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1.
The effect of the use of tranexamic acid in percutaneous nephrolithotomy on blood loss and surgical visual clarity: a prospective, randomized, controlled and double-blind study
Caliskan, B., Sinan, H., Çağlar, U., Şen, Ö, Akbulut, M. F.
Urolithiasis. 2024;52(1):20
Abstract
Tranexamic acid, once a randomly used antifibrinolytic agent, has been in standard protocols for many specific surgeries. Studies are still needed to standardize the dose and route of tranexamic acid administration, examine its possible contributions in urological surgery, and establish a protocol for its use. To contribute to this goal, we designed a prospective, randomized, double-blind study on 75 patients with 1 control and 2 study groups (n = 25) who underwent percutaneous nephrolithotomy. Group Tranexamic acid received 10 mg/kg intravenous tranexamic acid preoperatively. And Group Irrigation received the same amount in the initial irrigation fluid. Primarily, we observed the total amount of blood transfusion and the changes in hemoglobin and hematocrit values during 2 postoperative days. Distinctively, we intraoperatively monitored hemoglobin continuously as a saturation hemoglobin value to assess the timing of the effect of tranexamic acid. Secondarily, we questioned surgical visual clarity with a standard visual score to reveal its contribution to surgical practicality, operative time, and residual fragment quantity. Our results revealed a significant difference in the reduction of hemoglobin and hematocrit change and blood transfusion in both tranexamic acid groups concerning control, especially on the second day (p = 0.003, p = 0.002, p = 0.001). Likewise, surgical visual scores were significantly better in both tranexamic acid groups (p = 0.018). In conclusion, intravenous or local administration of tranexamic acid at a dose of 10 mg/kg will be sufficient to maintain perioperative stability in hemoglobin values, use fewer blood products and provide a better visual advantage for the surgeon intraoperatively.The trial registration number is NCT05947435, and the date of registration is 07/07/2023, retrospectively registered.
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2.
Precise Application of Topical Tranexamic Acid to Enhance Endoscopic Hemostasis for Peptic Ulcer Bleeding: A Randomized Controlled Study
Chiang, H. C., Chen, P. J., Yang, E. H., Hsieh, M. T., Shih, I. C., Cheng, H. C., Chang, W. L., Chen, W. Y., Chiu, H. C., Kuo, H. Y., et al
Gastrointestinal endoscopy. 2023
Abstract
BACKGROUND AND AIMS Peptic ulcer rebleeding occurs in 20% to 30% of patients after standard endoscopic hemostasis, particularly within 4 days after the procedure. The application of additional tranexamic acid (TXA) to the ulcer may enhance hemostasis. This study investigated the effectiveness of TXA powder application on bleeding ulcers during endoscopic hemostasis. METHODS This study enrolled patients who had peptic ulcer bleeding between March 2022 and February 2023. After undergoing standard endoscopic therapy, the patients were randomly assigned to either a TXA group or standard group. In the TXA group, an additional 1.25 g of TXA powder was sprayed endoscopically on the ulcer. Both groups then received 3 days of high-dose, (8 mg/h) continuous infusion proton-pump inhibitor therapy. Second-look endoscopy was conducted on days 3 to 4. The primary endpoint of early treatment failure was defined as ulcer rebleeding within 4 days or major stigmata of recent hemorrhage on the second-look endoscopy. RESULTS Sixty patients (30 in each group) with peptic ulcer bleeding and balanced baseline characteristics were randomly assigned to treatment groups. The early treatment failure rate was lower in the TXA group (6.7%) than in the standard group (30%) (P = .042). The freedom from treatment failure periods for 4 and 28 days were significantly longer in the TXA group than in the standard group (P = .023). No adverse events from TXA were recorded. CONCLUSION The precise delivery of topical TXA alongside standard endoscopic hemostasis reduced the early treatment failure rate in patients with bleeding peptic ulcers.
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3.
Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial
t Hart, J. W. H., Noordman, B. J., Wijnand, J. M. A., Biter, L. U., Verbrugge, S. J. C., Birnie, E., Dunkelgrun, M., Huisbrink, J., Apers, J. A.
