short time frame in which the child needs to receive the drug. That means when the child comes to the hospital without a parent or guardian, the hospital can elect to enroll them in the study without a parent present. When the parent or guardian arrives, they can opt to remove the child from the study if they desire, reports Dr. Hewes. An opt out by the parents can occur in advance as well.
Dr. Hilary Hewes, the principal investigator, Primary Children’s HospitalSource: Deseret