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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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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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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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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.
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Reevaluation of the efficacy of tranexamic acid in reducing blood loss in percutaneous nephrolithotomy: a randomized clinical trial
Mohammadi-Sichani M, Kazemi R, Nouri-Mahdavi K, Gholipour F
Minerva Urologica E Nefrologica = the Italian Journal of Urology and Nephrology. 2018
Abstract
BACKGROUND Tranexamic acid was reported to reduce bleeding in patients undergoing percutaneous nephrolithotomy (PCNL). The current study was performed to reevaluate the efficacy and safety of tranexamic acid in reducing PCNL-related blood loss. METHODS A total of 132 consecutive patients were randomized into two groups; the case group received 1 gr of intravenous tranexamic acid before induction, followed by IV infusion of a fixed dose of 1 gr tranexamic acid at 8-hour intervals for the first 48 hours after the procedure, while the control group received normal saline as placebo. Demographic and clinical characteristics of patients were recorded. The collected data were then analyzed using Chi-square, t-test, and multivariate regression analysis with IBM SPSS Statistics software. RESULTS There was no significant difference in demographic characteristics of the two groups. Mean hemoglobin drop was 2.2 +/- 1.5 g/dL in tranexamic acid group and 2.4 +/- 1.5 g/dL in controls (p = 0.312). The blood loss did not show significant different between tranexamic acid and control groups (751 +/- 523 mL vs. 826 +/- 525 mL, p = 0.416). Multivariate analysis has revealed that multiple access tracts is a risk factor for increased blood loss (p = 0.014). CONCLUSIONS Tranexamic acid administration is not associated with significant reduction of PCNL-related blood loss. Our findings are unlike the results of few recent studies, make it necessary for further similar trials to be conducted before widespread use of the drug in patients undergoing PCNL.
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Role of tranexamic acid on blood loss in laparoscopic cholecystectomy
Pandove PK, Singla RL, Mittal P, Mahajan N, Kumar A
Nigerian Journal of Surgery : Official Publication of the Nigerian Surgical Research Society. 2017;23((2)):111-114.
Abstract
CONTEXT Nonsurgical uses of tranexamic acid include the management of bleeding associated with leukemia, ocular bleeding, recurrent hemoptysis, menorrhagia, hereditary angioneurotic edema, and numerous other medical problems. However, there is hardly any documentation of the use of tranexamic acid in laparoscopic cholecystectomy. AIMS This study was conducted to evaluate the role of tranexamic acid in limiting blood loss in laparoscopic cholecystectomy and to evaluate the effect of blood loss on morbidity in terms of hospital stay and mortality of the patient. SUBJECTS AND METHODS The study was conducted on sixty patients admitted with gallstones, candidates for laparoscopic cholecystectomy. Thirty patients received an intravenous 20 mg/kg bolus dose of tranexamic acid at induction of anesthesia (Group A), and another thirty did not receive the aforementioned drug at induction (Group B). STATISTICAL ANALYSIS The two groups were compared, and the data collected were entered and tabulated using Microsoft Office Excel and analyzed using appropriate statistical tests. RESULTS The mean postoperative hospital stay (2.4 vs. 2.63, P = 0.4147), drain fluid hemoglobin (Hb) (0.83 vs. 0.90, P = 0.2087), drain fluid hematocrit (0.2434 vs. 0.2627, P = 0.3787), mean drain output (85 vs. 87.23, P = 0.9271), mean pulse rate at the start of surgery (74.2 vs. 75, P > 0.999), mean pulse rate 24 h after surgery (75.9 vs. 76.4, P = 0.5775), and mean change in Hb (0.240 vs. 0.266, P = 0.2502) in both the groups were not significant. CONCLUSIONS There is no active role of tranexamic acid in elective laparoscopic cholecystectomy.
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Influence of ultra-low dose Aprotinin on thoracic surgical operations: a prospective randomized trial
Apostolakis E, Panagopoulos N, Koletsis EN, Crockett J, Stamou-Kouki H, Sourgiadaki E, Filos K, Dougenis D
Journal of Cardiothoracic Surgery. 2008;3:14
Abstract
BACKGROUND The blood saving effect of aprotinin has been well documented in cardiac surgery. In thoracic surgery, very few recent studies, using rather high doses of aprotinin, have shown a similar result. In a randomized prospective trial, we have tested the influence of aprotinin using an ultra-low dose drug regime. METHODS Fifty-nine patients, mean age 58 +/- 13. 25 years (mean +/- SD) undergoing general thoracic procedures were randomized into placebo (Group A) and treatment group (Group B). The group B (n = 29) received 500. 000 IU of aprotinin after induction to anesthesia and a repeat dose immediately after chest closure. A detailed protocol with several laboratory parameters was recorded. Patients were transfused when perioperative Ht was less than 26%. RESULTS The two groups were similar in terms of age, gender, diagnosis, pathology, co-morbidity and operations performed. The mean drainage of the first and second postoperative day in group B was significantly reduced (412. 6 +/- 199. 2 vs. 764. 3 +/- 213. 9 ml, p < 0. 000, and 248. 3 +/- 178. 5 vs. 455. 0 +/- 274. 6, p < 0. 001). Similarly, the need for fresh frozen plasma transfusion was lower in group B, p < 0. 035. Both the operation time and the hospital stay were also less for group B but without reaching statistical significance (84. 6 +/- 35. 2 vs 101. 2 +/- 52. 45 min. and 5. 8 +/- 1. 6 vs 7. 2 +/- 3. 6 days respectively, p < 0. 064). The overall transfusion rate did not differ significantly. No side effects of aprotinin were noted. CONCLUSION The perioperative ultra-low dose aprotinin administration was associated with a reduction of total blood losses and blood product requirements. We therefore consider the use of aprotinin safe and effective in major thoracic surgery.
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Perioperative parenteral tranexamic acid in liver tumor resection: a prospective randomized trial toward a blood transfusion-free hepatectomy
Wu CC, Ho WM, Cheng SB, Yeh DC, Wen MC, Liu TJ, P'eng FK
Annals of Surgery. 2006;243((2):):173-80.
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Abstract
OBJECTIVE To examine the feasibility of a real blood transfusion-free hepatectomy in a large group of patients with liver tumors. SUMMARY BACKGROUND DATA Bleeding control and blood transfusion remains problematic in liver resection. A real blood transfusion-free hepatectomy in a large group of patients has rarely been reported. The impact of tranexamic acid (TA), an antifibrinolytic agent, on blood transfusion in liver resection is unknown. METHODS A prospective double-blind randomized trial was performed on elective liver tumor resections. In group A, TA 500 mg was intravenously administered just before operation followed by 250 mg, every 6 hours, for 3 days. In group B, only placebo was given. The patients' background, blood transfusion rates, and early postoperative results in the 2 groups were compared. Factors that influenced blood requirement were analyzed. RESULTS There were 108 hepatectomies in group A and 106 hepatectomies in group B. The patients' backgrounds, operative procedures, and hepatectomy extent did not significantly differ between the 2 groups. Although the differences of the operative morbidity and postoperative stay were not significant, a significantly lower amount of operative blood loss, lower blood transfusion rate, shorter operative time, and lower hospital costs were found in group A patients. No patient in group A received blood transfusion. No hospital mortality occurred in either group. Tumor size and use of TA were independent factors that influenced blood transfusion. CONCLUSIONS Perioperative parenteral use of TA reduced the amount of operative blood loss and the need for blood transfusion in elective liver tumor resection. A real blood transfusion-free hepatectomy may be feasible with the assistance of parenteral TA.