Comparison of the efficacy of intravenous tranexamic acid with and without topical administration versus placebo in urgent endoscopy rate for acute gastrointestinal bleeding: A double-blind randomized controlled trial

Tavakoli, Nader; Mokhtare, Marjan; Agah, Shahram; Azizi, Ali; Masoodi, Mohsen; Amiri, Hasan Ashrafian; Sheikhvatan, Mehrdad; Syedsalehi, Bahare; Behnam, Behdad; Arabahmadi, Mehran; Mehrazi, Maryam

doi:10.1177/2050640617714940

Cited by 23 publications

(33 citation statements)

References 33 publications

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“…Three of the included trials 12‐14 had been published after the 2014 meta‐analysis 11 . In 10 of the included studies, 12,13,22‐29 patients were randomised to tranexamic acid (n = 1071) or placebo (n = 942). In the eleventh study 14 which was the only paediatric study, patients were randomised to tranexamic acid or epinephrine.…”

Section: Resultsmentioning

confidence: 99%

“…Since the paediatric study had a different comparator from all the other studies, it was not included in the meta‐analyses. Five of the trials included patients with variceal and nonvariceal bleeding 24‐26,28,29 and six trials included only patients with nonvariceal bleeding 12‐14,22,23,27 …”

Section: Resultsmentioning

confidence: 99%

“…With the exception of one trial, 23 all the included trials performed upper gastrointestinal endoscopy for participants in accordance with current recommendations 30 . Eight trials 12‐14,22,25‐27,29 performed endoscopy within 24 hours, and two trials 24,28 did not specify the timing of endoscopy. Most of the studies except one 13 did not state the proportion of patients who might have required endoscopic interventions.…”

Section: Resultsmentioning

confidence: 99%

“…It was administered solely intravenously in one trial, 27 and orally in two trials 23,29 . Tranexamic acid was given via nasogastric tube in two trials, 12,25 and via either intravenous or nasogastric tube in two trials 13,22 . In the single paediatric study, 14 tranexamic acid was injected directly into the submucosa of peptic ulcer margins at endoscopy.…”

Section: Resultsmentioning

confidence: 99%

“…A meta‐analysis published in 2014 found that tranexamic acid may have a beneficial effect on mortality, but the authors called for additional research on the topic due to some methodological weaknesses of the primary studies 11 . Following the publication of this meta‐analysis, three new randomised controlled trials (RCTs) have been published 12‐14 . In view of the recently published trials, and the inconclusive nature of previous reports, we performed an up‐to‐date comprehensive systematic review and meta‐analysis to evaluate the effects of tranexamic acid in upper gastrointestinal bleeding.…”

Section: Introductionmentioning

confidence: 99%

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Systematic review with meta‐analysis: the efficacy of tranexamic acid in upper gastrointestinal bleeding

Twum-Barimah

Abdelgadir

Gordon

et al. 2020

Aliment Pharmacol Ther

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Background: Upper gastrointestinal bleeding is a common medical emergency associated with substantial mortality. Tranexamic acid may be effective for reducing mortality in upper gastrointestinal bleeding. Aim: To examine the effects of tranexamic acid in upper gastrointestinal bleeding by systematic review and meta-analysis. Methods: We searched PubMed, EMBASE, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL) and other relevant websites for randomised controlled trials investigating the effect of tranexamic acid published from inception to December 10, 2019. The primary outcome of interest was mortality. Estimates of effect were pooled with a random effects model. Quality of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach.Results: The search identified 1572 citations. Eleven trials comprising 2076 patients were eligible for inclusion. Of these, 10 trials (2013 patients) compared tranexamic acid with placebo. Risk of death was significantly reduced in patients who received tranexamic acid compared with those who received placebo (RR 0.59, 95% CI 0.43-0.82, P = 0.001) with no significant heterogeneity noted among studies (I 2 = 0%, P = 0.81). The GRADE assessment rated the quality of the evidence for mortality as moderate due to risk of bias. There were no statistically significant differences between tranexamic acid and placebo for the prevention of re-bleeding, need for surgical interventions, need for blood transfusions or frequency of thromboembolic events. Conclusions:Moderate-quality evidence shows that tranexamic acid is superior to placebo for the reduction in mortality in patients with upper gastrointestinal bleeding. While our findings lend further support to the use of tranexamic acid for treating patients with upper gastrointestinal bleeding, additional higher-quality trials are needed. | 1005 TWUM-BARIMAH eT Al. a Assumed risk with placebo was derived from the total number of cases in the placebo group over the total number of patients in that group. bThe risk difference with the tranexamic acid group (and its 95% CI) is based on the assumed risk in the placebo group and the relative effect of tranexamic acid (and its 95% CI).c Serious risk of bias due to lack of allocation concealment in some studies.d Serious imprecision due to confidence interval including benefit and harm.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Systematic review with meta‐analysis: the efficacy of tranexamic acid in upper gastrointestinal bleeding

