Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial
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 childre...
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| Format: | Article |
| Language: | English |
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BMC
2018-10-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2974-z |
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| author | 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 |
| author_facet | 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 |
| author_sort | Daniel K. Nishijima |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-10T05:25:04Z |
| format | Article |
| id | doaj.art-12d1774479224196bcdc876c61fa12e0 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T05:25:04Z |
| publishDate | 2018-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-12d1774479224196bcdc876c61fa12e02022-12-22T02:00:42ZengBMCTrials1745-62152018-10-0119111010.1186/s13063-018-2974-zTraumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trialDaniel K. Nishijima0John VanBuren1Hilary A. Hewes2Sage R. Myers3Rachel M. Stanley4P. David Adelson5Sarah E. Barnhard6Matthew Bobinski7Simona Ghetti8James F. Holmes9Ian Roberts10Walton O. Schalick11Nam K. Tran12Leah S. Tzimenatos13J. Michael Dean14Nathan Kuppermann15for the TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research NetworkDepartment of Emergency Medicine, UC Davis School of MedicineDepartment of Pediatrics, University of Utah School of MedicineDepartment of Pediatrics, Division of Pediatric Emergency Medicine, University of Utah School of Medicine, Primary Children’s HospitalDepartment of Pediatrics, Division of Pediatric Emergency Medicine, Perelman School of Medicine at the University of Pennsylvania, Children’s Hospital of PhiladelphiaDepartment of Pediatrics, Division of Pediatric Emergency Medicine, Ohio State University School of Medicine, Nationwide Children’s HospitalDepartment of Pediatric Neurosciences, Barrow Neurological Institute at Phoenix Children’s HospitalDepartment of Pathology and Laboratory Medicine, UC Davis School of MedicineDepartment of Radiology, UC Davis School of MedicineDepartment of Psychology, University of California, DavisDepartment of Emergency Medicine, UC Davis School of MedicineDepartment of Population Health, London School of Hygiene and Tropical MedicineDepartment of Orthopedics and Rehabilitation, University of WisconsinDepartment of Pathology and Laboratory Medicine, University of California, DavisDepartment of Emergency Medicine, UC Davis School of MedicineDepartment of Pediatrics, University of Utah School of MedicineDepartments of Emergency Medicine and Pediatrics, UC Davis School of MedicineAbstract 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.http://link.springer.com/article/10.1186/s13063-018-2974-zChildrenTraumaTranexamic acid |
| spellingShingle | 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 Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial Trials Children Trauma Tranexamic acid |
| title | Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial |
| title_full | Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial |
| title_fullStr | Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial |
| title_full_unstemmed | Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial |
| title_short | Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial |
| title_sort | traumatic injury clinical trial evaluating tranexamic acid in children tic toc study protocol for a pilot randomized controlled trial |
| topic | Children Trauma Tranexamic acid |
| url | http://link.springer.com/article/10.1186/s13063-018-2974-z |
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