Safety and efficacy of preoperative tranexamic acid in reducing intraoperative and postoperative blood loss in high-risk women undergoing cesarean delivery: a randomized controlled trial.
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ABSTRACT: Background
Objective to assess the value of preoperative tranexamic acid (TXA) in reduction of intraoperative and postoperative blood loss in high-risk cesarean delivery (CD).Methods
A double blind randomized controlled trial included 160 high risk women who underwent elective lower segment CD. They were equally randomized to receive either 1 g of TXA or placebo 15 min before surgery. The primary outcome was Intraoperative blood loss.Results
The estimated blood loss was significantly higher in the placebo group when compared to TXA group (896.81 ± 519.6 vs. 583.23 ± 379.62 ml, P < 0.001). Both postoperative hemoglobin and hematocrit were lower (9.2 ± 1.6 and 27.4 ± 4.1 vs. 10.1 ± 1.2 and 30.1 ± 3.4, P values < 0.001and 0.012 respectively) and their change percentages (15.41 vs. 7.11%, P < 0.001) were higher in the placebo group when compared to TXA one. The need for further ecbolics was higher in placebo group when compared to TXA group (46.25 vs. 13.75%, P < 0.001).Conclusion
Preoperative TXA is safe and effective in reducing blood loss during and after high-risk CD.Trial registration
ClincalTrial.gov ID: NCT03820206 .
SUBMITTER: Shalaby MA
PROVIDER: S-EPMC8919531 | biostudies-literature | 2022 Mar
REPOSITORIES: biostudies-literature
Publications
Safety and efficacy of preoperative tranexamic acid in reducing intraoperative and postoperative blood loss in high-risk women undergoing cesarean delivery: a randomized controlled trial.
Shalaby Mohamed A MA Maged Ahmed M AM Al-Asmar Amira A El Mahy Mohamed M Al-Mohamady Maged M Rund Nancy Mohamed Ali NMA
BMC pregnancy and childbirth 20220314 1
<h4>Background</h4>Objective to assess the value of preoperative tranexamic acid (TXA) in reduction of intraoperative and postoperative blood loss in high-risk cesarean delivery (CD).<h4>Methods</h4>A double blind randomized controlled trial included 160 high risk women who underwent elective lower segment CD. They were equally randomized to receive either 1 g of TXA or placebo 15 min before surgery. The primary outcome was Intraoperative blood loss.<h4>Results</h4>The estimated blood loss was s ...[more]
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Project description:BackgroundStroke is a devastating and potentially preventable complication of cardiac surgery. Tranexamic acid (TXA) is a commonly antifibrinolytic agent in cardiac surgeries with cardiopulmonary bypass (CPB), however, there is concern that it might increase incidence of stroke after cardiac surgery. In this retrospective study, we investigated whether TXA usage could increase postoperative stroke in cardiac surgery.MethodsA retrospective study was conducted from January 1, 2010, to December 31, 2015, in 2,016 patients undergoing cardiac surgery, 664 patients received intravenous TXA infusion and 1,352 patients did not receive any antifibrinolytic agent. Univariate and propensity-weighted multivariate regression analysis were applied for data analysis.ResultsIntraoperative TXA administration was associated with postoperative stroke (1.7% vs. 0.5%; adjusted OR, 4.11; 95% CI, 1.33 to 12.71; p = 0.014) and coma (adjusted OR, 2.77; 95% CI, 1.06 to 7.26; p = 0.038) in cardiac surgery. As subtype analysis was performed, TXA administration was still associated with postoperative stroke (1.7% vs. 0.3%; adjusted OR, 5.78; 95% CI, 1.34 to 27.89; p = 0.018) in patients undergoing valve surgery or multi-valve surgery only, but was not associated with postoperative stroke (1.7% vs. 1.3%; adjusted OR, 5.21; 95% CI, 0.27 to 101.17; p = 0.276) in patients undergoing CABG surgery only. However, TXA administration was not associated with postoperative mortality (adjusted OR, 1.31; 95% CI, 0.56 to 3.71; p = 0.451), seizure (adjusted OR, 1.13; 95% CI, 0.42 to 3.04; p = 0.816), continuous renal replacement therapy (adjusted OR, 1.36; 95% CI, 0.56 to 3.28; p = 0.495) and resternotomy for postoperative bleeding (adjusted OR, 1.55; 95% CI, 0.55 to 4.30; p = 0.405). No difference was found in postoperative ventilation time (adjusted B, -1.45; SE, 2.33; p = 0.535), length of intensive care unit stay (adjusted B, -0.12; SE, 0.25; p = 0.633) and length of hospital stay (adjusted B, 0.48; SE, 0.58; p = 0.408).ConclusionsBased on the 5-year experience of TXA administration in cardiac surgery with CPB, we found that postoperative stroke was associated with intraoperative TXA administration in patients undergoing cardiac surgery, especially in those undergoing valve surgeries only. This study may suggest that TXA should be administrated according to clear indications after evaluating the bleeding risk in patients undergoing cardiac surgery, especially in those with high stroke risk.
