Dataset Information

Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol).

ABSTRACT:

Introduction

Bleeding during cardiac surgery is associated with increased morbidity and mortality. Tranexamic acid is an antifibrinolytic with proven efficacy in major surgeries. Current clinical practice guidelines recommend intraoperative use in cardiac procedures. However, several complications have been reported with tranexamic acid including seizures. This review intends to summarise the evidence examining the efficacy and safety of tranexamic acid in patients undergoing cardiac surgery.

Methods/design

We will search MEDLINE, Embase, PubMED, ACPJC, CINAHL and the Cochrane trial registry for eligible randomised controlled trials, the search dates for all databases will be from inception until 1 January 2019, investigating the perioperative use of topical and/or intravenous tranexamic acid as a stand-alone antifibrinolytic agent compared with placebo in patients undergoing open cardiac surgery. We categorised outcomes as patient critical or patient important. Selected patient-critical outcomes are: mortality (intensive care unit, hospital and 30-day endpoints), reoperation within 24?hours, postoperative bleeding requiring transfusion of packed red blood cells, myocardial infarction, stroke, pulmonary embolism, bowel infarction, upper or lower limb deep vein thrombosis and seizures. Those outcomes, we perceived as clinical experts to be most patient valued and patients were not involved in outcomes selection process. We will not apply publication date, language, journal or methodological quality restrictions. Two reviewers will independently screen and identify eligible studies using predefined eligibility criteria and then review full reports of all potentially relevant citations. A third reviewer will resolve disagreements if consensus cannot be achieved. We will present the results as relative risk with 95% CIs for dichotomous outcomes and as mean difference or standardised mean difference for continuous outcomes with 95% CIs. We will assess the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation approach.

Ethics and dissemination

Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication TRIAL REGISTRATION NUMBER: CRD42018105904.

SUBMITTER: Alaifan T

PROVIDER: S-EPMC6756438 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol).

Alaifan Thamer T Alenazy Ahmed A Xiang Wang Dominic D Fernando Shannon M SM Spence Jessica J Belley-Cote Emilie E Fox-Robichaud Alison A Ainswoth Craig C Karachi Tim T Kyeremanteng Kwadwo K Zarychanski Ryan R Whitlock Richard R Rochwerg Bram B

BMJ open 20190917 9

<h4>Introduction</h4>Bleeding during cardiac surgery is associated with increased morbidity and mortality. Tranexamic acid is an antifibrinolytic with proven efficacy in major surgeries. Current clinical practice guidelines recommend intraoperative use in cardiac procedures. However, several complications have been reported with tranexamic acid including seizures. This review intends to summarise the evidence examining the efficacy and safety of tranexamic acid in patients undergoing cardiac sur ...[more]

PMID: 31530593

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Project description:BackgroundTranexamic acid (TXA) is well-established as a versatile oral, intramuscular, and intravenous (IV) antifibrinolytic agent. However, the efficacy of IV TXA in reducing perioperative blood transfusion in spinal surgery is poorly documented.MethodologyWe conducted a meta-analysis of randomized controlled trials (RCTs) and quasi-randomized (qi-RCTs) trials that included patients for various spinal surgeries, such as adolescent scoliosis surgery administered with perioperative IV TXA according to Cochrane Collaboration guidelines using electronic PubMed, Cochrane Central Register of Controlled Trials, and Embase databases. Additional journal articles and conference proceedings were manually located by two independent researchers.ResultsTotally, nine studies were included, with a total sample size of 581 patients. Mean blood loss was decreased in patients treated with perioperative IV TXA by 128.28 ml intraoperatively (ranging from 33.84 to 222.73 ml), 98.49 ml postoperatively (ranging from 83.22 to 113.77 ml), and 389.21 ml combined (ranging from 177.83 to 600.60 ml). The mean volume of transfused packed cells were reduced by 134.55 ml (ranging 51.64 to 217.46) (95% CI; P?=?0.0001). Overall, the number of patients treated with TXA who required blood transfusions was lower by 35% than that of patients treated with the comparator and who required blood transfusions (RR 0.65; 95% CI; 0.53 to 0.85; P<0.0001, I(2)?=?0%). A dose-independent beneficial effect of TXA was observed, and confirmed in subgroup and sensitivity analyses. A total of seven studies reported DVT data. The study containing only a single DVT case was not combined.ConclusionsThe blood loss was reduced in spinal surgery patients with perioperative IV TXA treatment. Also the percentage of spinal surgery patients who required blood transfusion was significantly decreased. Further evaluation is required to confirm our findings before TXA can be safely used in patients undergoing spine surgery.

