دورية أكاديمية
Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial
| العنوان: | Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial |
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| المؤلفون: | Daniel K. Nishijima, John VanBuren, Hilary A. Hewes, Sage R. Myers, Rachel M. Stanley, P. David Adelson, Sarah E. Barnhard, Matthew Bobinski, Simona Ghetti, James F. Holmes, Ian Roberts, Walton O. Schalick, Nam K. Tran, Leah S. Tzimenatos, J. Michael Dean, Nathan Kuppermann, for the TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network |
| المصدر: | Trials, Vol 19, Iss 1, Pp 1-10 (2018) |
| بيانات النشر: | BMC, 2018. |
| سنة النشر: | 2018 |
| المجموعة: | LCC:Medicine (General) |
| مصطلحات موضوعية: | Children, Trauma, Tranexamic acid, Medicine (General), R5-920 |
| الوصف: | Abstract 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. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1745-6215 17744792 |
| Relation: | http://link.springer.com/article/10.1186/s13063-018-2974-z; https://doaj.org/toc/1745-6215 |
| DOI: | 10.1186/s13063-018-2974-z |
| URL الوصول: | https://doaj.org/article/12d1774479224196bcdc876c61fa12e0 |
| رقم الأكسشن: | edsdoj.12d1774479224196bcdc876c61fa12e0 |
| قاعدة البيانات: | Directory of Open Access Journals |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 17456215 17744792 |
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| DOI: | 10.1186/s13063-018-2974-z |