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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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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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Is tranexamic acid associated with decreased need for blood transfusion in percutaneous nephrolithotomy: a systematic review and meta-analysis
Prasad, S., Sharma, G., Devana, S. K., Kumar, S., Sharma, S.
Annals of the Royal College of Surgeons of England. 2023;105(2):99-106
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Abstract
INTRODUCTION Bleeding is a common complication after percutaneous nephrolithotomy (PNL) for renal stone disease. Tranexamic acid (TXA) has been found to reduce mortality and blood transfusion in surgical and trauma patients. This review aimed to assess the safety and efficacy of TXA in patients undergoing PNL. METHODS A systematic literature review was performed to recognise all randomised controlled trials (RCTs) comparing the use of TXA in PNL. The primary outcome of the study was to compare the need for blood transfusion with and without TXA. FINDINGS Six RCTs with 1,323 patients were included in this review. Haemoglobin fall was lower in the TXA group compared with the control group, and the need for blood transfusion was reduced by 67% (odds ratio (OR) 0.33, confidence interval (CI) (0.21, 0.52), p<0.00001). However, blood loss was comparable for the two groups (mean difference -116.9, CI (-244.5,10.7) p=0.07). Length of stay and duration of surgery was significantly shorter with TXA. Furthermore, both minor and major complications were lower in the TXA group. Stone-free rate was higher with the TXA group. No thromboembolic complications were noted in the TXA group. CONCLUSIONS TXA is safe and efficacious for PNL with a reduction in need for blood transfusion and without an attending increase in complication rates.
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Tranexamic acid vs placebo and its impact on bleeding, transfusions and stone-free rates in percutaneous nephrolithotomy: a systematic review and meta-analysis
Hinojosa-Gonzalez DE, Flores-Villalba E, Eisner BH, Olvera-Posada D
Central European journal of urology. 2022;75(1):81-89
Abstract
INTRODUCTION Percutaneous nephrolithotomy (PCNL) is the standard of care for the treatment of large renal stones. Bleeding-related complications remain a major concern when performing this procedure. Tranexamic acid (TXA) has recently been studied in both urologic and non-urologic procedures to reduce bleeding, transfusions and complications. MATERIAL AND METHODS In June 2021 a systematic review was conducted following PRISMA guidelines on randomized prospective studies comparing the effects of TXA on bleeding complications during PCNL. Data was analyzed using Review Manager 5.3. RESULTS Eight studies were included with a total 1,201 patients, of which 598 received TXA and 603 received placebo. TXA was associated with less bleeding (decreased change in hemoglobin) -0.79 Hb g/dl [-1.09, -0.65] p <.00001 and decreased transfusion rates (OR 0.31 [0.18, 0.52] p <0.0001). This was also associated with lower complication rates, both minor, major and overall, OR 0.59[0.41, .85] p = 0.005, OR 0.31 [0.17, 0.56] p = 0.0001 and OR 0.40 [0.29, 0.56] p <0.00001 respectively. TXA was also associated with improved stone-free rates as compared with placebo (OR 1.79 [1.23, 2.62] p = 0.003). TXA resulted in shorter operative times (11.51 minutes [-16.25, -6.77] p =.001) and length of stay (-0.74 days [-1.13 -0.34] p = 0.0006). Two pulmonary embolisms were registered in a single study in the TXA group. CONCLUSIONS In this meta-analysis, the use of TXA during PCNL was associated with a statistically significant reduction in the following parameters when compared with placebo: change in hemoglobin, transfusion rates, complication rates, operative time, and length of stay. It was also associated with improvement in stone-free rates. These data should be considered by surgeons performing PCNL.
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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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Safety and efficacy of tranexamic acid in minimizing perioperative bleeding in extrahepatic abdominal surgery: meta-analysis
Koh A, Adiamah A, Gomez D, Sanyal S
BJS open. 2021;5(2)
Abstract
BACKGROUND Perioperative bleeding is associated with increased morbidity and mortality in patients undergoing elective abdominal surgery. The antifibrinolytic agent tranexamic acid (TXA) has been shown to reduce perioperative bleeding and mortality risk in patients with traumatic injuries, but there is a lack of evidence for its use in elective abdominal and pelvic surgery. This meta-analysis of RCTs evaluated the effectiveness and safety of TXA in elective extrahepatic abdominopelvic surgery. METHODS PubMed, Embase, and ClinicalTrial.gov databases were searched to identify relevant RCTs from January 1947 to May 2020. The primary outcome, intraoperative blood loss, and secondary outcomes, need for perioperative blood transfusion, units of blood transfused, thromboembolic events, and mortality, were extracted from included studies. Quantitative pooling of data was based on a random-effects model. RESULTS Some 19 studies reporting on 2205 patients who underwent abdominal, pelvic, gynaecological or urological surgery were included. TXA reduced intraoperative blood loss (mean difference -188.35 (95 per cent c.i. -254.98 to -121.72) ml) and the need for perioperative blood transfusion (odds ratio (OR) 0.43, 95 per cent c.i. 0.28 to 0.65). TXA had no impact on the incidence of thromboembolic events (OR 0.49, 0.18 to 1.35). No adverse drug reactions or in-hospital deaths were reported. CONCLUSION TXA reduces intraoperative blood loss during elective extrahepatic abdominal and pelvic surgery without an increase in complications.
