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The Effect of Topical Tranexamic Acid in Endoscopic Sinus Surgery: A Triple Blind Randomized Clinical Trial
Achour I, Ben Rhaiem Z, Thabet W, Jdidi J, Mnejja M, Hammami B, Chakroun A, Charfeddine I
The Annals of otology, rhinology, and laryngology. 2022;:34894221086086
Abstract
OBJECTIVE Our aim is to evaluate the effect of topical tranexamic acid (TA) on bleeding and surgical quality field in the functional endoscopic sinus surgery (FESS). METHODS A total of 74 patients who underwent FESS due to chronic rhinosinusitis were included. The patients were randomized into 2 groups. TA group (n = 37) received a topical cotton pledget soaked with TA and placebo (PL) group (n = 37) received a pledget soaked with saline solution. RESULTS A significant effect was noted for the TA group versus the PL group in the grade 1 of the Boezaart scale at 35 minutes (4 for TA group and no case for PL group). This effect was absent for higher grades. We did not notice a significant effect between the 2 groups at 5 minutes. Blood loss was 359 ml in the TA group versus 441 ml in the PL group. No significant change was observed between the 2 groups concerning the blood parameters. No side effects were reported. CONCLUSION Despite its safety when administrated locally and its low cost, TA provides limited effect on quality of surgical field after 35 minutes of the start of FESS in the patients with chronic rhinosinusitis. This effect was absent at the start of the intervention and when analyzing the blood loss and hematologic parameters.
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2.
Evaluation of applying topical tranexamic acid to control septorhinoplasy - induced hemorrhage
Habibi AF, Jalali MM, Ashraf A, Hajian A, Nemati S, Ramezani H, Asli RH
American journal of otolaryngology. 2022;43(5):103514
Abstract
OBJECTIVES Hemorrhagic events related to surgical field is a common disturbing complication which could worsen the outcomes of operation. This study aimed to evaluate how applying of topical tranexamic acid (TXA) could affect bleeding related to septorhinoplasty operation. MATERIAL AND METHODS This double-blind controlled trial study finally evaluated 198 candidates for septorhinoplasty repair who were randomly allocated to two groups: TXA receivers (5 mg/kg) and control group (received 5 mg/kg of saline 0.9 %). Then cumulative volume of hemorrhage was calculated by adding total volume of suctioned blood and numbers of fully blood-filled surgical gauzes (15 mL in each). Additionally postoperative 24 h volume of hemorrhage was measured by counting number of bloody surgical gauzes. RESULTS Of all participants, 90 % were female. The mean age was 26 ± 7 years. Total cumulative volume of hemorrhage during surgery was significantly diminished when topical TXA was applied (p < 0.0001). Additionally drier field of operation was illustrated postoperatively in patients received topical TXA (2 % & 28 % in TXA and saline 0.9 % receivers, respectively) (p < 0.001). CONCLUSION Using topical TXA could decrease bleeding volume and make surgical field of septorhinoplasty drier either during surgery or postoperatively.
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3.
Efficacy of topical tranexamic acid to reduce bleeding in endoscopic sinus surgery for chronic rhinosinusitis with polyposis
Husain S, Ramos JA, Karaf JHA, Zahedi FD, Ahmad N, Abdullah B
European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2022
Abstract
PURPOSE To evaluate the efficacy of topical tranexamic acid (TXA) in reducing intraoperative and immediate postoperative bleeding during functional endoscopic sinus surgery (FESS) among patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). METHODS This is a double-blind randomized clinical trial, involving 26 patients with CRSwNP, who underwent FESS for failed medical therapy. The intervention nostril was packed with ribbon gauze soaked in 500 mg/5 ml TXA. The control nostril was packed with ribbon gauze soaked in Moffett's solution, containing 2 ml 10% cocaine, 1 ml adrenaline 1:1000, and 4 ml 0.9% sodium bicarbonate. Both nostrils were packed for 15 min before FESS. Intraoperative bleeding was recorded in the initial 30 min after commencing the surgery. The recordings were reviewed by two surgeons using Boezaart's scoring system. The scores were taken at 15 and 30 min of surgery. The mean score was then calculated. At the end of the surgery, the intervention nostril was packed with Merocel(®) soaked in 500 mg/5 ml TXA and the control nostril was packed with Merocel(®) soaked in normal saline. The amount of bleeding within 24 h post-surgery was evaluated using a bolster gauze. RESULTS There was no significant difference in intraoperative bleeding between the intervention (1.54 ± 0.71) and control nostrils (1.69 ± 0.55) with p = 0.172. The amount of bleeding in the postoperative period was significantly reduced in the intervention nostril (1.33 ± 0.55) compared to the control nostril saline (1.81 ± 0.48) with p = 0.001. CONCLUSIONS We found that the nasal packing soaked in TXA reduced intraoperative and immediate postoperative bleeding. It is a safe, efficacious and cost-effective alternative to Moffett's solution during FESS and also an alternative to normal saline post-surgery among patients with CRSwNP. TRIAL REGISTRATION NUMBER FF-2015-232, 2015.
