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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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Tranexamic acid for percutaneous nephrolithotomy
Cleveland, B., Norling, B., Wang, H., Gandhi, V., Price, C. L., Borofsky, M. S., Pais, V., Dahm, P.
The Cochrane database of systematic reviews. 2023;10(10):Cd015122
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Editor's Choice
Abstract
BACKGROUND Percutaneous nephrolithotomy (PCNL) is the gold standard for the treatment of large kidney stones but comes with an increased risk of bleeding compared to other treatments, such as ureteroscopy and shock wave lithotripsy. Tranexamic acid (TXA) is an antifibrinolytic agent that has been used to reduce bleeding complications in other settings. OBJECTIVES To assess the effects of TXA in individuals with kidney stones undergoing PCNL. SEARCH METHODS We performed a comprehensive literature search of the Cochrane Library, PubMed (including MEDLINE), Embase, Scopus, Global Index Medicus, trials registries, other sources of the grey literature, and conference proceedings. We applied no restrictions on the language of publication nor publication status. The latest search date was 11 May 2023. SELECTION CRITERIA We included randomized controlled trials (RCTs) that compared treatment with PCNL with administration of TXA to placebo (or no TXA) for patients ≥ 18 years old. DATA COLLECTION AND ANALYSIS Two review authors independently classified studies and abstracted data. Primary outcomes were: blood transfusion, stone-free rate (SFR), and thromboembolic events (TEEs). Secondary outcomes were: adverse events (AEs), secondary interventions, major surgical complications, minor surgical complications, unplanned hospitalizations or readmissions, and hospital length of stay (LOS). We performed statistical analyzes using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach using a minimally contextualized approach with predefined thresholds for minimally clinically important differences (MCIDs). MAIN RESULTS We analyzed 10 RCTs assessing the effect of systemic TXA in PCNL versus placebo (or no TXA) with 1883 randomized participants. Eight studies were published as full text. One was published in abstract proceedings, but it was separated into two separate studies for the purpose of our analyzes. Average stone surface area ranged 3.45 to 6.62 cm(2). We also found a single RCT published in full text assessing the effects of topical TXA in PCNL versus placebo (or no TXA) with 400 randomized participants, the results of which are further described in the review. Here we focus only on the results of TXA used systemically. Blood transfusion - Based on a representative baseline risk of 5.7% for blood transfusions taken from a large presentative observational studies, systemic TXA may reduce blood transfusions (risk ratio (RR) 0.45, 95% confidence interval (CI) 0.27 to 0.76; I(2) = 28%; 9 studies, 1353 participants; low CoE). We assumed an MCID of ≥ 2%. Based on 57 participants per 1000 with placebo (or no TXA) being transfused, this corresponds to 31 fewer (from 42 fewer to 14 fewer) participants being transfused per 1000. Stone-free rate - Based on a representative baseline risk of 75.7% for SFR, systemic TXA may increase SFRs (RR 1.11, 95% CI 0.98 to 1.27; I(2) = 62%; 4 studies, 603 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 757 participants per 1000 being stone free with placebo (or no TXA), this corresponds to 83 more (from 15 fewer to 204 more) stone-free participants per 1000. Thromboembolic events - There is probably no difference in TEEs (risk difference (RD) 0.00, 95% CI -0.01 to 0.01; I(2) = 0%; 6 studies, 841 participants; moderate CoE). We assumed an MCID of ≥ 2%. Since there were no thromboembolic events in intervention and/or control groups in 5 out of6 studies, we opted to assess a risk difference with systemic TXA for this outcome. Adverse events - Systemic TXA may increase AEs (RR 5.22, 95% CI 0.52 to 52.72; I(2) = 75%; 4 studies, 602 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 23 participants per 1000 with placebo (or no TXA) having an adverse event, this corresponds to 98 more (from 11 fewer to 1000 more) participants with adverse events per 1000. Secondary interventions - Systemic TXA may have little to no effect on secondary interventions (RR 1.15, 95% CI 0.84 to 1.57; I(2) = 0%; 2 studies, 319 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 278 participants per 1000 with placebo (or no TXA) having a secondary intervention, this corresponds to 42 more (from 44 fewer to 158 more) participants with secondary interventions per 1000. Major surgical complications - Based on a