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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.
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Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial
Lancet. 2020;395(10241):1927-1936
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Abstract
BACKGROUND Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. METHODS We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0.9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0.9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and http://clinicaltrials.gov/ ClinicalTrials.gov, NCT01658124. FINDINGS Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49.9%) or matching placebo (6015, 50.1%), of whom 11 952 (99.5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0.99, 95% CI 0.82-1.18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0.7%] of 5952 vs 46 [0.8%] of 5977; 0.92; 0.60 to 1.39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0.8%] of 5952 vs 26 [0.4%] of 5977; RR 1.85; 95% CI 1.15 to 2.98). INTERPRETATION We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial. FUNDING UK National Institute for Health Research Health Technology Assessment Programme.
PICO Summary
Population
Patients with gastrointestinal bleeding enrolled in the HALT-IT trial (n= 12009).
Intervention
Loading dose of tranexamic acid followed by a maintenance dose of tranexamic acid (n= 5994).
Comparison
Placebo: sodium chloride (n= 6015).
Outcome
Death due to bleeding within 5 days of randomisation occurred in (4%) of patients in the tranexamic acid group and in (4%) of patients in the placebo group. Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (0.7%) vs. (0.8%). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (0.8%) vs. (0.4%).
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The efficacy and safety of the tranexamic acid in reducing blood loss and\ transfusion requirements during percutaneous nephrolithotomy: a systematic review\ and meta-analysis of randomized controlled trials
Feng D, Zhang F, Liu S, Han P, Wei W
Minerva Urol Nefrol. 2020
Abstract
INTRODUCTION Percutaneous nephrolithotomy (PCNL) is a minimally invasive approach used for large kidney stones. Although tranexamic acid (TA) has the property of reducing perioperative bleeding, the effect of this drug on PCNL is equivocal. This meta-analysis was conducted to determine the efficacy and safety of TA in preventing hemorrhagic complications, transfusion requirements and other perioperative outcomes during PCNL with available randomized-controlled trials (RCTs). EVIDENCE ACQUISITION We performed a systematic review of the literature according to Cochrane guidelines for studies comparing TA and normal saline. All studies reporting the outcomes of interest were included. The data analysis was completed using the Cochrane Collaboration's software RevMan 5.3. EVIDENCE SYNTHESIS Data from three RCTs on 570 patients were included in the final meta-analysis. Patients receiving TA experienced less blood loss (MD: -0.82; 95%CI: -1.24 to -0.40; p=0.0001), fewer transfusion requirements (OR: 0.40; 95%CI: 0.01-0.76; P=0.005), lower minor complication rate (OR:0.51, 95%CI: 0.32-0.80, p=0.003), fewer major complication rate (OR:0.31, 95%CI: 0.11-0.88, p=0.03), shorter operative time (SMD: -0.39; 95%CI: -0.75 to -0.02;p=0.04) and less length of stay (LOS) (SMD: -0.68; 95%CI: -1.01 to -0.35; p < 0.0001) than their counterparts during PCNL with statistically significant p value and no significant between-study heterogeneity except for LOS and operative time. CONCLUSIONS Our work assessing the use of TA in the clinical management of patients undergoing PCNL indicated promising results. Further well-designed trials are warranted to determine the optimal dose and indications of this drug in practice.
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Effects of Tranexamic Acid on Bleeding and Hemoglobin Levels in Patients with Staghorn Calculi Undergoing Percutaneous Nephrolithotomy: Randomized Controlled Trial
Mohammadi M, Nouri-Mahdavi K, Barzegar A
Iranian journal of medical sciences. 2019;44(6):457-464
Abstract
Background: The incidence of renal hemorrhage during percutaneous nephrolithotomy (PCNL) is high. We sought to evaluate the effects of tranexamic acid (TXA) on bleeding and hemoglobin levels of patients with staghorn calculi treated with PCNL. Methods: In a double-blind clinical trial, 120 patients with staghorn calculi candidated for PCNL in Alzahra Hospital between January 2014 and November 2017, Isfahan, Iran, were classified into two groups in terms of the stone size (>4 cm and <4 cm). The patients in both groups were then randomly assigned to receive either 1 g of TXA intravenously or normal saline. (The generation of random numbers was done by computer.) Thus, there were four groups of 30 patients each. The transfusion rate, the mean volume of blood loss, the operative duration, and the hemoglobin level were compared between the intervention and control groups for each stone-size category. Statistical analysis was performed using SPSS, version 19. The paired and independent t test and the Pearson coefficient correlation were used, and a P value less than 0.05 was considered statistically significant. Results: The mean volume of blood loss was significantly higher in the control group patients than in those receiving TXA, in both stone-size categories (P<0.001). There was no significant difference in the postoperative hemoglobin level between the intervention and control groups, in both stone-size categories (P=0.26 and P=0.10, respectively). In addition, the mean volume of blood loss increased significantly with an increase in the operative duration (P<0.001). Conclusion: TXA reduced the risk of bleeding during and after PCNL and attenuated the drop in the hemoglobin level in the postoperative period. Longer operative procedures were associated with an increase in the bleeding volume. Trial Registration Number: IRCT20180209038673N1.