Effectiveness of prophylactic tranexamic acid versus placebo or no intervention for reducing blood loss in healthy patients undergoing orthognathic surgery: a systematic review protocol.

OBJECTIVE

The objective of this review is to evaluate the effectiveness of perioperative prophylactic tranexamic acid for reducing blood loss in orthognathic surgery in healthy patients.

INTRODUCTION

Orthognathic surgery can cause significant hemorrhage, which requires postoperative blood transfusions. The most widely studied pharmaceutical adjunct for reducing blood loss is tranexamic acid, a synthetic amino acid that reversibly inhibits plasminogen activation. It is widely used and validated in other surgical procedures to limit blood loss; however, it is not a gold standard in orthognathic surgery.

INCLUSION CRITERIA: We will include clinical trials comparing tranexamic acid to appropriate controls. The primary outcomes are intraoperative blood loss, change in hematocrit/hemoglobin level, and need for blood transfusion. Secondary outcomes include operating time, length of hospital stay, and adverse reactions. Studies of patients with pre-existing coagulopathies and those undergoing only minor orthognathic surgery (eg, genioplasty) will be excluded.

METHODS

We will search 3 electronic databases (PubMed, Embase, and Cochrane Library) from database inception. Titles, abstracts, and full-text papers will be assessed against the inclusion criteria by 2 independent reviewers. Risk of bias will be assessed using the Cochrane Risk of Bias 2.0 tool. Data will be extracted by 2 independent reviewers. Meta-analysis will be conducted for all outcomes where appropriate, with weighted mean differences used for intraoperative blood loss, changes in hematocrit/hemoglobin levels, operation time, and length of stay; and risk ratio for transfusion rates and adverse outcomes. Certainty of the evidence will be presented using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42022314403.