Role of prophylactic tranexamic acid instillation in reducing the severity of bleeding during endobronchial biopsy: a double-blind randomized controlled trial

Introduction - Flexible bronchoscopy is one of the most commonly performed procedure, both diagnostic and therapeutic, in pulmonology [3]. Bleeding is a common occurrence following endobronchial biopsy [4]. Post-biopsy bleeding can hamper further bronchoscopic examination, reduce the diagnostic yield of the procedure and can pose serious complications. Tranexamic acid has been demonstrated to have an efficacy equivalent to adrenaline in controlling significant post-biopsy endobronchial bleeding. As a prophylactic agent, tranexamic acid has demonstrated benefit in preventing significant bleeding prior to performing transbronchial lung biopsy. It’s effect in EBBx is not yet studied which is the aim of our study. Methods - Study design : Multicenter blinded randomized controlled trial Study participants : All patients aged > 18 years requiring diagnostic endobronchial biopsy using flexible bronchoscopy. Patients with a visible endobronchial lesion in the form of endobronchial growth, infiltration or nodularity will be randomized to receive either prophylactic tranexamic acid or normal saline according to randomization sequence. Statistical analysis- Microsoft Excel will be used to tabulate data and calculate frequencies and percentages. Baseline characteristics will be assessed as counts and percentages for categorical variables, and as standard measures (median and interquartile range) for continuous variables. STATA software will be used to calculate summary statistics as well to perform χ2 tests, t tests, and Mann-Whitney U tests as appropriate. P values of < .05 will be considered statistically significant. Discussion- Prophylactic tranexamic Acid instillation has been first studied in reduction of bleeding [12]. Post biopsy tranexamic acid instillation and in several TBLB prebiopsy it is shown to reduce bleeding thereby minimizing complication and also increasing yield of procedure [11]. This is first of a kind study to demonstrate the effect for same.