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

Nishijima, Daniel K.; VanBuren, John M.; Hewes, Hilary A; Myers, Sage; Stanley, Rachel; Adelson, P. David; Barnhard, Sarah; Bobinski, Matthew; Ghetti, Simona; Holmes, James F.; Roberts, Ian; Schalick, Walton O.; Tran, Nam K.; Tzimenatos, Leah; Dean, J. Michael; Kuppermann, Nathan

doi:10.1186/s13063-018-2974-z

Cited by 18 publications

(11 citation statements)

References 42 publications

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“…All-cause mortality was significantly reduced with TXA by 1.5%; the risk of death due to bleeding was significantly reduced by 0.8% and a reduction in bleeding deaths by one third, mainly through preventing exsanguination within the first 24 h [ 489 , 490 ]. Paediatric patients were not included in the CRASH-2 study; however, an ongoing study is investigating the use of TXA in children [ 491 ] and a study in children undergoing craniosynostosis surgery [ 492 , 493 ] administered an initial bolus of 15–30 mg/kg followed by 2−10 mg/kg/h. One retrospective study has suggested that TXA is of no benefit in patients with viscoelastic hyperfibrinolysis [ 494 ] and another found TXA to reduce multiple organ failure and mortality in severely injured shocked patients [ 495 ].…”

Section: Resultsmentioning

confidence: 99%

The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition

et al. 2019

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Background: Severe traumatic injury continues to present challenges to healthcare systems around the world, and post-traumatic bleeding remains a leading cause of potentially preventable death among injured patients. Now in its fifth edition, this document aims to provide guidance on the management of major bleeding and coagulopathy following traumatic injury and encourages adaptation of the guiding principles described here to individual institutional circumstances and resources. Methods: The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004, and the current author group included representatives of six relevant European professional societies. The group applied a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were reexamined and revised based on scientific evidence that has emerged since the previous edition and observed shifts in clinical practice. New recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated. Results: Advances in our understanding of the pathophysiology of post-traumatic coagulopathy have supported improved management strategies, including evidence that early, individualised goal-directed treatment improves the outcome of severely injured patients. The overall organisation of the current guideline has been designed to reflect the clinical decision-making process along the patient pathway in an approximate temporal sequence. Recommendations are grouped behind the rationale for key decision points, which are patient-or problem-oriented rather than related to specific treatment modalities. While these recommendations provide guidance for the diagnosis and treatment of major bleeding and coagulopathy, emerging evidence supports the author group's belief that the greatest outcome improvement can be achieved through education and the establishment of and adherence to local clinical management algorithms. Conclusions: A multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. If incorporated into local practice, these clinical practice guidelines have the potential to ensure a uniform standard of care across Europe and beyond and better outcomes for the severely bleeding trauma patient.

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Section: Resultsmentioning

confidence: 99%

The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition

et al. 2019

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“…Over the study period, there were a total of 48 patients who were identified using the MTP order, 29 (60%) of whom received TXA in the course of their trauma management. The patients were predominantly male (34, 71%) with an overall median (IQR) age of 14 [7][8][9][10][11][12][13][14][15] years. Baseline characteristics between groups were similar (Table 1), except that patients who received TXA were significantly older (median [IQR]: 14 [12][13][14][15][16] vs 11 [4][5][6][7][8][9][10][11][12][13][14], P ¼ .001).…”

Section: Resultsmentioning

confidence: 99%

“…The patients were predominantly male (34, 71%) with an overall median (IQR) age of 14 [7][8][9][10][11][12][13][14][15] years. Baseline characteristics between groups were similar (Table 1), except that patients who received TXA were significantly older (median [IQR]: 14 [12][13][14][15][16] vs 11 [4][5][6][7][8][9][10][11][12][13][14], P ¼ .001). A majority of patients presented with major trauma based on ISS greater than 15, but there was no difference between groups in severity or type of trauma (penetrating vs blunt).…”

Section: Resultsmentioning

confidence: 99%

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Experience in an Urban Level 1 Trauma Center With Tranexamic Acid in Pediatric Trauma: A Retrospective Chart Review

Thomson

Huynh

Drone

et al. 2020

J Intensive Care Med

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Background: Evidence for tranexamic acid (TXA) in the pharmacologic management of trauma is largely derived from data in adults. Guidance on the use of TXA in pediatric patients comes from studies evaluating its use in cardiac and orthopedic surgery. There is minimal data describing TXA safety and efficacy in pediatric trauma. The purpose of this study is to describe the use of TXA in the management of pediatric trauma and to evaluate its efficacy and safety end points. Methods: This retrospective, observational analysis of pediatric trauma admissions at Hennepin County Medical Center from August 2011 to March 2019 compares patients who did and did not receive TXA. The primary end point is survival to hospital discharge. Secondary end points include surgical intervention, transfusion requirements, length of stay, thrombosis, and TXA dose administered. Results: There were 48 patients aged ≤16 years identified for inclusion using a massive transfusion protocol order. Twenty-nine (60%) patients received TXA. Baseline characteristics and results are presented as median (interquartile range) unless otherwise specified, with statistical significance defined as P < .05. Patients receiving TXA were more likely to be older, but there was no difference in injury type or Injury Severity Score at baseline. There was no difference in survival to discharge or thrombosis. Patients who did not receive TXA had numerically more frequent surgical intervention and longer length of stay, but these did not reach significance. Conclusions: TXA was utilized in 60% of pediatric trauma admissions at a single level 1 trauma center, more commonly in older patients. Although limited by observational design, we found patients receiving TXA had no difference in mortality or thrombosis.

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“…1,[6][7][8][9] Its use in pediatrics has been seen with scoliosis repair, congenital heart repair, and craniosynostosis repair, but has also been increasingly reported in pediatric trauma, such as in the Clinical Randomization of an Antifibrinolytic in Significant Hemorrhage (CRASH-2) trial, diffuse alveolar hemorrhage (DAH), and more recently with post-tonsillectomy hemorrhage. [1][2][3][4][5][6][7][8][9][10][11] As a result of broadening use with limited patient numbers actual dosing parameters are not well established, nor is the safety profile when used for these indications.…”

Section: Discussionmentioning

confidence: 99%

Nebulized Tranexamic Acid for Pediatric Post-tonsillectomy Hemorrhage: A Report of Two Cases

Monteilh

Rabon

Mayer-Hirshfeld

et al. 2021

Clinical Practice and Cases in Emergency Medicine

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Introduction: Tranexamic acid (TXA) use in pediatrics to control hemorrhage has gained interest in recent years, but there is limited literature on nebulized TXA especially regarding dosing and adverse effects. Tranexamic acid has anti-fibrinolytic properties via competitive inhibition of plasminogen activation making it a logical approach to promote hemostasis in cases of post-tonsillectomy hemorrhage. Case Report: We describe two cases of post-tonsillectomy hemorrhage managed with nebulized TXA. In both cases, bleeding was stopped after TXA administration. Conclusion: To our knowledge, this is the first case report to describe the use of nebulized TXA without an adjunct pharmacotherapy. Our two cases add additional reportable data on the safety of nebulized TXA and possible effectiveness on post-tonsillectomy hemorrhage.

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

Cited by 18 publications

References 42 publications

The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition

The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition

Experience in an Urban Level 1 Trauma Center With Tranexamic Acid in Pediatric Trauma: A Retrospective Chart Review

Nebulized Tranexamic Acid for Pediatric Post-tonsillectomy Hemorrhage: A Report of Two Cases

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