Tranexamic acid in patients with complex stones undergoing percutaneous nephrolithotomy: a randomized, double-blinded, placebo-controlled trial
BJU international. 2021
OBJECTIVES To assess the efficacy and safety of single-dose tranexamic acid on the blood transfusion rate and outcomes of patients with complex kidney stones who have undergone percutaneous nephrolithotomy (PCNL). MATERIAL AND METHODS In a randomized, double-blinded, placebo-controlled trial, 192 patients with complex kidney stone (Guy's Stone Scores III-IV) were prospectively enrolled and randomized (1:1 ratio) to receive either one dose of tranexamic acid (1 g) or a placebo at the time of anesthetic induction for PCNL. The primary outcome measure was the occurrence rate of perioperative blood transfusion. The secondary outcome measures included blood loss, operative time, stone-free rate (SFR), and complications. ClinicalTrials.gov identifier: NCT02966236. RESULTS The overall risk of receiving a blood transfusion was reduced in the tranexamic acid group (2.2% vs 10.4%, relative risk: 0.21, 95% confidence interval (CI): 0.03-0.76; P = 0.033, number-needed-to-treat: 12). Patients randomized to the tranexamic acid group showed higher immediate and three-month SFR compared with those in the placebo group (29% vs 14.7%, odds ratio [95% CI]: 2.37 [1.15-4.87], P = 0.019, and 46.2% vs 28.1%, odds ratio [95% CI]: 2.20 [1.20-4.02], P = 0.011, respectively). Faster hemoglobin recovery was demonstrated by patients in the tranexamic group (mean, 21.3 days, P = 0.001). No statistical differences were found in operative time and complications between groups. CONCLUSIONS Tranexamic acid administration is safe and reduces the need for blood transfusion by five times in patients with complex kidney stones undergoing PCNL. Moreover, tranexamic acid may contributes to better stone clearance rate and faster hemoglobin recovery without increasing complications. A single dose of tranexamic acid at the time of anesthetic induction could be considered standard clinical practice for patients with complex kidney stones undergoing PCNL.
Safety and Efficacy of Tranexamic Acid to Minimise Perioperative Bleeding in Hepatic Surgery: A Systematic Review and Meta-Analysis
World journal of surgery. 2021
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.
Safety and efficacy of tranexamic acid in minimizing perioperative bleeding in extrahepatic abdominal surgery: meta-analysis
BJS open. 2021;5(2)
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.
Tranexamic Acid in Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis
Critical care medicine. 2021
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.
The topical application of tranexamic acid to control bleeding in inguinal hernia surgery candidate patients: A randomized controlled trial
Annals of medicine and surgery (2012). 2021;69:102683
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.
Is There Any Clinical Benefit for Peri-operative Administration of Tranexamic Acid for Patients Undergoing Percutaneous Nephrolithotomy? A Systematic Review and Meta-analysis
Current urology reports. 2021;22(12):65
PURPOSE OF REVIEW The purpose of current systematic review and meta-analysis is to determine the efficacy and safety of the administration of tranexamic acid in patients undergoing PCNL. The study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. This systematic review and meta-analysis includes randomized comparative prospective studies. RECENT FINDINGS The primary endpoints were the hemoglobin drop, the bleeding complications, and the transfusion rate. Secondary endpoints included the operative time, the stone-free rate, the hospital stay, and the overall complications. Two-thousand five-hundred six publications were screened for this study. Six RCTs (1262 patients) were included in the meta-analysis. As for our primary endpoints, the hemoglobin drop was lower in the tranexamic group than in the control group, with mean difference (MD) of - 0.65 (p < 0.0001); the bleeding complications were rarer in the tranexamic group than in the control group, with an odds ratio (OR) of 0.32 (p < 0.00001); and the transfusion rate was lower in the tranexamic group with an OR of 0.34 (p = 0.0007). Concerning the secondary endpoints, the operative time was less in the tranexamic group with an MD of - 10.39 (p < 0.0001), the meta-analysis of the stone-free status data showed no statistical significance between the two groups with an OR of 1.58 (p = 0.09), the hospital stay was significantly less in the tranexamic group with an MD of - 1.38 (p = 0.005), and the overall complications were rarer in the tranexamic group than in the control group with an OR of 0.34 (p = 0.12). The peri-operative use of TA contributes to the reduction of blood loss, bleeding complications, mean operative time, and hospital stay. The use of TA seemed to be safe and well tolerated in patients undergoing PCNL. PROSPERO protocol (Registration number: CRD42019122818).
Effect of tranexamic acid on bleeding outcomes after percutaneous nephrolithotomy: A systematic review and meta-analysis of randomized controlled trials
Journal of endourology. 2021
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.
The efficacy and safety of tranexamic acid in the management of perioperative bleeding after percutaneous nephrolithotomy: A systematic review and meta-analysis of comparative studies
Journal of endourology. 2021
INTRODUCTION We performed a systematic review and meta-analysis of the current literature to assess the efficacy and safety of tranexamic acid (TXA) in the management of postoperative bleeding after percutaneous nephrolithotomy (PCNL). METHODS A systematic literature review was performed in March 2021. Two reviewers independently screened, identified, and evaluated comparative studies assessing the effectiveness of TXA in preventing bleeding following PCNL when compared to placebo or no intervention. The incidence of transfusion, complete stone clearance, and complications were extracted among TXA and control groups to generate the Risk Ratio (RR) and corresponding 95% confidence interval (CI). Blood loss, hemoglobin (Hb) drop, length of hospital stays, and operative (OR) time were analysed using standard mean difference (SMD) with corresponding 95% CI. Effect estimates were pooled using the inverse-variance approach with a random-effect model. RESULTS A total of 11 studies (8 randomized controlled trial, 1 prospective cohort, 2 retrospective cohort studies; total 1842 patients) of low-to-moderate-quality were included in the meta-analysis. Overall pooled effect estimates demonstrated a decreased transfusion rate (RR 0.36; 95% CI 0.25 to 0.51), blood loss (SMD -0.74; 95% CI -1.14 to -0.34) and Hb drop (SMD -0.95; 95% CI -1.51 to -0.39) among patients in the TXA group when compared to those in the control. The number needed to treat was 11 to prevent one transfusion. Patients who received TXA also had improved stone clearance (RR 1.08; 95% CI 1.02 to 1.14), lower minor (RR 0.72; 95% CI 0.58 to 0.89) and major (RR 0.38; 95% CI 0.21 to 0.69) complications, shorter hospital stays (SMD -0.52; 95% CI -1.01 to -0.04) and decreased OR time (SMD -0.89; 95% CI -1.46 to -0.31). CONCLUSIONS TXA can effectively reduce postoperative bleeding following PCNL. Future studies should identify a subset of patients who may benefit from preoperative TXA administration for PCNL.
The Effects of Tranexamic Acid on Bleeding Control During and after Percutaneous Nephrolithotomy (PCNL): A Randomized Clinical Trial
Urology journal. 2021;:6505
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.
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
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.
Patients with gastrointestinal bleeding enrolled in the HALT-IT trial (n= 12009).
Loading dose of tranexamic acid followed by a maintenance dose of tranexamic acid (n= 5994).
Placebo: sodium chloride (n= 6015).
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%).