Tranexamic acid for upper gastrointestinal bleeding

Abstract

Background Tranexamic acid reduces haemorrhage through its antifibrinolytic effects. In a previous version of the present review, we found that tranexamic acid may reduce mortality. This review includes updated searches and new trials. Objectives To assess the effects of tranexamic acid versus no intervention, placebo or other antiulcer drugs for upper gastrointestinal bleeding. Search methods We updated the review by performing electronic database searches (Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index) and manual searches in July 2014. Selection criteria Randomised controlled trials, irrespective of language or publication status. Data collection and analysis We used the standard methodological procedures of the The Cochrane Collaboration. All-cause mortality, bleeding and adverse events were the primary outcome measures. We performed fixed-effect and random-effects model meta-analyses and presented results as risk ratios (RRs) with 95% confidence intervals (CIs) and used I² as a measure of between-trial heterogeneity. We analysed tranexamic acid versus placebo or no intervention and tranexamic acid versus antiulcer drugs separately. To analyse sources of heterogeneity and robustness of the overall results, we performed subgroup, sensitivity and sequential analyses. Main results We included eight randomised controlled trials on tranexamic acid for upper gastrointestinal bleeding. Additionally, we identified one large ongoing pragmatic randomised controlled trial from which data are not yet available. Control groups were randomly assigned to placebo (seven trials) or no intervention (one trial). Two trials also included a control group randomly assigned to antiulcer drugs (lansoprazole or cimetidine). The included studies were published from 1973 to 2011. The number of participants randomly assigned ranged from 47 to 216 (median 204). All trials reported mortality. In total, 42 of 851 participants randomly assigned to tranexamic 1 Tranexamic acid for upper gastrointestinal bleeding (Review)

Searching ClinicalTrials.gov and the International Clinical Trials Registry Platform to inform systematic reviews: what are the optimal search approaches?

“…Following this pilot investigation, six additional CSRs [11][12][13][14][15][16] were identified by searching for ''New'' reviews in the 2012 issue 1 version of the Cochrane Database of Systematic Reviews (CDSR), and their included trials were extracted as well. To identify the trials in the registers, their bibliographic details were collated into an Excel spreadsheet.…”

“…An example of an adapted sensitive strategy for one review [13] for the two interfaces in the two resources is shown in Table 1. { These four different search approaches were tested in ClinicalTrials.gov and ICTRP for each of the { Although five of the six systematic reviews reported searching at least one of the trials registries [11,[13][14][15][16], only one review [15] provided a search strategy for a registry. Therefore, the MEDLINE search strategies from the remaining reviews were modified for use in searching the trials resources.…”

“…The eight systematic reviews addressed a variety of interventions and conditions: & anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion [9], & preoperative autologous donation for minimising perioperative allogeneic blood transfusion [10], & parenteral versus oral iron therapy for adults and children with chronic kidney disease [11], & intracutaneous or subcutaneous sterile water injection compared with blinded controls for pain management in labour [12], & intramedullary nailing for tibial shaft fractures in adults [13], & tranexamic acid for upper gastrointestinal bleeding [14], & intravesical gemcitabine for non-muscle invasive bladder cancer [15], and & continuous glucose monitoring systems for type 1 diabetes mellitus [16].…”

“…The remaining 7 CSRs varied in terms of the proportion of their included studies that could be identified in the registers. In ClinicalTrials .gov, the number of included studies varied between 0 out of 7 for 2 reviews [12,14] and 8 out of 22 (36.36%) for 1 review [15]. In ICTRP, the number of included studies varied between 0 out of 7 for 2 reviews [12,14] and 12 out of 22 (54.55%) for 1 review [16].…”

“…In ClinicalTrials .gov, the number of included studies varied between 0 out of 7 for 2 reviews [12,14] and 8 out of 22 (36.36%) for 1 review [15]. In ICTRP, the number of included studies varied between 0 out of 7 for 2 reviews [12,14] and 12 out of 22 (54.55%) for 1 review [16]. The reviews for which no included studies could be located in either resource were a review of sterile water injection for pain management in labor [12] and a review of tranexamic acid for upper gastrointestinal bleeding [14].…”