Surgical endoscopy. 2023;37(10):7455-7463
Abstract
INTRODUCTION In metabolic surgery, hemorrhage is the most common major complication. This study investigated whether peroperative administration of tranexamic acid (TXA) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy (SG). METHODS In this double-blind randomized controlled trial, patients undergoing primary SG in a high-volume bariatric hospital were randomized (1:1) to receive 1500-mg TXA or placebo peroperatively. Primary outcome measure was peroperative staple line reinforcement using hemostatic clips. Secondary outcome measures were peroperative fibrin sealant use and blood loss, postoperative hemoglobin, heart rate, pain, major and minor complications, length of hospital stay (LOS), side effects of TXA (i.e., venous thrombotic event (VTE)) and mortality. RESULTS In total, 101 patients were analyzed and received TXA (n = 49) or placebo (n = 52). There was no statistically significant difference in hemostatic clip devices used in both groups (69% versus 83%, p = 0.161). TXA administration showed significant positive changes in hemoglobin levels (millimoles per Liter; 0.55 versus 0.80, p = 0.013), in heart rate (beats per minute; -4.6 versus 2.5; p = 0.013), in minor complications (Clavien-Dindo ≤ 2, 2.0% versus 17.3%, p = 0.016), and in mean LOS (hours; 30.8 versus 36.7, p = 0.013). One patient in the placebo-group underwent radiological intervention for postoperative hemorrhage. No VTE or mortality was reported. CONCLUSION This study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of TXA. However, TXA seems to have positive effects on clinical parameters, minor complications, and LOS in patients undergoing SG, without increasing the risk of VTE. Larger studies are needed to investigate the effect of TXA on postoperative major complications.
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4.
Effect of Tranexamic Acid on Postoperative Bleeding in Sleeve Gastrectomy: a Randomized Trial
Sermet, M., Ozsoy, M. S.
Obesity surgery. 2023
Abstract
PURPOSE Research on the timing and efficacy of tranexamic acid (TXA) use for perioperative bleeding in bariatric surgery is lacking. To evaluate the effects of TXA use on clinical outcomes in laparoscopic sleeve gastrectomy (LSG) by comparing TXA use at the beginning of induction with TXA use at the end of surgery and placebo use. MATERIALS AND METHODS Between February 2022 and August 2022, 177 patients were randomized into three groups: TXA administered at the beginning of induction (TXAI), TXA administered at the end of surgery (TXAP), and placebo groups. Preoperative and postoperative care was standardized, and all patients received LSG. Analyzed using ANOVA, Mann-Whitney U test, and Student's t-test. RESULTS No significant difference was observed between the groups in terms of operative time and blood loss. There were significantly fewer intraoperative bleeding points in the TXAI group compared to the other groups (P < 0.05). Postoperative bleeding was significantly lower in the TXAI and TXAP groups compared to the placebo group (P < 0.05). Hemoglobin and CRP levels showed significant differences between the groups. TXA administration did not cause a significant decrease in coagulation values, and there were no cases of venous thromboembolism (VTE) during the follow-up period. CONCLUSION This study provides evidence that TXA administered during LSG is effective in reducing postoperative bleeding. No data were obtained regarding the superiority of TXA administration at the beginning of induction and at the end of surgery. TRIAL REGISTRATION ClinicalTrials.gov with the registration code NCT05696951, 25 January 2023: https://www. CLINICALTRIALS gov/study/NCT05696951 .
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5.
Evaluation of efficacy and safety of a single dose Tranexamic acid in reducing blood loss during colorectal cancer surgery. A randomised, placebo controlled, double-blinded study
Shaker EH, Fayek ES, Elrawas MM
Indian journal of anaesthesia. 2023;67(2):194-200
Abstract
BACKGROUND AND AIMS Colorectal cancer surgeries are commonly performed nowadays. They are considered as extensive procedures requiring perioperative blood transfusion in 32% to 68% of cases. The objective of this study was to evaluate the anti-haemorrhagic effects and safety of a single dose of tranexamic acid in such surgeries. METHODS Sixty patients scheduled for colorectal cancer surgeries were randomly assigned (TA) into two equal groups. Group TA received 10 mg/kg tranexamic acid in 100 ml of 0.9% NaCl immediately following induction of anaesthesia and control group received 100 ml 0.9% NaCl. The primary outcome was total blood loss reduction. The secondary outcomes were total number of patients requiring blood transfusion and occurrence of any thromboembolic events within 30 days after surgery. RESULTS Intraoperative and total blood loss were lower in TA group compared to the control group (P = 0.010, 0.003, respectively) while postoperative blood loss was comparable between both groups. The need for blood transfusion was lower in TA group (P = 0.038). Number of blood units transfused was also lower in TA group. Mean arterial blood pressure, serum creatinine and urine output in first 24 h postoperatively were comparable between both groups. Haemoglobin level in the first postoperative day was higher in TA group (P = 0.002), but was comparable between the groups at 2 weeks preoperative and from second up to fifth day postoperatively. CONCLUSION A single dose of TA administered between induction and start of surgical procedure may reduce total blood loss and need of transfusion in colorectal cancer surgeries without any serious adverse effects.
