|Title||Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC): Study Protocol for a Pilot Randomized Controlled Trial|
|Publication Type||Journal Article|
|Year of Publication||2018|
|Authors||Nishijima DK, VanBuren J, Hewes HA, Myers SR, Stanley RM, P Adelson D, Barnhard SE, Bobinski M, Ghetti S, Holmes JF, Roberts I, Schalick WO, Tran NK, Tzimenatos LS, J Dean M, Kuppermann N|
|Corporate Authors||TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network|
|Keywords||Adolescent, Antifibrinolytic Agents, Brain Injuries, Traumatic, Child, Child, Preschool, Clinical Trials Data Monitoring Committees, Double-Blind Method, Hemorrhage, Humans, Infant, Multicenter Studies as Topic, Outcome Assessment, Health Care, Pilot Projects, Randomized Controlled Trials as Topic, Torso, Tranexamic Acid|
BACKGROUND: Trauma is the leading cause of morbidity and mortality in children in the United States. The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage, however, the drug has not been evaluated in a clinical trial in severely injured children. We designed the Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) trial to evaluate the feasibility of conducting a confirmatory clinical trial that evaluates the effects of TXA in children with severe trauma and hemorrhagic injuries.
METHODS: Children with severe trauma and evidence of hemorrhagic torso or brain injuries will be randomized to one of three arms: (1) TXA dose A (15 mg/kg bolus dose over 20 min, followed by 2 mg/kg/hr infusion over 8 h), (2) TXA dose B (30 mg/kg bolus dose over 20 min, followed by 4 mg/kg/hr infusion over 8 h), or (3) placebo. We will use permuted-block randomization by injury type: hemorrhagic brain injury, hemorrhagic torso injury, and combined hemorrhagic brain and torso injury. The trial will be conducted at four pediatric Level I trauma centers. We will collect the following outcome measures: global functioning as measured by the Pediatric Quality of Life (PedsQL) and Pediatric Glasgow Outcome Scale Extended (GOS-E Peds), working memory (digit span test), total amount of blood products transfused in the initial 48 h, intracranial hemorrhage progression at 24 h, coagulation biomarkers, and adverse events (specifically thromboembolic events and seizures).
DISCUSSION: This multicenter trial will provide important preliminary data and assess the feasibility of conducting a confirmatory clinical trial that evaluates the benefits of TXA in children with severe trauma and hemorrhagic injuries to the torso and/or brain.
TRIAL REGISTRATION: ClinicalTrials.gov registration number: NCT02840097 . Registered on 14 July 2016.
|PubMed Central ID||PMC6208101|
|Grant List||R34HL135214 / / National Heart, Lung, and Blood Institute / |
U24TR001597 / / National Center for Advancing Translational Sciences /
U03MC00008 / / Maternal and Child Health Bureau /
U03MC00001 / / Maternal and Child Health Bureau /
U03MC00003 / / Maternal and Child Health Bureau /
U03MC00006 / / Maternal and Child Health Bureau /
U03MC00007 / / Maternal and Child Health Bureau /
U03MC22684 / / Maternal and Child Health Bureau /
U03MC22685 / / Maternal and Child Health Bureau /