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Prophylactic tranexamic acid to reduce blood loss and related morbidities during hysterectomy: a systematic review and meta-analysis of randomized controlled trials.

ABSTRACT: To perform a systematic review and meta-analysis of all randomized controlled trials (RCTs) that evaluated the efficacy and safety of prophylactic tranexamic acid (TXA) versus a control (placebo or no treatment) during hysterectomy for benign conditions. Six databases were screened from inception to January 23, 2022. Eligible studies were assessed for risk of bias. Outcomes were summarized as weighted mean differences and risk ratios with 95% confidence intervals in a random-effects model. Five studies, comprising six arms and 911 patients were included in the study. Two and three studies had an overall unclear and low risk of bias, respectively. Estimated intraoperative blood loss, requirement for postoperative blood transfusion, and requirement for intraoperative topical hemostatic agents were significantly reduced in a prophylactic TXA group when compared with a control group. Moreover, postoperative hemoglobin level was significantly higher in the prophylactic TXA group than in the control group. Conversely, the frequency of self-limiting nausea and vomiting was significantly higher in the prophylactic TXA group than in the control group. There were no significant differences between the groups in terms of surgery duration, hospital stay, and diarrhea rate. All the RCTs reported no incidence of major adverse events in either group, such as mortality, thromboembolic events, visual disturbances, or seizures. There was no publication bias for any outcome, and leave-one-out sensitivity analyses demonstrated stability of the findings. Among patients who underwent hysterectomy for benign conditions, prophylactic TXA appeared largely safe and correlated with substantial reductions in estimated intraoperative blood loss and related morbidities.

SUBMITTER: Abu-Zaid A

PROVIDER: S-EPMC9483668 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Prophylactic tranexamic acid to reduce blood loss and related morbidities during hysterectomy: a systematic review and meta-analysis of randomized controlled trials.

Abu-Zaid Ahmed A Baradwan Saeed S Badghish Ehab E AlSghan Rayan R Ghazi Ahmed A Albouq Bayan B Khadawardi Khalid K AlNaim Nora F NF AlNaim Latifa F LF Fodaneel Meshael M AbuAlsaud Fatimah Shakir FS Jamjoom Mohammed Ziad MZ Almubarki Abdullah Ama AA Alsehaimi Saud Owaimer SO Alabdrabalamir Safa S Alomar Osama O Al-Badawi Ismail A IA Salem Hany H

Obstetrics & gynecology science 20220728 5

To perform a systematic review and meta-analysis of all randomized controlled trials (RCTs) that evaluated the efficacy and safety of prophylactic tranexamic acid (TXA) versus a control (placebo or no treatment) during hysterectomy for benign conditions. Six databases were screened from inception to January 23, 2022. Eligible studies were assessed for risk of bias. Outcomes were summarized as weighted mean differences and risk ratios with 95% confidence intervals in a random-effects model. Five ...[more]

PMID: 35896179

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Project description:BackgroundTotal knee arthroplasty (TKA) is associated with a significant blood loss. Several methods have been reported to reduce postoperative blood loss and avoid homologous blood transfusions. In this study, we investigated the efficacy of temporary clamping of the drain either or not in combination with tranexamic acid administration for controlling blood loss after TKA.MethodsThe prospective, randomized, and double-blinded study was conducted in our institute. Total of 240 patients, who diagnosed primary osteoarthritis and scheduled to undergo a primary TKA,,were randomized into one of the four groups: Group A or control group, the drain was not clamped and the patient received a placebo; Group B, the drain was not clamped and the patient received tranexamic acid; Group C, the drain was clamped and the patient received a placebo; and Group D, the drain was clamped and the patient received tranexamic acid. The volume of drained blood at 48 hours postoperatively, the decreasing of hemoglobin (Hb) level at 12 hours postoperatively and the number of patients requiring blood transfusion were recorded and compared.ResultsThe mean postoperative volumes of drained blood and the amount of blood transfusion in the three study groups (group B, C and D) were significantly lower than those in the control group (p < 0.05), which group D had the lowest values. Furthermore, group B and D could maintain the Hb level better than group A and C (p < 0.001). In terms of blood transfusions rate, although the patients in group D required transfusion less than group A and C (p < 0.05), there was no significant difference between group D and B. The relative risks for transfusion requirement were 4.4 for group A, 1.4 for group B and 3.0 for group C when compared to group D.ConclusionsThe clamping of drain combined with tranexamic acid administration could reduce postoperative blood loss and blood transfusion after TKA, significantly greater than using tranexamic acid or drain clamping alone.Trial registrationClinicalTrials.gov NCT01449552.

