The cost-effectiveness of tranexamic acid for treatment of postpartum hemorrhage: A systematic review.
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ABSTRACT: Background
Postpartum hemorrhage (PPH) is responsible for nearly one quarter of maternal deaths. A 2017 multicountry trial found that incorporating tranexamic acid (TXA) into the PPH management package was effective in reducing maternal death due to bleeding.Objective
To systematically review studies assessing the cost-effectiveness of tranexamic acid for PPH treatment.Search strategy
Nine databases were searched using variations of keywords 'tranexamic acid', 'postpartum hemorrhage' and 'cost effectiveness'.Selection criteria
Eligible studies were any type of economic or effectiveness evaluation studies on tranexamic acid for treating women with PPH.Data collection and analysis
Two reviewers independently screened citations and extracted data on cost effectiveness measures. Quality was assessed using the Consensus on Health Economic Criteria list.Main results
Four studies were included, of which two were abstracts. Three studies concluded that early administration of TXA was cost-saving or cost-effective. One abstract reported TXA was not cost-effective in the USA unless the probability of death due to hemorrhage is higher.Conclusion
Available evidence (four studies in three countries) suggests that this life-saving intervention may be below willingness to pay thresholds (cost-effective) or cost saving. Further studies conducted in different populations and settings are needed to inform health policy decision-making to reduce PPH-associated morbidity and mortality.
SUBMITTER: Aziz S
PROVIDER: S-EPMC8596845 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo review available data on tranexamic acid (TXA) plasma concentration needed to inhibit fibrinolysis and the time to achieve this concentration when giving TXA by different routes in humans. To identify ongoing trials assessing alternatives to intravenous TXA administration.MethodsWe updated two previous systematic reviews by searching MEDLINE, EMBASE, OviSP, and ISI Web of Science from database inception to July 2021. We also searched the WHO International Clinical Trials Registry Platform for ongoing trials to July 2021. Titles and abstracts were screened for relevant trials. Two reviewers independently reviewed and agreed the trials to be included.ResultsPlasma TXA concentrations over 10 mg/L provide near maximal inhibition of fibrinolysis, with concentrations over 5 mg/L providing partial inhibition. Oral TXA tablets take about 1 h to reach a plasma concentration of 5 mg/L in postpartum women. Studies in healthy volunteers and shocked trauma patients show that intramuscular TXA achieves a plasma level of over 10 mg/L within 15 min. One trial is ongoing to determine the pharmacokinetics of intramuscular and oral solution TXA in pregnant women.ConclusionIntramuscular TXA in healthy volunteers and shocked trauma patients reaches therapeutic concentration rapidly. Oral TXA tablets take too long to reach the minimum therapeutic concentration in postpartum women.
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Project description:BackgroundIn this meta-analysis, we aimed to update the clinical evidence regarding the efficacy and safety of TXA in the prevention of PPH.MethodsA literature search of PubMed, Scopus, Web of Science, Google Scholar, and Cochrane Library from inception until December 2022 was conducted. We included randomized controlled trials (RCTs) comparing TXA with a placebo among pregnant women. All relevant outcomes, such as total blood loss, the occurrence of nausea and/or vomiting, and changes in hemoglobin, were combined as odds ratios (OR) or mean differences (MD) in the meta-analysis models using STATA 17 MP.ResultsWe included 59 RCTs (18,649 patients) in this meta-analysis. For cesarean birth, TXA was favored over the placebo in reducing total blood loss (MD= -2.11 mL, 95%CI [-3.09 to -1.14], P < 0.001), and occurrence of nausea or/and vomiting (OR = 1.36, 95%CI [1.07 to 1.74], P = 0.01). For vaginal birth, the prophylactic use of TXA was associated with lower total blood loss, and higher occurrence of nausea and/or vomiting (MD= -0.89 mL, 95%CI [-1.47 to -0.31], OR = 2.36, 95%CI [1.32 to 4.21], P = 0.02), respectively. However, there were no differences between the groups in changes in hemoglobin during vaginal birth (MD = 0.20 g/dl, 95%CI [-0.07 to 0.48], P = 0.15). The overall risk of bias among the included studies varies from low to high risk of bias using ROB-II tool for RCTs.ConclusionsThis meta-analysis suggested that TXA administration is effective among women undergoing cesarean birth or vaginal birth in lowering total blood loss and limiting the occurrence of PPH. Further clinical trials are recommended to test its efficacy on high-risk populations.