Project description:BackgroundTranexamic acid (TXA) is widely used across surgical specialties to reduce perioperative bleeding. It has been shown to be effective in spinal surgery and lower limb arthroplasty. Among all languages, there are no systematic reviews or meta-analyses investigating its clinical effectiveness for all types of shoulder surgery.PurposeTo investigate the clinical effectiveness of TXA in all types of shoulder surgery, including open and arthroscopic procedures. To investigate the effect of TXA on bleeding and non-bleeding-related outcomes.Study designSystematic review and meta-analysis.MethodsA protocol for the study was designed and registered with PROSPERO (CRD42020185482). The literature search included the MEDLINE, Embase, PsycINFO, and Cochrane Library databases. All randomized controlled trials evaluating the use of TXA against placebo, in all types of shoulder surgery, were included. Assessments were undertaken for risk of bias and certainty of evidence. The primary outcome was total blood loss. Secondary outcomes included those not directly related to bleeding. Data from comparable outcomes were pooled and analyzed quantitatively or descriptively, as appropriate.ResultsEight randomized controlled trials were included in the systematic review, and data from 7 of these studies were pooled in the meta-analysis. Pooled analysis demonstrated a significant reduction in 2 of 3 outcomes measuring perioperative bleeding with TXA compared with controls: estimated total blood loss (mean difference, -209.66 mL; 95% CI, -389.11 to -30.21; P = .02) and postoperative blood loss as measured by drain output (mean difference, -84.8 mL; 95% CI, -140.04 to -29.56; P = .003). Hemoglobin reduction was reduced but not statistically significant (mean difference, -0.33 g/dL; 95% CI -0.69 to 0.03; P = .07). This result became significant with sensitivity analysis excluding arthroscopic procedures.ConclusionThis systematic review and meta-analysis indicated that TXA was effective in reducing blood loss in shoulder surgery. Larger randomized controlled trials with low risk of bias for specific surgical shoulder procedures are required.Clinical relevanceTXA can be used across shoulder surgery to reduced perioperative blood loss. The use of TXA may have other beneficial features, including reduced postoperative pain and reduced operative time.

Project description:ObjectiveThe present meta-analysis was conducted to compare the efficacy and safety of intravenous application of tranexamic acid (TXA) with placebo in patients with hip fracture undergoing hip surgeries.MethodsPubMed, EMBASE and Cochrane Library were searched from inception until March 2018. A combined searching strategy of subject words and random words was adopted. Only randomized clinical trials were included. The comparisons regarding transfusion rate, total blood loss, intraoperative blood loss, postoperative blood loss, postoperative haemoglobin and postoperative thromboembolic complications were conducted. The meta-analysis was performed using Review Manager 5.3, and the bias evaluation was based on the Cochrane Handbook 5.1.0.ResultsTen randomized controlled trials published from 2007 to 2018 were included in the meta-analysis. The results showed that there were significant differences in the two groups concerning transfusion rate of allogeneic blood [risk ratio (RR) = 0.66, 95% confidence interval (CI): 0.56 to 0.78, P = 0.003], total blood loss [mean difference (MD) = -273.00, 95% CI: -353.15 to -192.84, P < 0.00001], intraoperative blood loss (MD = -76.63, 95% CI: -139.55 to -13.71, P = 0.02), postoperative blood loss (MD = -125.29, 95% CI: -221.96 to -28.62, P = 0.01) and postoperative haemoglobin (MD = 0.80, 95% CI: 0.38 to 1.22, P = 0.0002). Nonsignificant differences were found in the incidence of thromboembolic events (RR = 1.38, 95% CI: 0.74 to 2.55, P = 0.31).ConclusionsThis meta-analysis of the available evidence implies that the intravenous route of TXA shows an ability to reduce transfusion requirements and total blood loss, not increasing the incidence of thromboembolic events in patients undergoing hip surgeries.The translational potential of this articleThe result of this meta-analysis shows that the utilization of intravenous TXA in patients with hip fracture undergoing hip surgeries possesses great potential in reducing blood loss and allogeneic blood transfusion safely.