| S-EPMC5446127 | biostudies-literature
Project description:ImportanceBlood loss from surgical procedures is a major issue worldwide as the demand for blood products is increasing. Tranexamic acid is an antifibrinolytic agent commonly used to reduce intraoperative blood loss.ObjectiveTo systematically examine the role of tranexamic acid in reducing intraoperative blood loss and postoperative edema and ecchymosis among patients undergoing primary elective rhinoplasty.Data sourcesA systematic review and meta-analysis was undertaken in an academic medical setting using Medline, Embase, and Google Scholar from inception to June 30, 2018. All references of included articles were screened for potential inclusion. The search was mapped to Medical Subject Headings, and the following terms were used to identify potential articles: reconstruction or rhinoplasty and tranexamic acid or anti-fibrinolysis or antifibrinolysis and bleeding or ecchymosis or bruising or edema or complications.Study selectionThe population of interest consisted of adult patients undergoing primary elective rhinoplasty. The intervention was the use of tranexamic acid. The control group was composed of patients receiving a placebo. Primary outcomes were intraoperative blood loss and postoperative edema and ecchymosis. In vitro or animal studies were excluded, and only English-language articles were included.Data extraction and synthesisThe PRISMA guidelines were followed, and articles were assessed using the Cochrane Collaboration's tool for assessing risk of bias and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines. Random-effects meta-analysis was performed to determine the overall effect size.Main outcomes and measuresThe primary outcomes were intraoperative blood loss and postoperative edema and ecchymosis.ResultsFive studies (comprising 332 patients) were included in the qualitative analysis, all of which were randomized clinical trials published within the past 5 years. The mean (SD) patient age was 27 (7) years (age range, 16-42 years), while the mean (SD) sample size was 66 (19) (range, 50-96). Meta-analysis of 4 studies (271 patients) indicated that tranexamic acid treatment resulted in a mean reduction in intraoperative blood loss of -41.6 mL (95% CI, -69.8 to -13.4 mL) compared with controls (P = .004). Three studies indicated that postoperative edema and ecchymosis were reduced with tranexamic acid treatment compared with controls; however, there was no significant difference compared with corticosteroid use. Four studies were considered of high methodological quality, with a low risk of bias. The overall quality of evidence was high.Conclusions and relevanceTranexamic acid has the ability to significantly reduce intraoperative blood loss and postoperative edema and ecchymosis among patients undergoing primary elective rhinoplasty.Level of evidence4.