representative baseline risk for major surgical complications of 4.1%, systemic TXA may reduce major surgical complications (RR 0.36, 95% CI 0.21 to 0.62; I(2) = 0%; 5 studies, 733 participants; moderate CoE). We assumed an MCID of ≥ 2%. Based on 41 participants per 1000 with placebo (or no TXA) having a major surgical complication, this corresponds to 26 fewer (from 32 fewer to 16 fewer) participants with major surgical complications per 1000. Minor surgical complications - Systemic TXA may reduce minor surgical complications (RR 0.71, 95% CI 0.45 to 1.10; I(2) = 76%; 5 studies, 733 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 396 participants per 1000 with placebo (or no TXA) having a minor surgical complication, this corresponds to 115 fewer (from 218 fewer to 40 more) participants with minor surgical complications per 1000. Unplanned hospitalizations or readmissions - We are very uncertain how unplanned hospitalizations or readmissions are affected (RR 1.55, 95% CI 0.45 to 5.31; I(2) = not applicable; 1 study, 189 participants; very low CoE). We assumed an MCID of ≥ 2%. Hospital length of stay - Systemic TXA may reduce hospital LOS (mean difference 0.52 days lower, 95% CI 0.93 lower to 0.11 lower; I(2) = 98%; 7 studies, 1151 participants; low CoE). We assumed an MCID of ≥ 0.5 days. AUTHORS' CONCLUSIONS Based on 10 RCTs with substantial methodological limitations that lowered all CoE of effect, we found that systemic TXA in PCNL may reduce blood transfusions, major and minor surgical complications, and hospital LOS, as well as improve SFRs; however, it may increase AEs. We are uncertain about the effects of systemic TXA on other outcomes. Findings of this review should assist urologists and their patients in making informed decisions about the use of TXA in the setting of PCNL.
PICO Summary
Population
Patients with kidney stones undergoing percutaneous nephrolithotomy (PCNL), (10 randomised controlled trials (RCTs), n= 1,883).
Intervention
Tranexamic acid.
Comparison
Placebo or no tranexamic acid.
Outcome
The primary outcomes were: blood transfusion, stone-free rate, and thromboembolic events. Based on 10 RCTs with substantial methodological limitations that lowered all certainty of evidence of effect, the authors found that systemic tranexamic acid in PCNL may reduce blood transfusions, major and minor surgical complications, and hospital length of stay, as well as improve stone-free rates; however, it may increase adverse events. The authors were uncertain about the effects of systemic TXA on other outcomes.
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Tranexamic acid for percutaneous nephrolithotomy: an abridged Cochrane Review
Cleveland, B., Norling, B., Wang, H., Gandhi, V., Price, C. L., Borofsky, M., Pais, V., Dahm, P.
BJU international. 2023
Abstract
PURPOSE To assess the effects of tranexamic acid (TXA) in individuals with kidney stones undergoing percutaneous nephrolithotomy (PCNL). MATERIALS AND METHODS We performed a literature search of Cochrane Library, PubMed (including MEDLINE), Embase, Scopus, Global Index Medicus, trials registries, grey literature, and conference proceedings. We included randomized controlled trials (RCT) that compared treatment with PCNL with administration of TXA to placebo (or no TXA) for patients ≥18 years old. Two review authors independently classified studies and abstracted data. Primary outcomes were blood transfusion, stone free rate (SFR), thromboembolic events (TEE). We rated the certainty of evidence (CoE) according to the GRADE approach using a minimally contextualized approach with predefined thresholds for minimally clinically important differences (MCID). RESULTS We included 10 RCTs assessing the effect of systemic TXA in PCNL versus placebo (or no TXA). Eight studies were published as full-text. Based on an adjusted baseline risk of blood transfusion of 5.7%, systemic TXA may reduce blood transfusions (RR 0.45, 95% CI 0.27 to 0.76). Based on an adjusted baseline SFR of 75.7%, systemic TXA may increase SFR (RR 1.11, 95% CI 0.98 to 1.27). There is probably no difference in TEEs (risk difference (RD) 0.00, 95% CI -0.01 to 0.01). Systemic TXA may increase AE (RR 5.22, 95% CI 0.52 to 52.72). Systemic TXA may have little to no effect on secondary interventions (RR1.15, 95% CI 0.84 to 1.57). The CoE for most outcomes was assessed as low or very low. CONCLUSIONS Based on a body of evidence of 10 RCTs, we found that systemic TXA in PCNL may reduce blood transfusions, major surgical complications, and hospital LOS, as well as improve SFR; however, it may increase AE. These findings should inform urologists and their patients in making informed decisions about the use of TXA in the setting of PCNL.
