-
1.
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
-
-
-
Full text
-
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.
-
2.
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.
-
3.
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.
-
4.
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
-
-
Free full text
-
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.
-
5.
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.
-
6.
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.
-
7.
Tranexamic Acid in Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis
Dionne JC, Oczkowski SJW, Hunt BJ, Antonelli M, Wijnberge M, Raasveld SJ, Vlaar APJ
Critical care medicine. 2021
Abstract
OBJECTIVES Tranexamic acid is proposed as a treatment for gastrointestinal bleeding. The Haemorrhage Alleviation with Tranexamic Acid-Intestinal System trial evaluated extended-use (24 hr) high-dose tranexamic acid, prompting a reappraisal for tranexamic acid in gastrointestinal bleeding. DATA SOURCES We conducted a systematic review and meta-analysis of randomized controlled trials comparing tranexamic acid with usual care or placebo in adults with gastrointestinal bleeding. We searched MEDLINE, EMBASE, and CENTRAL (inception to September 2019). DATA SELECTION Two reviewers independently screened citations, extracted data, and assessed the risk of bias using the Cochrane risk of bias tool in duplicate. The main outcomes were mortality, bleeding, and adverse events. DATA EXTRACTION Studies were analyzed as high-dose IV tranexamic acid versus all other dosing strategies for tranexamic acid using fixed-effects models. We assessed certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. DATA SYNTHESIS Five randomized controlled trials evaluated extended-use high-dose IV tranexamic acid, seven evaluating low-dose IV or enteral tranexamic acid. Extended-use high-dose IV tranexamic acid did not reduce mortality (relative risk, 0.98%; 95% CI, 0.88-1.09; I2 = 63%; high certainty) or bleeding (relative risk, 0.92; 95% CI, 0.82-1.04; p = 0.17 and absolute risk differences, -0.7%; 95% CI, -1.5 to 0.3; high certainty) but resulted in a small increase in deep venous thrombosis (relative risk, 2.01; 95% CI, 1.08-3.72; I2 = 0%), pulmonary embolism (relative risk, 1.78; 95% CI, 1.06-3.0; I2 = 0%), and seizure (relative risk, 1.73; 95% CI, 1.03-2.93) with high certainty. Low-dose IV/enteral tranexamic acid did not reduce mortality (relative risk, 0.62; 95% CI, 0.36-1.09; I2 = 0%) but did reduce risk of rebleeding (relative risk, 0.5; 95% CI, 0.33-0.75; I2 = 9%) and need for surgery (relative risk, 0.58; 95% CI, 0.38-0.88; I2 = 11%), with moderate certainty. CONCLUSIONS Extended-use high-dose IV tranexamic acid does not improve mortality or bleeding outcomes and increases adverse events. Low-dose/enteral tranexamic acid may be effective in reducing hemorrhage; more evidence is required to demonstrate its safety.
-
8.
Safety and Efficacy of Tranexamic Acid to Minimise Perioperative Bleeding in Hepatic Surgery: A Systematic Review and Meta-Analysis
Koh A, Adiamah A, Gomez D, Sanyal S
World journal of surgery. 2021
Abstract
INTRODUCTION Perioperative bleeding poses a major risk during liver surgery, which can result in increased transfusion requirements, morbidity, and mortality. Tranexamic acid (TXA) effectively reduces perioperative bleeding and transfusion requirements in trauma patients. However, there remains a lack of evidence of its use in liver surgery. This meta-analysis of randomised controlled trials evaluated the efficacy and safety of TXA in liver resection and transplantation. METHOD A comprehensive search of Medline, Embase, CENTRAL and Clinicaltrials.gov databases was undertaken to identify studies from January 1947 to September 2021. The outcomes of the need for blood transfusion, thromboembolic events and mortality were extracted from the included studies. Quantitative pooling of data was based on the random effects model. RESULTS Six studies reporting on 429 patients were included. TXA reduced the need for perioperative blood transfusion in liver resection and transplantation (OR 0.09; 95% CI 0.01 to 0.72). More importantly, TXA did not increase the incidence of thromboembolic events (OR 2.22; 95% CI 0.47 to 10.43) and mortality (OR 0.60; 95% CI 0.13 to 2.76). CONCLUSION TXA safely reduces the need for blood transfusion in patients undergoing liver resection and transplantation.
-
9.
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.
-
10.
Effect of tranexamic acid on bleeding outcomes after percutaneous nephrolithotomy: A systematic review and meta-analysis of randomized controlled trials
MacDonald MM, Ilie G, Power LS, Whalen S, Parker R, Skinner TA, Lantz Powers AG
Journal of endourology. 2021
Abstract
PURPOSE We performed a systematic review and meta-analysis of the literature to evaluate the efficacy of the routine use of tranexamic acid during percutaneous nephrolithotomy. METHODS This systematic review was conducted following best practices from Cochrane and the Institute of Medicine [Cochrane Handbook and IOM citations]. We followed the updated reporting guidelines from PRISMA 2020. RESULTS In total 275 titles and abstracts were reviewed, of which 20 were screened to be eligible for full text review. Of these 20 articles, 11 were selected for inclusion after full article evaluations. Seven of these 11 studies were seen as having a low risk of bias with a Jadad score of ≥3. These studies were included for data extraction. Once data was extracted, 964 patients were included. The primary outcome, blood transfusion rate, showed significant reduction with a ratio for transfusion rate of 0.34 [ 95% CI (0.19 to 0.61), z= 3.61, p=0.0003]. Mean Hemoglobin (Hgb) drop, and operative time were both shown to be reduced with the use of TXA. The mean difference for Hgb drop was -0.86 [ 95% CI (-1.26 to -0.46), z= 4.23, p< 0.0001]. Reduction in operative time showed a mean difference of -8.45 min [ 95% CI (-15.04 to -1.86), z= 2.51, p= 0.01]. Stone clearance was not shown to differ significantly between experimental and control groups, with a risk ratio of 1.28 [ 95% CI (0.89 to 1.84), z= 1.31, p= 0.19]. CONCLUSIONS This meta-analysis revealed that the routine use of TXA at time of PCNL reduces the rates of blood transfusion, mean Hgb drop, and operative time. With the low cost of TXA and strong safety profile, stronger consideration should be given to the routine use of TXA during PCNL by endoscopic surgeons.