| S-EPMC6537831 | biostudies-literature
Project description:BackgroundProphylactic use of tranexamic acid at the time of cesarean delivery has been shown to decrease the calculated blood loss, but the effect on the need for blood transfusions is unclear.MethodsWe randomly assigned patients undergoing cesarean delivery at 31 U.S. hospitals to receive either tranexamic acid or placebo after umbilical-cord clamping. The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days post partum, whichever came first. Key secondary outcomes were estimated intraoperative blood loss of more than 1 liter (prespecified as a major secondary outcome), interventions for bleeding and related complications, the preoperative-to-postoperative change in the hemoglobin level, and postpartum infectious complications. Adverse events were assessed.ResultsA total of 11,000 participants underwent randomization (5529 to the tranexamic acid group and 5471 to the placebo group); scheduled cesarean delivery accounted for 50.1% and 49.2% of the deliveries in the respective groups. A primary-outcome event occurred in 201 of 5525 participants (3.6%) in the tranexamic acid group and in 233 of 5470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07; P = 0.19). Estimated intraoperative blood loss of more than 1 liter occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI, 0.79 to 1.05). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82 to 0.97); the change in the hemoglobin level was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI, 1.02 to 1.61). The frequencies of thromboembolic events and other adverse events were similar in the two groups.ConclusionsProphylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT03364491.).
| S-EPMC10200294 | biostudies-literature
Project description:Essentials Tranexamic acid (TXA) is an antifibrinolytic drug used to reduce bleeding. Assaying plasmin generation (PG) in plasma detects clinically relevant TXA levels in vitro and ex vivo. 3.1-16.2 µg/mL TXA half-maximally inhibits PG in plasma from women undergoing cesarean delivery. PG velocity shows the strongest dose-relationship at low TXA concentrations (≤10 µg/mL). ABSTRACT: Background Tranexamic acid (TXA) is used to reduce bleeding. TXA inhibits plasmin(ogen) binding to fibrin and reduces fibrinolysis. TXA antifibrinolytic activity is typically measured by clot lysis assays; however, effects on plasmin generation (PG) are unclear due to a lack of tools to measure PG in plasma. Aims Develop an assay to measure PG kinetics in human plasma. Determine effects of TXA on PG and compare with fibrinolysis measured by rotational thromboelastometry (ROTEM). Methods We characterized effects of plasminogen, tissue plasminogen activator, fibrinogen, and α2 -antiplasmin on PG in vitro. We also studied effects of TXA on PG in plasma from 30 pregnant women administered intravenous TXA (5, 10, or 15 mg/kg) during cesarean delivery. PG was measured by calibrated fluorescence. PG parameters were compared with TXA measured by mass spectrometry and ROTEM of whole blood. Results The PG assay is specific for plasmin and sensitive to tissue plasminogen activator, fibrin(ogen), and α2 -antiplasmin. Addition of TXA to plasma in vitro dose dependently prolonged the clot lysis time and delayed and reduced PG. For all doses of TXA administered intravenously, the PG assay detected delayed time-to-peak (≤3 hours) and reduced the velocity, peak, and endogenous plasmin potential (≤24 hours) in plasma samples obtained after infusion. The PG time-to-peak, velocity, and peak correlated significantly with TXA concentration and showed less variability than the ROTEM lysis index at 30 minutes or maximum lysis. Conclusions The PG assay detects pharmacologically relevant concentrations of TXA administered in vitro and in vivo, and demonstrates TXA-mediated inhibition of PG in women undergoing cesarean delivery.
