Impact of Intravenous Tranexamic Acid on Hemorrhage During Endoscopic Sinus Surgery

Original Article Iranian Journal of Otorhinolaryngology, Vol.27(5), Serial No.82, Sep 2015 Impact of Intravenous Tranexamic Acid on Hemorrhage During Endoscopic Sinus Surgery Saeedollah Nuhi1,*Ali Goljanian Tabrizi1, Leyla Zarkhah1, Bahram Rashedi Ashrafi1 Abstract Introduction: Endoscopic sinus surgery is a common procedure performed by otolaryngologists. This study evaluated the efficacy of intravenous (IV) tranexamic acid (TA) on hemorrhage in patients undergoing elective endoscopic sinus surgery (ESS). Materials and Methods: The present study was performed in 170 patients scheduled for ESS surgery under general anesthesia in order to examine the effects of IV TA on providing a bloodless surgical field and to evaluate the amount of bleeding. One hundred patients received intravenous TA and 70 patients received placebo. Intraoperative hemorrhage was estimated by the attending anesthesiologist at the end of surgery by accounting for loss of blood and irrigation fluid in a 25 mL-graded suction canister and nasopharyngeal packing (measured weight of packing on the electronic scale). Hemodynamic variables were monitored and coagulation profile was determined. Results: A total of 170 patients (90 male [53%] and 80 female [47%]), mean age 30.54±4.14 years, were evaluated. There was a significantly lower bleeding volume in the TA group than in the placebo group (107.7±45.1 vs. 189.3±51 mL; P<0.001). There was no significant difference between preand postoperative hematocrit (38.81± 4.20 vs. 36.60± 3.35) or pre- and postoperative hemoglobin (12.51± 2.5 vs. 11.64±1.9) levels in the TA group (P>0.05). Moreover, the difference between the TA and control groups regarding postoperative hematocrit (34.65±4.45 vs. 36.60±3.35) and hemoglobin (10.81±2.1vs. 11.64±1.9) levels was not significant (P>0.05). Vomiting and nausea in the control group was greater than in the control group, but the difference was not significant (P>0.05). We did not detect significant coagulation alterations in the TA group. Conclusion: TA significantly decreased hemorrhage without increasing side effects such as alteration in coagulation parameters, hemodynamic changes, and vomiting and nausea. Use of TA can avoid the need for antihypertensive agents to reduce blood loss in ESS. Keywords: Endoscopic sinus surgery, Hemorrhage, Tranexamic acid. Received date: 28 May 2014 Accepted date: 30 Agu 2014 1 Department of Otorhinolaryngology, Shahid Beheshti University of Medical Sciences, Taleghani Hospital, Tehran, Iran. * Corresponding Author: Department of Otorhinolaryngology, Shahid Beheshti University of Medical Sciences, Taleghani Hospital, Tehran, Iran. Tel:+98-9121437540, Fax:+98-21-22432570, E-mail: 349 Goljanian Tabrizi A, et al Introduction Endoscopic sinus surgery (ESS) is the most common procedure performed by otolaryngologists, because of its high success rate, low incidence of complications, advances in instrumentation and imaging, and the introduction of computer-aided surgery (1,2). However,hemorrhage during and following ESS is an issue of concern for surgeons, and reduction of hemorrhage is an important challenge (3). Earlier studies have confirmed the favorable effects of tranexamic acid (TA), on bleeding tendency in patients undergoing surgery (4,5). Techniques such as bipolar diathermy, packing, topical vasoconstrictors, and induced hypotension have been used to improve the surgical field in ESS; however a number of complications are associated with these methods. For example, diathermy can cause local tissue damage and subsequent bleeding, and topical vasoconstrictors can cause hemodynamic instability, especially in patients with a history of hypertension or ischemic heart disease. Furthermore, induced hypotension exposes patients to more anesthetic drugs and their associated side effects. In addition, none of these drugs consistently provides a desirable bloodless field for surgeons (6–8). TA is an antifibrinolytic agent that blocks lysine binding sites on plasminogen, thereby inhibiting the interaction of plasminogen and the heavy chain of plasmin with lysine residues on the surface of fibrin (9). Some studies have reported the efficacy of topical and oral forms of TA in achieving hemostasis and improving the surgical field in nasal surgery including functional endoscopic sinus surgery (FESS) (10,11). Furthermore, Senghore and Harris revealed that intravenous (IV) administration of TA is effective in preventing excessive postoperative bleeding in healthy adult patients undergoing dental surgery (12). In this study,the efficacy of IV TA in reducing bleeding associated with nasal surgery (i.e; FESS) was examined. Materials and Methods In this controlled, double-blind clinical trial, 170 patients scheduled for elective ESS because of chronic sinusitis were enrolled from 2009 to 2011.The study protocol was approved by the Shahid Beheshti University of Medical Sciences Ethics Committee. Furthermore, the study procedure was explained to all patients, and written, informed consent was obtained. The exclusion criteria were presence of clinically significant conditions such as anemia, end stage renal failure, myocardial ischemia, cerebrovascular thrombosis, ongoing anticoagulant therapy or presence of a bleeding diathesis or history of thrombotic events. Randomization was performed using sequential numbers. The case group (n=100) received IV TA (15 mg/kg) and the control group (n=70) received normal saline in identical syringes. Both participants and study staff (site investigators and trial coordinating center staff) were blinded to treatment allocation. Intraoperative hemorrhage was estimated by the attending anesthesiologist at the end of surgery by accounting for loss of blood and irrigation fluid in a 25-mL-graded suction canister and nasopharyngeal packing (measured weight of packing on the electronic scale). Moreover, at the end of a surgery, the surgical field was graded in terms of bleeding by the surgeon. Hemodynamic parameters, including systolic and diastolic arterial blood pressure (BP), and heart rate (HR) were recorded at 15-minute intervals. Prothrombin time, partial thromboplastin time, and complete blood count were measured before surgery and 6 hours postoperatively. The occurrence of possible side effects of treatment such as nausea, vomiting, pain and epistaxis were evaluated in the post-anesthesia care unit 350 Iranian Journal of Otorhinolaryngology, Vol.27(4), Serial No.81, Jul 2015 The Impact of Tranexamic Acid (TA) on Blood Loss (PACU). Moreover, pain after surgery was measured on a visual analog scale (VAS). Statistical analysis Data are presented as means (standard deviation), medians (ranges), or percentages, as appropriate. Baseline characteristics of the two groups were analyzed using Student's t-test for continuous data and the Chi-square test for categorical analysis. Repeated measures of BP and HR were analyzed using repeated measures analysis of variance (A (...truncated)