Safety and efficacy of intravenous or topical tranexamic acid administration in surgery: a protocol for a systematic review and network meta-analysis.

INTRODUCTION

Tranexamic acid (TXA) has become a widely used antifibrinolytic drug for reducing bleeding in surgery. However, adverse events, such as seizures, pulmonary embolism and deep vein thrombosis, limit its application. To date, insufficient attention has been devoted to determining the optimal dosage and administration route of TXA in the field of surgery. Thus, this study uses the network meta-analysis method, relying on its characteristics of combining direct comparison and indirect comparison, to analyse the safety and efficacy of different doses (high, medium, low) of intravenous injection or of topical application of TXA.

METHODS AND ANALYSIS

We will search the PubMed, Cochrane Central Register of Controlled Trials, Embase, Web of Science and China National Knowledge Internet databases using a strategy that combines the terms TXA, randomised controlled trials and embolism (or haemorrhage, blood transfusion, seizure, mortality). Two reviewers will independently screen all identified abstracts for eligibility and evaluate the risk-of-bias of the included studies using the Cochrane risk of bias tool for randomised controlled studies. We will conduct a systematic review and network meta-analysis. We plan to investigate heterogeneity by performing subgroup analysis and sensitivity analysis, and we will also consider the dose-response relationship between the optimal dose and a better routine. We will assess the overall certainty of the evidence for each outcome using the Grading Recommendations Assessment, Development and Evaluation approach ETHICS AND DISSEMINATION: No ethics approval will be sought, as no original data will be collected for this review. Findings will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO REGISTRATION NUMBER

CRD42021281206.