| S-EPMC7875467 | biostudies-literature
Project description:BackgroundPreoperative anxiety affects 60 to 80% of patients who are candidates for surgery. Reducing preoperative anxiety can improve surgical outcomes, shorten hospital stays, and minimize disruptions in lifestyle. Having information affects people ability to identify important points and improve their understanding, and lack of information causes fear and anxiety, which negatively affects decision-making. Studies have shown that the intervention of education before cesarean section has a beneficial effect on women anxiety level. Providing information before surgery can reduce patients' anxiety. This study was conducted to determine the effect of information video before elective cesarean delivery on preoperative anxiety and post-operative satisfaction.MethodsThe search for relevant studies was systematically conducted in PubMed, Scopus, Web of Science, Cochrane Library, SID (Persian database), and Google Scholar (search engine) until July 4, 2023, in both English and Persian languages. The revised tool for assessing the risk of bias in randomized trials (RoB 2.0) and ROBIN-I were used to evaluate the risk of bias, and heterogeneity was assessed using I². In cases of high heterogeneity, a random effects model was used instead of a fixed effects model. Subgroup analysis was performed based on the duration of the video, and the type of intervention for the primary outcome. Sensitivity analysis was conducted based on the type of study. A random-effects meta-regression analysis was conducted to identify potential sources of high heterogeneity for preoperative anxiety. The certainty of the evidence was assessed using GRADE.ResultsA total number of 557 articles were found in databases. Three hundred sixty-eight studies were screened based on their titles, abstracts, and full texts. Of these, 16 studies were assessed for eligibility, and 7 were excluded. Ultimately, nine papers were included. Meta-analysis results showed that the information video before elective cesarean delivery compared to control group may have little or no effect on preoperative anxiety, but the evidence is uncertain (SMD - 0.22, 95% CI -0.51 to 0.06, 9 trials, 1020 participants, I2 = 80%; very low-certainty evidence). Also, it probably increases the post-operative satisfaction (SMD 0.26, 95% CI 0.10 to 0.42, 5 trials, 618 participants, I2 = 0%; Moderate-certainty evidence). The random effect meta-regression analyses indicated a significant correlation between the mean age of the intervention group (β = 0.137, P < 0.001) and the mean age of the control group (β = 0.150, P = 0.0246) with effect size.ConclusionThis study found that watching an informational video prior to elective cesarean delivery resulted in a decrease in preoperative anxiety. However, it is important to note that the reduction was not statistically significant, and there was a high level of inconsistency among the results. Nonetheless, the intervention did lead to an improvement in women's post-operative satisfaction. To determine the optimal time duration and content type of informational videos, further studies with more appropriate methodology are necessary.
| S-EPMC10759807 | biostudies-literature
Project description: Not available
| S-EPMC9373598 | biostudies-literature
Project description:IntroductionTranexamic acid (TXA) has been proven to prevent thrombolysis and reduce bleeding and blood transfusion requirements in various surgical settings. However, the optimal dose of TXA that effectively reduce intraoperative bleeding and blood product infusion in patients undergoing neurosurgical resection of meningioma with a diameter ≥ 5 cm remains unclear.MethodsThis is a single-center, randomized, double-blinded, paralleled-group controlled trial. Patients scheduled to receive elective tumor resection with meningioma diameter ≥ 5 cm will be randomly assigned the high-dose TXA group, the low-dose group, and the placebo. Patients in the high-dose TXA group will be administered with a loading dose of 20 mg/kg TXA followed by continuous infusion TXA at a rate of 5 mg/kg/h. In the low-dose group, patients will receive the same loading dose of TXA followed by a continuous infusion of normal saline. In the control group, patients will receive an identical volume of normal saline. The primary outcome is the estimated intraoperative blood loss calculated using the following formula: collected blood volume in the suction canister (mL)-the volume of flushing (mL) + the volume from the gauze tampon (mL). Secondary outcomes include calculated intraoperative blood loss, intraoperative coagulation function assessed using thromboelastogram (TEG), intraoperative cell salvage use, blood product infusion, and other safety outcomes.DiscussionPreclinical studies suggest that TXA could reduce intraoperative blood loss, yet the optimal dose was controversial. This study is one of the early studies to evaluate the impact of intraoperative different doses infusion of TXA on reducing blood loss in neurological meningioma patients.Trial registrationClinicalTrials.gov, NCT05230381. Registered on February 8, 2022.
| S-EPMC10470952 | biostudies-literature
Project description:ObjectivesThe aim of this study was to determine whether orthognathic surgery is associated with any complications, and what type of complications may occur.Materials and methodsData were obtained using PubMed (MEDLINE), ISI Web of Knowledge, Ovid, Cochrane Library, Embase Library, and an additional manual search. The titles and abstracts of the electronic search results were screened and evaluated by two observers for eligibility according to the inclusion and exclusion criteria.ResultsA total of 1924 articles were identified, and we retained 44 articles for the final analysis. The Prisma diagram flowchart demonstrates our selection scheme. For the purpose of this study, the Cochrane data extraction form was modified. One review author extracted data from the included studies, and the second author checked all of the forms. The hierarchy of evidence classification from the UK NHS Centre for Reviews and Dissemination was used to assess the level of evidence for the retrieved studies.ConclusionsAn evaluation of the obtained studies revealed the existence of a large number of varied complications associated with orthognathic surgery procedures.Clinical relevanceOral and maxillofacial surgeons, orthodontists, and the surgical team need to prevent such complications during preoperative, intraoperative, and postoperative periods to increase the safety of orthognathic surgery procedures. This review was registered on http://www.crd.york.ac.uk/PROSPERO as CRD42013004711.