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Project description:BackgroundOral tranexamic acid (TXA), if effective in reducing blood loss after delivery for women experiencing primary PPH, could be administered where parenteral administration is not feasible. This trial assessed the efficacy, safety, and acceptability of oral TXA when used as an adjunct to sublingual misoprostol to treat postpartum hemorrhage (PPH) following vaginal delivery.MethodsFrom October 2016 to January 2018, women presenting at four hospitals in Senegal and Vietnam for vaginal delivery were screened for enrollment in the trial. Women diagnosed with postpartum hemorrhage (defined as blood loss ≥700 ml) were randomized to receive either oral TXA (1950 mg) or placebo in addition to 800 mcg sublingual misoprostol. Postpartum blood loss was measured using a calibrated drape. Blood loss for all PPH cases was recorded for 2 h after administration of the drugs. The primary outcome measure was the proportion of women with bleeding controlled with the trial regimen without recourse to further treatment. Secondary outcomes including the rate of severe PPH, mean/median blood loss, use of additional uterotonics and/or interventions side effects, and acceptability were also recorded.ResultsOf the 258 women who received treatment for PPH, 128 received placebo and misoprostol and 130 received TXA and misoprostol. The proportion of women who had active bleeding controlled with trial drugs alone and no additional interventions was similar in both groups: 77(60.2%) placebo; 74 (56.9%) TXA, p = 0.59). Use of other interventions to control bleeding, including uterotonics, did not differ significantly between groups. Median blood loss at PPH diagnosis was 700 ml in both groups. Uterine atony alone or in addition to another cause contributed to over 90% of PPH cases reported (92.2% placebo vs. 91.5% TXA), other causes included perineal and cervical lacerations and retained placenta. Reports of side effects and acceptability were similar in the two groups.ConclusionAdjunct use of oral TXA with misoprostol to treat PPH resulted in similar clinical and acceptability outcomes when compared to treatment with misoprostol alone.Trial registrationThis trial was registered with ClinicalTrials.gov, number NCT02805426. Registered on 3 September 2016.
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Project description:Background/objectiveEffective hemostasis has the potential to reduce inflammation and pain, leading to potential benefits in the early rehabilitation of patients who undergo elbow arthrolysis. In the present study, we aim to assesse the effects of tranexamic acid (TXA) on elbow arthrolysis postoperative blood loss, patients' pain perception according to the visual analog scale (VAS), elbow range of motion (ROM), and complications.MethodsWe systematically searched PubMed, Web of Science, SCOPUS, and Cochrane Library. We included controlled trials, either randomized (RCT) or non-randomized studies of intervention (NRSI) comparing the effects of intravenous tranexamic acid (TXA) treatment with placebo/no treatment on postoperative blood loss, pain VAS score, elbow ROM, and complications, in patients who underwent open or closed elbow arthrolysis surgery.ResultsOne RCT, and three NRSIs met eligibility criteria. The meta-analysis determined that tranexamic acid application reduced drain output 34 mm on average (WMD: -34.00; 95% CI: -49.45, -18.55). There was a discrepancy among included articles in terms of intra-operative blood loss; although the study with the largest sample size (291 and 296 patients in the case and control groups, respectively) reported reduced intra-operative blood loss in patients who received TXA. The pooled estimation for the pain VAS score on the first day post-operatively indicates a reduction in pain among patients in the TXA group (WMD: -0.82; 95% CI: -1.36, -0.28). Results for ROM, and complications' rate such as hematoma and ulnar nerve palsy were not different between the two groups.ConclusionTXA may be beneficial to reduce elbow arthrolysis bleeding volume. However, it dose not seem to affect final elbow ROM and patients' pain score. Further high-quality clinical trials are needed to draw a robust conclusion on this topic.
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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.
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Project description:The use of tranexamic acid (TXA) in the treatment of trauma patients was relatively unexplored until the landmark Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage-2 (CRASH-2) trial in 2010 demonstrated a reduction in mortality with the use of TXA. Although this trial was a randomized, double-blinded, placebo-controlled study incorporating >20,000 patients, numerous limitations and weaknesses have been described. As a result, additional studies have followed, delineating the potential risks and benefits of TXA administration. A systematic review of the literature to date reveals a mortality benefit of early (ideally <1 hour and no later than 3 hours after injury) TXA administration in the treatment of severely injured trauma patients (systolic blood pressure <90 mm Hg, heart rate >110). Combined with abundant literature showing a reduction in bleeding in elective surgery, the most significant benefit may be administration of TXA before the patient goes into shock. Those trials that failed to show a mortality benefit of TXA in the treatment of hemorrhagic shock acknowledged that most patients received blood products before TXA administration, thus confounding the results. Although the use of prehospital TXA in the severely injured trauma patient will become more clear with the trauma studies currently underway, the current literature supports the use of prehospital TXA in this high-risk population. We recommend considering a 1 g TXA bolus en route to definitive care in high-risk patients and withholding subsequent doses until hyperfibrinolysis is confirmed by thromboelastography.
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