Does intravenous tranexamic acid reduce bleeding during mastoidectomy?

Am J Blood Res 2020;10(3):46-51 www.AJBlood.us /ISSN:2160-1992/AJBR0109975 Original Article Does intravenous tranexamic acid reduce bleeding during mastoidectomy? Samaneh Ziaei1, Saeid Sadeghi Joni2, Reza Shahriar3, Mehran Shahzamani4 DDS, MS. Assistant Professor, Dept. of Dral and Maxillofacial Medicine, Faculty of Dentistry, Sharekord Branch, Shahrekord, Iran; 2Department of Radiology, Razi Hospital, Guilan University of Medical Sciences, Rasht, Iran; 3 School of Medicine, Tehran University of Medical Sciences, Tehran, Iran; 4Department of Surgery, Chamran Heart Center and University Hospital, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran 1 Received February 27, 2020; Accepted April 18, 2020; Epub June 15, 2020; Published June 30, 2020 Abstract: Mastoidectomy is one of the important head and neck surgeries which is mostly performed due to complications of otitis media. This procedure is performed under microscopic surgery and as a result, a clean visual field is required for surgeons. Bleeding is one of the important issues during microscopic surgeries which reduces visualization. In this clinical trial, we aimed to examine effects of tranexamic acid in reducing bleeding during mastoidectomy. Here we investigated 69 patients who were candidates of mastoidectomy. Patients were randomized into two groups. In group 1, patients received tranexamic acid (10 mg/kg) at the beginning of surgeries along with other anesthetic drugs. In group 2, patients received normal saline as placebo with the same volume. Data regarding to bleeding, duration of surgeries, heart rate and blood pressure of patients were collected and analyzed. We indicated that administration of tranexamic acid is associated with significant reduced bleeding and also reduced blood pressure during surgeries (P<0.001). Taken together, we suggest that otolaryngologists should administer tranexamic acid during microscopic surgeries in order to reduce bleeding and provide a better visual field. Keywords: Mastoidectomy, bleeding, tranexamic acid, microscopic surgeries Introduction Mastoidectomy are considered as important surgical procedures for otitis media with complications [1]. Mastoidectomy was introduced as a successful surgical method for drainage after otitis media and its complications [2, 3]. The most important indication for mastoidectomy is cholesteatoma formation [4]. Mastoidectomy could also be performed along with tympanoplasty with is reported to improve ostrich horn function [5, 6]. Mastoid air cells are removed in simple mastoidectomy which is performed under microscopic fields [7]. This procedure requires continuous suctions of blood in surgical field so that the surgeon will have a better visual field [8]. In this regard, different studies have tried to utilize new medical or nonmedical mechanisms of reducing blood loss during surgery. Nowadays, different pre-operation laboratory tests are performed in order to examine patients’ blood and assess its tendency of bleeding through coagulation tests [9]. On the other hand, variable clinical methods and medications have been used in order to reduce bleeding during mastoidectomy. Controlled hypotension using different medications such as nitroglycerin, remifentanil and labetalol has been used in different studies which brought promising results [10-12]. While this methods might also result in some serious complication including: sever bradycardia and reduced perfusions in vital organs (brain, heart, kidneys and etc.) [13]. Furthermore, anesthetic medications might also cause post-operation bleeding. These issues resulted in increased requirements for improving new methods of reducing bleeding during mastoidectomy. Tranexamic acid is known as a useful medication in reducing bleeding in variable situations such as epistaxis, tooth extraction and during rhinoplasty in patients with hemophilia [14, 15]. Studies have also shown that tranexamic acid has better therapeutic results compared to similar medication like aprotinin [16]. Tran- Tranexamic acid and intra-operative bleeding Figure 1. Consort diagram of patients. examic acid has antifibrinolytic characteristics and inhibits transformations of plasminogen into plasmin [17]. It also acts by impacting on fibrin and forming hemostasis. As a result, tranexamic acid might be an appropriate medication in reducing bleeding during surgeries. In a meta-analysis by Ker and colleagues, they had a survey on effects of tranexamic acid in reducing bleeding during different surgeries. They included 129 studies with 10488 patients and indicated that tranexamic acid decreases the need for blood transfusion 33% during surgeries and also decreases bleeding [18]. To the best of our knowledge, no previous study has evaluated effects of tranexamic acid in reducing bleeding during mastoidectomy in Tehran. As a result, we aimed to investigate this issue in the current paper. Methods and material This study is a randomized double-blinded clinical trial performed in 2018 in Imam Khomeini hospital and Ordibehesht clinic in Tehran. The present study was approved ethically by ethical committee of Tehran University of Medical Sciences. Our study population was consisted of all patients who were candidates of mastoidectomy referred to Imam Khomeini hospital and Khordad clinic. We conducted sample size evaluations and 33 patients were calculated in 47 each group. Overall, we included 70 patients in both groups and 35 in each group. Our inclusion criteria were: age between 20-70 and being a candidate for mastoidectomy by decision of an expert otolaryngologist. Our exclusion criteria were: patient’s refusal, having hypertension, previous history of ischemic heart diseases and any allergies to tranexamic acid. It should also be noted that any changes of surgical procedures or medications was considered as an exclusion criteria. All patients signed informed consent and surgical approaches and procedures were explained for each patient. Demographic data of patients including age and sex were collected. All information regarding to past medical history such as diabetes, hypertension, cardiovascular diseases and smoking were also gathered. All patients divided into two groups each containing 35 patients. This procedure was performed using computed randomization. The study was doubleblinded meaning that surgeon, patients and the collector of information were not aware of the groups of patients and medications. Patients underwent mastoidectomy under the same condition. Anesthetic medications were sodium thiopental (5 mg/kg), atracurium (0.5 mg/kg) and fentanyl (2 µg/kg). Anesthetic pro- Am J Blood Res 2020;10(3):46-51 Tranexamic acid and intra-operative bleeding Table 1. Demographic data of patients Group p-value Tranexamic acid Control Age (year) (mean ± SD) 32.87±7.9 33.20±6.25 0.52 Sex (number (%)) Male 20 (58.8) 18 (51.4) 0.74 Female 14 (41.2) 17 (48.6) Variable Table 2. Heart rate of patients du (...truncated)