| S-EPMC4434857 | biostudies-literature
Project description:BackgroundTranexamic acid has been increasingly used for blood conservation in cardiac surgery. However, the evidence supporting the routine use of tranexamic acid in Chinese pediatric patients undergoing cardiac surgery remains weak. This meta-analysis aimed to systematically review the efficacy of tranexamic acid when applying to Chinese pediatric patients undergoing cardiac surgery.ParticipantsChinese pediatric patients undergoing cardiac surgery.InterventionsTranexamic acid or control drugs (saline/blank).MethodsPUBMED, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP Data till May 4, 2021, database search was updated on August 1. Primary outcomes of interest included postoperative bleeding, allogeneic transfusion, and reoperation for bleeding. Secondary outcomes of interest included postoperative recovery. For continuous/dichotomous variables, treatment effects were calculated as weighted mean difference (WMD)/odds ratio and 95% confidence interval.ResultsA database search yielded 15 randomized controlled trials including 1641 patients, where 8 studies were allocated into non-cyanotic congenital group, 5 were allocated into cyanotic congenital group, and the other 2 were allocated into combined cyanotic/non-cyanotic group. This meta-analysis demonstrate that tranexamic acid administration can reduce the postoperative 24 hours blood loss in non-cyanotic, cyanotic, and combined cyanotic/non-cyanotic patients, the red blood cell transfusion in non-cyanotic and cyanotic patients, and the fresh frozen plasma transfusion in non-cyanotic and combined cyanotic/non-cyanotic patients.ConclusionThis meta-analysis demonstrates that tranexamic acid is highly effective in reducing the blood loss in Chinese pediatric cardiac surgery, but it behaves poorly when it comes to the transfusion requirement. To further confirm this, more well-designed and adequately-powered randomized trials are needed.
| S-EPMC8896488 | biostudies-literature
Project description:BackgroundPostoperative delirium is a common complication that hinders recovery after surgery. Intraoperative electroencephalogram suppression has been linked to postoperative delirium, but it is unknown if this relationship is causal or if electroencephalogram suppression is merely a marker of underlying cognitive abnormalities. The hypothesis of this study was that intraoperative electroencephalogram suppression mediates a nonzero portion of the effect between preoperative abnormal cognition and postoperative delirium.MethodsThis is a prespecified secondary analysis of the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) randomized trial, which enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018. Patients were randomized to electroencephalogram-guided anesthesia or usual care. Preoperative abnormal cognition was defined as a composite of previous delirium, Short Blessed Test cognitive score greater than 4 points, or Eight Item Interview to Differentiate Aging and Dementia score greater than 1 point. Duration of intraoperative electroencephalogram suppression was defined as number of minutes with suppression ratio greater than 1%. Postoperative delirium was detected via Confusion Assessment Method or chart review on postoperative days 1 to 5.ResultsAmong 1,113 patients, 430 patients showed evidence of preoperative abnormal cognition. These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001). Of this 17.2% total effect size (99.5% CI, 9.3 to 25.1%), an absolute 2.4% (99.5% CI, 0.6 to 4.8%) was an indirect effect mediated by electroencephalogram suppression, while an absolute 14.8% (99.5% CI, 7.2 to 22.5%) was a direct effect of preoperative abnormal cognition. Randomization to electroencephalogram-guided anesthesia did not change the mediated effect size (P = 0.078 for moderation).ConclusionsA small portion of the total effect of preoperative abnormal cognition on postoperative delirium was mediated by electroencephalogram suppression. Study precision was too low to determine if the intervention changed the mediated effect.
| S-EPMC7228853 | biostudies-literature