Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial

Autor: Nishijima, Daniel K, VanBuren, John, Hewes, Hilary A, Myers, Sage R, Stanley, Rachel M, Adelson, P David, Barnhard, Sarah E, Bobinski, Matthew, Ghetti, Simona, Holmes, James F, Roberts, Ian, Schalick, Walton O, Tran, Nam K, Tzimenatos, Leah S, Michael Dean, J, Kuppermann, Nathan, TIC-TOC Collaborators of the Pediatric Emergency Care Applied Re
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Traumatic
Tranexamic acid
Outcome Assessment
Medicine (miscellaneous)
Pilot Projects
Cardiorespiratory Medicine and Haematology
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
Injury - Trauma - (Head and Spine)
law
Brain Injuries
Traumatic
Outcome Assessment
Health Care
Multicenter Studies as Topic
Pharmacology (medical)
030212 general & internal medicine
Child
Children
Randomized Controlled Trials as Topic
Pediatric
lcsh:R5-920
Glasgow Outcome Scale
Torso
Injuries and accidents
Childhood Injury
Antifibrinolytic Agents
3. Good health
Anesthesia
Child
Preschool
6.1 Pharmaceuticals
lcsh:Medicine (General)
Clinical Trials Data Monitoring Committees
medicine.drug
Antifibrinolytic
Physical Injury - Accidents and Adverse Effects
TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network
Adolescent
medicine.drug_class
Clinical Trials and Supportive Activities
Clinical Sciences
Hemorrhage
Traumatic Brain Injury (TBI)
Trauma
Traumatic Hemorrhage
Unintentional Childhood Injury
03 medical and health sciences
Double-Blind Method
Clinical Research
Multicenter trial
General & Internal Medicine
medicine
Humans
Injury - Childhood Injuries
Adverse effect
Preschool
Traumatic Head and Spine Injury
business.industry
Neurosciences
Injury - Unintentional Childhood Injury
Evaluation of treatments and therapeutic interventions
Infant
030208 emergency & critical care medicine
Brain Disorders
Clinical trial
Health Care
Good Health and Well Being
Cardiovascular System & Hematology
Brain Injuries
Injury (total) Accidents/Adverse Effects
business
Injury - Traumatic brain injury
Zdroj: Trials, vol 19, iss 1
Trials
Trials, Vol 19, Iss 1, Pp 1-10 (2018)
ISSN: 1745-6215
Popis: 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. Electronic supplementary material The online version of this article (10.1186/s13063-018-2974-z) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
Externí odkaz: