Trauma is the leading cause of death and disability in children in the United States. Severely injured children often have difficultly stopping their bleeding after trauma, and this leads to an increased risk for death and disability.
Tranexamic Acid (TXA) is a medicine that helps stop bleeding. TXA has been shown to reduce death in severely injured adults. TXA has not been appropriately studied in children with severe injuries.
The purpose of this study is to see how well TXA works in severely injured children. TXA has the potential to help improve the quality of life of injured children.
Children younger than 18 years old who experience a serious injury with significant bleeding inside their bodies or in their brain will be included.
Based on previous research studies involving TXA, it is very unlikely that there will be an increased risk of complications in injured children receiving TXA compared to placebo (saline solution). Theoretically, however, potential side effects of TXA treatment include blood clots, seizures, vomiting, and rashes.
Meetings will be held in the community to provide information, answer questions and get community members’ thoughts and feelings about the study. You can also contact the study team to complete a one-on-one interview about the study.
The TIC-TOC study is being conducted within the Pediatric Emergency Care Applied Research Network (PECARN).
TIC-TOC is funded by the National Institutes of Health, an agency of the federal government. PECARN conducts studies to learn how to improve emergency care for severe injuries and illnesses in children.
The TIC-TOC study will be conducted at 4 children's hospitals:
An injury can happen to anyone at anytime. If you do not wish your child to be enrolled into the TIC-TOC study he/she can be placed on an opt-out list. If you are placed on this list, when you arrive at a participating hospital, the researchers will know not to enroll your child in this study. If you would like to opt-out of the TIC-TOC trial, please contact us below.