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Comparison of Tranexamic acid, Remifentanil, and Hydralazine on the bleeding volume during Dacryocystorhinostomy surgery
Moradi Farsani D, Shetabi H, Rafiee Zadeh A, Saffari Rad N
International journal of physiology, pathophysiology and pharmacology. 2022;14(3):177-186
Abstract
BACKGROUND Bleeding in Dacryocystorhinostomy (DRC) limits the surgeon's sight and access. Tranexamic acid, Remifentanil, and Hydralazine reduce intraoperative blood loss. However, no study has been carried out to compare the efficacy of the latter drugs during DCR surgery. METHODS Ninety healthy candidates for DCR surgery with chronic Dacryocystitis (aging 20-80) were randomly assigned in groups of 30 to receive low doses of Tranexamic acid (TXA) (10 mg/kg with a maximum dose of 1000 mg), Remifentanil (0.1 µ/kg), or Hydralazine (0.1 mg/kg). All drugs were infused over 15 minutes before the initiation of surgery. The primary outcome was the bleeding volume during the surgery and until 2 hours in recovery. This study was approved by the Iranian Registry of Clinical Trials with the code of IRCT20210614051574N10 (https://en.irct.ir/trial/62759). RESULTS Thirty patients (mean age ± SD: 50.48±13.4) were investigated. Mean blood loss volume was lower in Remifentanil and Hydralazine groups compared with the TXA group (P<0.05); there was no significant difference (P>0.05) in bleeding volume between Remifentanil and Hydralazine groups (Tranexamic acid group: 146.83±91 ml, Remifentanil group: 77.6±52.1 ml, Hydralazine group: 80.0±48.7 ml, 95% confidence interval, P<0.05). CONCLUSION Our results show that Remifentanil and Hydralazine are more effective than Tranexamic acid in bleeding control.
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Intravenous Tranexamic Acid Improves the Intraoperative Visualization of Endoscopic Sinus Surgery for High-Grade Chronic Rhinosinusitis: A Randomized, Controlled, Double-Blinded Prospective Trial
Yang W, Gou H, Li H, Liu Y, Wan Y, Wang C, Wang G, Zhang L
Frontiers in surgery. 2021;8:771159
Abstract
Objective: Intraoperative bleeding during endoscopic sinus surgery (ESS) for high-grade rhinosinusitis can be serious and can further obscure the surgical field. This study was designed to evaluate the effect of tranexamic acid (TXA) on the surgical visualization of ESS for high-grade rhinosinusitis. Methods: In total, 60 patients with high-grade chronic rhinosinusitis (Lund-Mackay score 12 or greater) treated by ESS were randomized into two groups: the control group (Group C) or the TXA group (Group T). Each group included 30 patients. Patients in Group T received intravenous TXA, and those in Group C received normal saline. The Boezaart grading scale (BS) score was assessed as the primary outcome. Total blood loss (TBL), whole blood coagulation, and fibrinolysis were assessed by Sonoclot analysis, and complications were recorded and compared between the groups. Result: A significant difference was found in the BS score between Group T and Group C [2.02 (1.88-2.05) vs. 2.27 (2.13-2.41), P = 0.011]. Increases in platelet function (PF) and fibrin degradation time (FDT) were assessed during the operation and showed significant differences between Group T and Group C (P = 0.040 for PF; P = 0.010 for FDT). No difference in complications was found between the two groups. Conclusion: A 15 mg/kg bolus of intravenous TXA before surgery can improve the surgical visualization of ESS for high-grade chronic rhinosinusitis without causing significant adverse effects. Intravenous TXA may be beneficial in ESS for high-grade chronic rhinosinusitis. Clinical Trial Registration: https://www.chictr.org.cn/edit.aspx?pid=121653&htm=4.