Twum-Barimah

Abdelgadir

Gordon

et al. 2020

Aliment Pharmacol Ther

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Association of Intravenous Tranexamic Acid With Thromboembolic Events and Mortality

et al. 2021

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IMPORTANCE Tranexamic acid (TXA) is an efficient antifibrinolytic agent; however, concerns remain about the potential adverse effects, particularly vascular occlusive events, that may be associated with its use.OBJECTIVE To examine the association between intravenous TXA and total thromboembolic events (TEs) and mortality in patients of all ages and of any medical disciplines.DATA SOURCE Cochrane Central Register of Controlled Trials and MEDLINE were searched for eligible studies investigating intravenous TXA and postinterventional outcome published between 1976 and 2020.STUDY SELECTION Randomized clinical trials comparing intravenous TXA with placebo/no treatment. The electronic database search yielded a total of 782 studies, and 381 were considered for full-text review. Included studies were published in English, German, French, and Spanish. Studies with only oral or topical tranexamic administration were excluded.DATA EXTRACTION AND SYNTHESIS Meta-analysis, subgroup and sensitivity analysis, and meta-regression were performed. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. MAIN OUTCOMES AND MEASURES Vascular occlusive events and mortality.RESULTS A total of 216 eligible trials including 125 550 patients were analyzed. Total TEs were found in 1020 (2.1%) in the group receiving TXA and 900 (2.0%) in the control group. This study found no association between TXA and risk for total TEs (risk difference = 0.001; 95% CI, −0.001 to 0.002; P = .49) for venous thrombosis, pulmonary embolism, venous TEs, myocardial infarction or ischemia, and cerebral infarction or ischemia. Sensitivity analysis using the risk ratio as an effect measure with (risk ratio = 1.02; 95% CI, 0.94-1.11; P = .56) and without (risk ratio = 1.03; 95% CI, 0.95-1.12; P = .52) studies with double-zero events revealed robust effect size estimates. Sensitivity analysis with studies judged at low risk for selection bias showed similar results. Administration of TXA was associated with a significant reduction in overall mortality and bleeding mortality but not with nonbleeding mortality. In addition, an increased risk for vascular occlusive events was not found in studies including patients with a history of thromboembolism. Comparison of studies with sample sizes of less than or equal to 99 (risk difference = 0.004; 95% CI, −0.006 to 0.014; P = .40), 100 to 999 (risk difference = 0.004; 95% CI, −0.003 to 0.011; P = .26), and greater than or equal to 1000 (risk difference = −0.001; 95% CI, −0.003 to 0.001; P = .44) showed no association between TXA and incidence of total TEs. Meta-regression of 143 intervention groups showed no association between TXA dosing and risk for venous TEs (risk difference, −0.005; 95% CI, −0.021 to 0.011; P = .53).CONCLUSIONS AND RELEVANCE Findings from this systematic review and meta-analysis of 216 studies suggested that intravenous TXA, irrespective of dosing, is not associated with increased risk of any TE. These results help clarify the incidence of...

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Transfusion strategies in bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine

et al. 2021

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Purpose: To develop evidence-based clinical practice recommendations regarding transfusion practices and transfusion in bleeding critically ill adults. Methods:A taskforce involving 15 international experts and 2 methodologists used the GRADE approach to guideline development. The taskforce addressed three main topics: transfusion support in massively and non-massively bleeding critically ill patients (transfusion ratios, blood products, and point of care testing) and the use of tranexamic acid. The panel developed and answered structured guideline questions using population, intervention, comparison, and outcomes (PICO) format. Results:The taskforce generated 26 clinical practice recommendations (2 strong recommendations, 13 conditional recommendations, 11 no recommendation), and identified 10 PICOs with insufficient evidence to make a recommendation. Conclusions:This clinical practice guideline provides evidence-based recommendations for the management of massively and non-massively bleeding critically ill adult patients and identifies areas where further research is needed.

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Comparison of the efficacy of intravenous tranexamic acid with and without topical administration versus placebo in urgent endoscopy rate for acute gastrointestinal bleeding: A double-blind randomized controlled trial

Abstract: Our results showed that the antifibrinolytic properties of TXA can aid in changing an urgent endoscopy to an elective procedure, with better outcomes for both physicians and patients.

Cited by 23 publications

References 33 publications

Systematic review with meta‐analysis: the efficacy of tranexamic acid in upper gastrointestinal bleeding

Systematic review with meta‐analysis: the efficacy of tranexamic acid in upper gastrointestinal bleeding

Association of Intravenous Tranexamic Acid With Thromboembolic Events and Mortality

Transfusion strategies in bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine

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