Project description:IntroductionTranexamic acid reduces blood loss and allogeneic transfusion requirements in various surgical procedures. The role of tranexamic acid during cytoreductive procedures in advanced ovarian cancer is not clear.Material and methodsThis was a single center randomized, controlled, three-armed clinical trial. A total of 150 ovarian cancer patients undergoing cytoreductive surgery were recruited and assigned to three groups (n = 50/group): the control group (normal saline), low-dose group (10 mg/kg bolus + 1 mg/kg continuous infusion of tranexamic acid), and high-dose group (20 mg/kg bolus + 5 mg/kg continuous infusion of tranexamic acid). The primary endpoint was intraoperative blood loss volume and total blood loss volume, and secondary endpoints included intraoperative blood transfusion volumes, vasoactive agent consumption, admission into the intensive care unit, and incidence of postoperative complications within postoperative 30 days. The study was registered at ClinicalTrials.gov ID: NCT04360629.ResultsThe patients in the high-dose group had less intraoperative (median [IQR]: 625.3 mL [343.5-1210.5]) and total blood loss volume (748.9 mL [292.2-1650.2]) than those in the control group (1015.5 mL [679.4-1015.5], p = 0.012; and 1700.7 mL [458.7-2419.8], p = 0.004, respectively). In contrast, the intraoperative (992.5 mL [539.0-1404.0], p = 0.874) and total blood loss volume (1025.0 mL [381.8-1819.9], p = 0.113) was not significantly reduced in the low-dose group when compared with the control group. Correspondingly, the relative risk of blood transfusion (RR [95% CI], 0.405 [0.180-0.909], p = 0.028) was reduced in the high-dose group and required less intraoperative noradrenaline (881.0 ± 438.3 mg) to maintain stable hemodynamics than the control group (1548.0 ± 349.8 mg, p = 0.001). Furthermore, compared with the control group, the two tranexamic acid groups had decreased intensive care unit admission rates (p = 0.016) without increasing the incidence of postoperative seizure, acute kidney injury, and thromboembolism.ConclusionsHigh-dose tranexamic acid is more effective in reducing blood loss and blood transfusion without increasing the risk of postoperative complications. The high-dose regime tended to have a better risk-benefit profile.

Project description:BackgroundTranexamic acid (TXA) has been widely used in orthopedic surgery, but its efficacy in adolescent scoliosis (AS) surgery remains unclear in the literature. The purpose of this systematic review and meta-analysis is to evaluate the safety and efficacy of TXA compared to placebo treatment during or after AS surgery, by gathering data from randomized both controlled trials (RCTs) and non-RCTs.MethodsEnglish and Chinese electronic databases including PubMed, Web of Science, Embase, Cochrane, CNKI, and Wan Fang database were searched to identify the relevant literature up until August 2022. The primary outcomes were intraoperative blood loss and total blood loss. The secondary outcomes included the need for transfusion, postoperative hemoglobin (Hb) level, and change in Hb level. Stata 17 was used for data analysis and the risk of bias was assessed. We followed the PRISMA checklist to ensure the quality of this article.ResultsTwelve studies (795 participants) were included in the meta-analysis for intraoperative blood loss during surgery. The results suggest that TXA can reduce the intraoperative blood loss of the patients (MD = -306.40ml, 95%CI = -404.04ml to -208.77ml, p < 0.001). Six studies (2027 patients) were included in the meta-analysis for total blood loss. The pooled result shows that the total blood loss of the TXA group was significantly lower than that of the control group (MD = -779.24ml, 95% CI = -1157.10ml to -410.39ml, p < 0.001). Five studies (419 patients) were included in the meta-analysis for postoperative Hb level and shows a non-significant outcome (MD = 5.09 g/l, 95%CI = 2.92 g/l to 7.25 g/l, p = 0.611). Three studies (268 patients) were included in the meta-analysis for the postoperative Hb level. There is a non-significant decrease in the TXA group (MD = -0.23 g/l, 95%CI = -0.48 g/l to 0.01 g/l, p = 0.319). Eight studies (670 patients) reported data on the need for transfusion after surgery. The overall relative risks (RR) showed a significant difference between the TXA and control group, with a lower risk of transfusion in the TXA group (RR = 0.547, 95%CI = 0.308 to 0.972, p = 0.04).ConclusionsThe meta-analysis of the data reveals that TXA usage is associated with a significant reduction in intraoperative and total blood loss, a lower risk of transfusion, and a non-significant change in postoperative Hb levels in AS surgery However, it should be noted that the surgical operation situations varied across different studies. Therefore, further research is required to investigate the effects of TXA on specific subgroups of gender, operation time, and blood transfusion indicators. Overall, our study provides valuable evidence for the clinical management of AS surgery and may inform the development of practice guidelines and protocols for the use of TXA in this setting.

Project description:BackgroundPost-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage.MethodsIn this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283.FindingsBetween March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65-1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52-0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88-1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus placebo group.InterpretationTranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset.FundingLondon School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation.

Dataset Information

Prophylactic tranexamic acid to reduce blood loss and related morbidities during hysterectomy: a systematic review and meta-analysis of randomized controlled trials.

Publications

Prophylactic tranexamic acid to reduce blood loss and related morbidities during hysterectomy: a systematic review and meta-analysis of randomized controlled trials.

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