Project description:ObjectiveTo assess the effect of tranexamic acid on blood transfusion, thromboembolic events, and mortality in surgical patients.DesignSystematic review and meta-analysis.Data sourcesCochrane central register of controlled trials, Medline, and Embase, from inception to September 2011, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of relevant articles.Study selectionRandomised controlled trials comparing tranexamic acid with no tranexamic acid or placebo in surgical patients. Outcome measures of interest were the number of patients receiving a blood transfusion; the number of patients with a thromboembolic event (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism); and the number of deaths. Trials were included irrespective of language or publication status.Results129 trials, totalling 10,488 patients, carried out between 1972 and 2011 were included. Tranexamic acid reduced the probability of receiving a blood transfusion by a third (risk ratio 0.62, 95% confidence interval 0.58 to 0.65; P<0.001). This effect remained when the analysis was restricted to trials using adequate allocation concealment (0.68, 0.62 to 0.74; P<0.001). The effect of tranexamic acid on myocardial infarction (0.68, 0.43 to 1.09; P = 0.11), stroke (1.14, 0.65 to 2.00; P = 0.65), deep vein thrombosis (0.86, 0.53 to 1.39; P = 0.54), and pulmonary embolism (0.61, 0.25 to 1.47; P=0.27) was uncertain. Fewer deaths occurred in the tranexamic acid group (0.61, 0.38 to 0.98; P = 0.04), although when the analysis was restricted to trials using adequate concealment there was considerable uncertainty (0.67, 0.33 to 1.34; P = 0.25). Cumulative meta-analysis showed that reliable evidence that tranexamic acid reduces the need for transfusion has been available for over 10 years.ConclusionsStrong evidence that tranexamic acid reduces blood transfusion in surgery has been available for many years. Further trials on the effect of tranexamic acid on blood transfusion are unlikely to add useful new information. However, the effect of tranexamic acid on thromboembolic events and mortality remains uncertain. Surgical patients should be made aware of this evidence so that they can make an informed choice.

Project description:BackgroundThe efficacy of tranexamic acid (TXA) to reduce perioperative blood loss and allogeneic blood transfusion in cardiac surgeries has been proved in previous studies, but its adverse effects especially seizure has always been a problem of concern. This meta-analysis aims to provide information on the optimal dosage and delivery method which is effective with the least adverse outcomes.MethodsWe searched Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE for all relevant articles published before 2018/12/31. Inclusion criteria were adult patients undergoing elective heart surgeries, and only randomized control trials comparing TXA with placebo were considered. Two authors independently assessed trial quality and extracted relevant data.ResultsWe included 49 studies with 10,591 patients into analysis. TXA significantly reduced transfusion rate (RR 0.71, 95% CI 0.65 to 0.78, P<0.00001). The overall transfusion rate was 35%(1573/4477) for patients using TXA and 49%(2190/4408) for patients in the control group. Peri-operative blood loss (MD -?246.98?ml, 95% CI -?287.89 to -?206.06?ml, P<0.00001) and re-operation rate (RR 0.62, 95% CI 0.49 to 0.79, P<0.0001) were also reduced significantly. TXA usage did not increase risk of mortality, myocardial infarction, stroke, pulmonary embolism and renal dysfunction, but was associated with a significantly increase in seizure attack (RR 3.21, 95% CI 1.04 to 9.90, P =?0.04).The overall rate of seizure attack was 0.62%(21/3378) for patients using TXA and 0.15%(5/3406) for patients in the control group. In subgroup analysis, TXA was effective for both on-pump and off-pump surgeries. Topical application didn't reduce the need for transfusion requirement, while intravenous delivery no matter as bolus injection alone or bolus plus continuous infusion were effective. Intravenous high-dose TXA didn't further decrease transfusion rate compared with low-dose regimen, and increased the risk of seizure by 4.83 times. No patients in the low-dose group had seizure attack.ConclusionsTXA was effective in reducing transfusion requirement in all kinds of cardiac surgeries. Low-dose intravenous infusion was the most preferable delivery method which was as effective as high-dose regimen in reducing transfusion rate without increasing the risk of seizure.

Dataset Information

Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol).

Introduction

Methods/design

Ethics and dissemination

Publications

Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol).

Similar Datasets

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