Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-17
SponsorDaniel Nishijima, MD, MAS
About this trial
Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children with hemorrhagic brain and/or torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.
Eligibility criteria
Qualifiers
Less than 18 years old AND
age-adjusted hypotension, or
age-adjusted tachycardia despite adequate resuscitation fluids, or
radiographic evidence of internal hemorrhage, or
Disqualifiers
Unable to administer study drug within 3 hours of traumatic event
Known pregnancy
Known ward of the state
Cardiac arrest prior to randomization
Trial design
Treatments tested in this trial
- Tranexamic acid injection
Treatment groups
2,000 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Daniel Nishijima, MD, MAS
Lead sponsor
University of California, Davis
Sponsor institution
Pediatric Emergency Care Applied Research Network
Collaborator
Source ClinicalTrials.gov