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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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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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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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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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Role of Tranexamic Acid (TXA) in Preventing Bleeding Following Sleeve Gastrectomy: a Systematic Review and Meta-analysis
Mocanu, V., Wilson, H., Verhoeff, K., Kung, J., Walsh, C., Koloszvari, N., Neville, A., Karmali, S.
Obesity Surgery. 2023
Abstract
BACKGROUND Tranexamic acid (TXA) has drawn growing interest over the last decade for its benefit in optimizing post-operative bleeding, yet its role in bariatric surgery is poorly understood. METHODS The medical librarian developed and executed comprehensive searches on September 28, 2022. The population of interest included adults who underwent elective bariatric surgery. The intervention was tranexamic acid administration while the comparison was placebo or standard peri-operative therapy. The primary outcome of interest was post-operative bleeding which was defined a priori. RESULTS A total of four studies were identified comprising of 475 patients. Of those, 207 (50%) received TXA at induction and all underwent laparoscopic sleeve gastrectomy (LSG). The majority of patients were female (n = 343, 80.7%) with ages ranging from 17 to 70 years of age and mean BMIs ranging from 37 to 56 kg/m(2). Post-operative bleeding after LSG ranged from 0 to 28% depending on bleed definition and TXA administration with no differences in venous thromboembolic events or mortality between groups. Meta-analysis of post-operative bleeding demonstrated a statistically significant benefit with TXA administration (OR 0.40; 95% CI 0.23-0.70; p = 0.001) for patients undergoing elective LSG. CONCLUSIONS Intravenous tranexamic acid at the time of laparoscopic sleeve gastrectomy is associated with a significant reduction of post-operative bleeding with no observed differences in thromboembolic events or mortality. Further high-quality studies are needed to better delineate the ideal bariatric population to receives TXA in addition to the optimal timing, dose, and duration of TXA therapy.
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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 Use for Hemorrhagic Events Prevention in Percutaneous Nephrolithotomy: Systematic Review and Meta-analysis
Baccaglini W, Rodrigues AFS, Glina FP, Dall'Aqua V, Glina S, Lopes Neto AC
Journal of endourology. 2022
Abstract
PURPOSE Analyze the impact of Tranexamic acid (TA) use after percutaneous nephrolithotomy (PNL) on blood loss and transfusion rate (TR), and secondary outcomes, complications rate and stone free rates (SFR), Operative time (OT) and length of hospital stay (LOS). MATERIALS AND METHODS Search made in the Medline (PubMed), Embase, and Central Cochrane for studies published up to August 2021. The study protocol was registered at PROSPERO (CRD42020182197). Eligibility criteria were defined based on PICOS. Articles included were those who assessed the effect of intravenous TA in patients submitted to PNL. Only randomized placebo-controlled trial which included patients with and without TA perioperatively. Results: A total of 1,151 patients were included in 7 studies. Six studies presented a lower blood TR for the TA group (P<0.00001). Four studies presented similar results in relation a lower stone free rate (SFR) (P=0.004), and similar results regarding overall complication rate for the control group (P=0.03). Regarding the 'major complication rate' (Clavien-Dindo ≥3), no difference was found (P=0.07). Four studies showed a higher mean OT for the control group (159 x 151 minutes, respectively, P=0.003). Six studies found a lower mean LOS in the TA group (4.0 x 3.5 days, respectively, P=0.03). CONCLUSIONS The benefit of TXA use in the setting of PCNL perioperative is clear. Our study showed favorable results to TXA use in relation to TR, SFR, complication rate, OT and LOS, but these results did not translate into a lower major complication rate. Further studies evaluating the complexity of the calculi and events unrelated to PCNL may help us to select which patients will benefit from the use of TXA.