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6.
Intravenous Tranexamic Acid in Percutaneous Kidney Biopsy: A Randomized Controlled Trial
Izawa J, Matsuzaki K, Raita Y, Uehara G, Nishioka N, Yano H, Sudo K, Katsuren M, Ohigashi T, Sozu T, et al
Nephron. 2022;:1-8
Abstract
BACKGROUND Tranexamic acid is frequently reported to reduce bleeding-related complications in major surgery and trauma. We aimed to investigate whether tranexamic acid reduced hematoma size after percutaneous kidney biopsy. METHODS We conducted a double-blind, parallel three-group, randomized placebo-controlled trial at a teaching hospital in Japan between January 2016 and July 2018. Adult patients with clinical indication for ultrasound-guided percutaneous biopsy of a native kidney were included. Participants were randomly assigned into three groups: high-dose tranexamic acid (1,000 mg in total), low-dose tranexamic acid (500 mg in total), or placebo (counterpart saline). Intervention drugs were intravenously administered twice, as a bolus just before the biopsy and as a continuous infusion initiated just after the biopsy. Primary outcome was post-biopsy perirenal hematoma size as measured by ultrasound on the morning after the biopsy. RESULTS We assessed 90 adult patients for study eligibility, of whom 56 were randomly allocated into the three groups: 20 for high-dose tranexamic acid, 19 for low-dose tranexamic acid, and 17 for placebo. The median size of perirenal hematoma was 200 mm2 (interquartile range, 21-650) in the high-dose tranexamic acid group, 52 mm2 (0-139) in the low-dose tranexamic acid group, and 0 mm2 (0-339) in the placebo group (p = 0.048 for high-dose tranexamic acid vs. placebo). CONCLUSION In this trial, the median size of post-kidney biopsy hematoma was unexpectedly larger in the high-dose tranexamic acid group than in the placebo group. Although our results do not support the routine use of tranexamic acid in percutaneous kidney biopsy at present, further studies are needed to confirm the results.
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7.
Tranexamic acid and blood loss in pancreaticoduodenectomy: TAC-PD randomized clinical trial
Ishii K, Yokoyama Y, Yonekawa Y, Hayashi D, Kinoshita F, Kuwatsuka Y, Okuno M, Natsume S, Minami T, Sugawara G, et al
The British journal of surgery. 2022
Abstract
BACKGROUND Tranexamic acid (TXA) may reduce intraoperative blood loss, but it has not been investigated in pancreaticoduodenectomy (PD). METHODS A pragmatic, multicentre, randomized, blinded, placebo-controlled trial was conducted. Adult patients undergoing planned PD for biliary, duodenal, or pancreatic diseases were randomly assigned to TXA or placebo groups. Patients in the TXA group were administered 1 g TXA before incision, followed by a maintenance infusion of 125 mg/h TXA. Patients in the placebo group were administered the same volume of saline as those in the placebo group. The primary outcome was blood loss during PD. The secondary outcomes included perioperative blood transfusions, operating time, morbidity, and mortality. RESULTS Between September 2019 and May 2021, 218 patients were randomly assigned and underwent surgery (108 in the TXA group and 110 in the placebo group). Mean intraoperative blood loss was 659 ml in the TXA group and 701 ml in the placebo group (mean difference -42 ml, 95 per cent c.i. -191 to 106). Of the 218 patients, 202 received the intervention and underwent PD, and the mean blood loss during PD was 667 ml in the TXA group and 744 ml in the placebo group (mean difference -77 ml, 95 per cent c.i. -226 to 72). The secondary outcomes were comparable between the two groups. CONCLUSION Perioperative TXA use did not reduce blood loss during PD. REGISTRATION NUMBER jRCTs041190062 (https://jrct.niph.go.jp).
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8.
The Effects of Tranexamic Acid on Bleeding Control During and after Percutaneous Nephrolithotomy (PCNL): A Randomized Clinical Trial
Mokhtari MR, Farshid S, Modresi P, Abedi F
Urology journal. 2021;:6505
Abstract
PURPOSE Tranexamic acid is a fibrinolysis suppressor that is used for a variety of bleeding control procedures such as hematuria, surgery bleeding, and trauma caused bleeding. The advantages of using the tranexamic acid are bleeding control and less need for blood transfusion. MATERIALS AND METHODS This double blind clinical trial was conducted on 108 patients in Imam Khomeni Hospital, Urmia, Iran 2013-14. The control and intervention groups consisted of 54 randomly selected participants each. The intervention group received 1gr of intravenous tranexamic acid with initiation of surgery and 500mg orally each 8hrs afterwards up to three days. The control group received placebo capsules containing starch of the same form. RESULTS The mean term of hospitalization in the intervention group was significantly shorter than that of the control group (P<0.001). The difference between the two groups in terms of preoperative hemoglobin was not significant. However, the decrease in postoperative hemoglobin, intraoperative hemoglobin count in washing liquid, and hemoglobin count in the intervention group were significantly different from those of the control group (P<0.001). CONCLUSION The findings showed that tranexamic acid decreased bleeding during PCNL and the need for blood transfusion. It also decreased the hospitalization term.
