Safety and efficacy of tranexamic acid in bleeding paediatric trauma patients: a systematic review protocol

INTRODUCTION: Trauma is the leading cause of death among children aged 1–18. Studies indicate that better control of bleeding could potentially prevent 10–20% of trauma-related deaths. The antifibrinolytic agent tranexamic acid (TxA) has shown promise in haemorrhage control in adult trauma patients. However, information on the potential benefits of TxA in children remains sparse. This review proposes to evaluate the current uses, benefits and adverse effects of TxA in the bleeding paediatric trauma population. METHODS AND ANALYSIS: A structured search of bibliographic databases (eg, MEDLINE, EMBASE, PubMed, CINAHL, Cochrane CENTRAL) has been undertaken to retrieve randomised controlled trials and cohort studies that describe the use of TxA in paediatric trauma patients. To ensure that all relevant data were captured, the search did not contain any restrictions on language or publication time. After deduplication, citations will be screened independently by 2 authors, and selected for inclusion based on prespecified criteria. Data extraction and risk of bias assessment will be performed independently and in duplicate. Meta-analytic methods will be employed wherever appropriate. ETHICS AND DISSEMINATION: This study will not involve primary data collection, and formal ethical approval will therefore not be required. The findings of this study will be disseminated through a peer-reviewed publication and at relevant conference meetings. TRIAL REGISTRATION NUMBER: CRD42016038023.