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Selection of the optimal dosage of tranexamic acid to reduce blood loss during pediatric cleft palate surgery
Shafa A, Shetabi H, Adineh-Mehr L, Bahrami K
Tzu chi medical journal. 2021;33(2):181-187
Abstract
OBJECTIVE The aim of the present study was to evaluate and select the optimal dosage of tranexamic acid (TXA) to reduce blood loss during cleft palate surgery in children. MATERIALS AND METHODS This randomized double-blind clinical trial was performed on 80 children under 3 years of age that were candidates for cleft palate surgery. These children were divided into four groups as follows: the first, second, and third groups received 5, 7.5, and 10 mg/kg of TXA, respectively. Moreover, the fourth group was considered as the control group. Before induction of anesthesia and then every 15 min during the surgery, some parameters such as mean arterial pressure, heart rate, SpO(2), and ETCO(2) were recorded. Moreover, the amount of blood loss during the surgery, the level of surgeon's satisfaction, and incidence rate of complications were assessed and recorded. RESULTS The amount of blood loss during the surgery in TXA groups receiving dosages of 5, 7.5, and 10 mg/kg with the means of 63.75 ± 10.62, 61.25 ± 15.03, and 61.00 ± 14.29, respectively, was significantly lower than that of the control group with the mean of 92.25 ± 19.83 (P < 0.001). Moreover, no significant difference was found between the three groups receiving TXA dosages in terms of the amount of blood loss, the level of surgeon's satisfaction (P > 0.05). CONCLUSION According to the results of the present study, all three dosages of TXA had a significant role in reducing blood loss in cleft palate surgery. Given the potential for increased risk of side effects from the drug, it seems safe to use the minimal dosage of this drug to control and reduce blood loss during cleft palate surgery in children <3 years of age.
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Outcomes of combined use of topical and intravenous tranexamic acid on surgical field quality during functional endoscopic sinus surgery: A randomized controlled trial
El-Ozairy HSE, Mady OM, Tawfik GM, Elhennawy AM, Teaima AA, Ebied A, Huy NT
Head & neck. 2021
Abstract
BACKGROUND Intraoperative bleeding during functional endoscopic sinus surgery (FESS) poses a challenge to both surgeon and anesthetist. The primary aim of this study was to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid (TA) in improving the surgical field quality during FESS. METHODS We conducted a randomized controlled double-blinded prospective trial on 120 patients scheduled for elective FESS. After induction of general anesthesia, patients were randomly and evenly assigned to one of four groups; IV TA, local TA, both IV and local TA, and placebo. Surgical field was assessed using five-point Boezaart scale. Total fentanyl and esmolol consumption, operative time, recovery time, and postoperative complications were recorded. RESULTS Surgical field quality score was the best in IV and local TA group compared to others (p < 0.001). Mean operative time was found significantly shorter in IV and local TA group than placebo one. Total fentanyl consumption was significantly lower in IV and local TA group comparing to others (p = 0.025). Mean recovery time was significantly shorter for IV and local TA group compared to others. Total fentanyl consumption was significantly lower in IV and local TA group comparing to others. No significant differences were found of mean arterial pressure and heart rate decline in four groups. None of the patients in four groups required esmolol administration. No statistically significant differences were found in change of hemoglobin, hematocrit, prothrombin time, and partial thromboplastin time over time in all groups. CONCLUSION The combined use of topical and intravenous TA provided the best surgical field in FESS, less fentanyl consumption, and less recovery time without causing significant side effects.
