Clinic for Lung Diseases Jordanovac, University Hospital Centre Zagreb, Zagreb, Croatia. Clinic for Lung Diseases Jordanovac, University Hospital Centre Zagreb, Zagreb, Croatia. Electronic address: email@example.com. Ruđer Bošković Institute, Zagreb, Croatia. Clinic for Lung Diseases Jordanovac, University Hospital Centre Zagreb, Zagreb, Croatia; University of Zagreb School of Medicine, Zagreb, Croatia.
BACKGROUND The most commonly used topical haemostatic agents during flexible bronchoscopy (FB) are cold saline and adrenaline. Data on usage of other agents such as tranexamic acid (TXA) for this purpose are limited. RESEARCH QUESTION Is TXA effective and safe in controlling iatrogenic bleeding during FB compared to adrenaline? STUDY DESIGN AND METHODS We conducted a cluster-randomized, double blind, single
centre trial in a tertiary teaching hospital. Patients were randomized in weekly clusters to receive up to 3 applications of TXA (100mg, 2ml) or adrenaline (0.2mg, 2ml, 1:10000) following haemostasis failure after 3 applications of cold saline (4°C, 5ml). Crossover was allowed (for up to 3 further applications) before proceeding with other interventions. Bleeding severity was graded by the bronchoscopist using a visual analogue scale (VAS; 1 - very mild, 10 - severe). RESULTS A total of 2033 FB were performed and 130 patients were successfully randomized to adrenaline (N=65) or TXA (N=65), while 12 had to be excluded for protocol violations (2 from the adrenaline and 10 from TXA arm). Bleeding was stopped in 83.1% (54/65) of patients in both groups (p=1). The severity of bleeding and number of applications needed for bleeding control (N) were similar in both groups (adrenaline mean VAS= 4.9±1.3, N=1.8±0.8; TXA mean VAS=5.3±1.4, N=1.8±0.8). Both adrenaline and TXA were more successful in controlling moderate (86.7% and 88.7%) than severe (40% and 58.3%) bleeding (p=0.008 and p=0.012, respectively), and required more applications for severe (3.0±0 and 2.4±0.5) than moderate (1.7±0.8 and 1.7±0.8) bleeding control (p=0.006 and p=0.002, respectively). We observed no drug related adverse events in both groups. INTERPRETATION We found no significant difference between adrenaline and TXA for controlling non-catastrophic iatrogenic endobronchial bleeding after cold saline failure, adding to the body of evidence that TXA can be used safely and effectively during FB. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov; No.: NCT04771923; URL: www. CLINICALTRIALS gov.