|Age:||-1 to 17 years old|
|Keywords:||Tranexamic Acid, Tranexamic Acid in children, head injury, torso injury, stomach injury, abdominal injury in children, abdominal injury, injury to child, brain injuries|
|Type:||Drug study, Phase 2|
Your child will be assigned one of three different study drug groups through a method called randomization. This means that a computer will decide by chance which group a person is in, not the doctors running the study. In a “randomized trial” people are put in one group or another by random chance, like flipping a coin. In this study, the 3 different groups are:
• Group A (TXA 15 mg/kg bolus over 20 min then 2 mg/kg/hr over 8 hours) • Group B (TXA 30 mg/kg bolus over 20 min then 4 mg/kg/hr over 8 hours) • Group C (Placebo)
The placebo drug is a non-active product made of salt water. A placebo is a dummy treatment that looks like the study drug but is not. Placebos contain no drugs or active ingredients. Study participants are given placebos so that the effects of a drug can be compared against no drug. Use of placebos also prevents the participant and the doctor from knowing whether or not the subject is getting the drug. You will have a one in three chance of being given each study drug. Neither you nor the study doctor will know which study drug you are getting.
Once your child has been randomly assigned to a study group, some of the study drug will be administered immediately through their IV over 20 minutes. This is considered the initial dose (or bolus) and will usually happen in the Emergency Department. After the initial dose has been given, the remaining study drug will be administered through the IV slowly over the next 8 hours.
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.