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The efficacy of Tranexamic Acid Administration in Patients Undergoing Tonsillectomy: An Updated Meta-Analysis
Kuo CC, DeGiovanni JC, Carr MM
The Annals of otology, rhinology, and laryngology. 2021;:34894211045264
Abstract
OBJECTIVE There is controversy regarding the efficacy and safety of tranexamic acid (TXA) in reducing tonsillectomy-related hemorrhage. We conducted a systematic review and meta-analysis to evaluate the prophylactic role of TXA in tonsillectomy. METHODS We searched 6 databases to identify studies that directly compare the effect of TXA versus controls in tonsillectomy patients. Standardized mean difference was applied to summate the findings across the studies. Dichotomous data were expressed as relative risk. RESULTS Ten studies representing a total of 111 898 patients were included. The pooled results showed a significant reduction of intraoperative blood loss by 39.02 ml (SMD = -1.05, 95% CI: -1.91 to -0.20, P = .016) and the rate of post-tonsillectomy hemorrhage (RR = 0.42, 95% CI: 0.28 to 0.65, P < .0001), with no significant difference in reduction of further intervention risk (RR = 0.78, 95% CI: 0.45 to 1.35, P = .373). CONCLUSIONS Overall, this study indicates that TXA may reduce blood loss and frequency of post-operative hemorrhage associated with tonsillectomy. Further large, high-quality clinical trials are still needed to explore TXA's effect on post-tonsillectomy hemorrhage and the safety of its use.
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Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial
Fornazieri MA, Kubo HKL, de Farias LC, da Silva AMF, Garcia ECD, Santos Gald, Pinna FR, Voegels RL
International archives of otorhinolaryngology. 2021;25(4):e557-e562
Abstract
Introduction Intra and postoperative bleeding are the most frequent and feared complications in adenotonsillectomy (AT). Tranexamic acid (TXA), which is known for its antifibrinolytic effects, has a proven benefit in reducing bleeding in hemorrhagic trauma and cardiac surgery; however, the effectiveness and timing of its application in AT have not yet been established. Objectives We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. Methods The present randomized, controlled, double-blind clinical trial included 63 children aged 2 to 12 years. They were randomly assigned to receive either intravenous TXA (10 mg/kg) or placebo 10 minutes before surgery. The volume of intraoperative bleeding, presence of postoperative bleeding, and adverse effects during and 8 hours after the surgery were assessed. Results No difference in bleeding volume was noted between the 2 groups (mean, 122.7 ml in the TXA group versus 115.5 ml in the placebo group, p = 0.36). No intraoperative or postoperative adverse effects were noted because of TXA use. Furthermore, no primary or secondary postoperative bleeding was observed in any of the participants. Conclusion In our pediatric sample, TXA (10 mg/kg) administration before AT was safely used, without any adverse effects. It did not reduce the bleeding volume in children during this type of surgery. Future studies should assess the use of higher doses of TXA and its administration at other time points before or during surgery.
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10.
A randomized parallel design trial of the efficacy and safety of tranexamic acid, dexmedetomidine and nitroglycerin in controlling intraoperative bleeding and improving surgical field quality during septorhinoplasty under general anesthesia
Modir H, Moshiri E, Naseri N, Faraji F, Almasi-Hashiani A
Medical gas research. 2021;11(4):131-137
Abstract
In this blinded clinical trial, we attempted to compare the efficacy and safety of administering tranexamic acid, dexmedetomidine and nitroglycerin in preventing intraoperative bleeding and improving the quality of the surgical field during septorhinoplasty under general anesthesia. A total of 105 patients scheduled for septorhinoplasty were enrolled and randomly assigned into three groups based on the balanced-block randomization method. First group received 1 μg/kg intravenous injection dexmedetomidine, second group received 10 mg/kg intravenous injection tranexamic acid and third group received 0.5 μg/kg nitroglycerin, intravenously. The study sample was composed of 105 participants with the total mean age of 25.85 ± 6.52 years, and 59.05% of participants were female and the mean of body mass index was 24.34 ± 2.57 kg/m(2). The results showed that there was no statistically significant difference in terms of arterial oxygen saturation, mean arterial pressure, heart rate, bleeding rate, duration of surgery, and surgeon satisfaction among the three groups; however, there was a significant difference in the extubation time, recovery time and the dose of administered propofol among the three groups. Dexmedetomidine reduced the dose of administered propofol while increasing the extubation time and recovery time. In the tranexamic acid group compared with the other two groups, the recovery time was shorter. However, all the three drugs could reduce intraoperative bleeding and lead to surgeon satisfaction. It can be concluded that all these three drugs can be utilized to control bleeding and improve the quality of the surgical field but the ultimate decision lies with the anesthesiologist's judgment and the conditions of the patient. The study protocol was registered in the Iranian Registry of Clinical Trials (registration No. IRCT20141209020258N121) on September 24, 2019 and it was ethically approved by the Ethical Committee of Arak University of Medical Sciences (approval No. IR.ARAKMU.REC.1397.355) on February 24, 2019.