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Tranexamic acid in patients with complex stones undergoing percutaneous nephrolithotomy: a randomized, double-blinded, placebo-controlled trial
Batagello CA, Vicentini FC, Monga M, Miller AW, Marchini GS, Torricelli FCM, Danilovic A, Coelho RF, Srougi M, Nahas WC, et al
BJU international. 2021
Abstract
OBJECTIVES To assess the efficacy and safety of single-dose tranexamic acid on the blood transfusion rate and outcomes of patients with complex kidney stones who have undergone percutaneous nephrolithotomy (PCNL). MATERIAL AND METHODS In a randomized, double-blinded, placebo-controlled trial, 192 patients with complex kidney stone (Guy's Stone Scores III-IV) were prospectively enrolled and randomized (1:1 ratio) to receive either one dose of tranexamic acid (1 g) or a placebo at the time of anesthetic induction for PCNL. The primary outcome measure was the occurrence rate of perioperative blood transfusion. The secondary outcome measures included blood loss, operative time, stone-free rate (SFR), and complications. ClinicalTrials.gov identifier: NCT02966236. RESULTS The overall risk of receiving a blood transfusion was reduced in the tranexamic acid group (2.2% vs 10.4%, relative risk: 0.21, 95% confidence interval (CI): 0.03-0.76; P = 0.033, number-needed-to-treat: 12). Patients randomized to the tranexamic acid group showed higher immediate and three-month SFR compared with those in the placebo group (29% vs 14.7%, odds ratio [95% CI]: 2.37 [1.15-4.87], P = 0.019, and 46.2% vs 28.1%, odds ratio [95% CI]: 2.20 [1.20-4.02], P = 0.011, respectively). Faster hemoglobin recovery was demonstrated by patients in the tranexamic group (mean, 21.3 days, P = 0.001). No statistical differences were found in operative time and complications between groups. CONCLUSIONS Tranexamic acid administration is safe and reduces the need for blood transfusion by five times in patients with complex kidney stones undergoing PCNL. Moreover, tranexamic acid may contributes to better stone clearance rate and faster hemoglobin recovery without increasing complications. A single dose of tranexamic acid at the time of anesthetic induction could be considered standard clinical practice for patients with complex kidney stones undergoing PCNL.
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10.
The topical application of tranexamic acid to control bleeding in inguinal hernia surgery candidate patients: A randomized controlled trial
Ghaffari Hamedani SMM, Akbari A, Sayaydi S, Zakariaei Z, Moosazadeh M, Boskabadi J, Naserifar M, Kargar Soliemanabad S
Annals of medicine and surgery (2012). 2021;69:102683
Abstract
BACKGROUND AND OBJECTIVES Inguinal hernia surgery is a common procedure, especially for the elderly, who usually use anticoagulants and antiplatelet drugs. In this study, we evaluated the effectiveness of tranexamic acid (TXA) on the complications of inguinal hernia repair in patients using antiplatelets. PATIENTS AND METHODS This study is a randomized controlled trial that was performed during the 2018-2019 years. Forty patients with inguinal hernia and antiplatelet use were enrolled randomly into the two groups. In the intervention group, the patients received two injectable form (500mg/5 mL) of TXA, totally 10 mL as a topical application at the surgical site, and then the patient's surgical site was seen every 8 h for 48 h, and the patient was examined daily for one week. RESULTS The mean length of hospitalization, seroma, hematoma and infection in the two groups were not statistically significant (P > 0.05). However, the duration of surgery in the TXA group was significantly shorter than in the control group (54.85 vs. 68.72 min) (P < 0.001). The mean bleeding during surgery was significantly lower in the TXA group than in the control group (P < 0.001). CONCLUSION The findings of present study indicate that topical TXA has a high ability to control bleeding. As a result, TXA is beneficial in terms of reducing bleeding and increasing the surgeon's satisfaction. Therefore, it is recommended that TXA be prescribed for patients requiring inguinal hernia surgery with a high risk of bleeding.