Background Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. Methods We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0•9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0•9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.

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The unmet need for pediatric surgery incurs enormous health and economic consequences globally, predominantly shouldered by Sub-Saharan Africa (SSA) where children comprise almost half of the population. Lack of economic impact data on improving pediatric surgical infrastructure in SSA precludes informed allocation of limited resources towards the most cost-effective interventions to bolster global surgery for children. We assessed the cost-effectiveness of installing and maintaining a pediatric operating room in a hospital in Nigeria with a pre-existing pediatric surgical service by constructing a decision tree model of pediatric surgical delivery at this facility over a year, comparing scenarios before and after the installation of two dedicated pediatric operating rooms (ORs), which were funded philanthropically. Health outcomes measured in disability-adjusted life years (DALYs) averted were informed by the hospital’s operative registry and prior literature. A societal perspective included costs incurred by the hospital system, charity, and patients’ families. Costs were annualized and reported in 2021 United States dollars ($). The incremental cost-effectiveness ratios (ICERs) of the annualized OR installation were presented from charity and societal perspectives. One-way and probabilistic sensitivity analyses were performed. We found that the installation and maintenance of two pediatric operating rooms averted 1145 DALYs and cost $155,509 annually. Annualized OR installation cost was $87,728 (56% of the overall cost). The ICER of the OR installation was $152 per DALY averted (95% uncertainty interval [UI] 147-156) from the societal perspective, and $77 per DALY averted (95% UI 75-81) from the charity perspective. These ICERs were well under the cost-effectiveness threshold of the country’s half-GDP per capita in 2020 ($1043) and remained cost-effective in one-way and probabilistic sensitivity analyses. Installation of additional pediatric operating rooms in SSA with pre-existing pediatric surgical capacity is therefore very cost-effective, supporting investment in children’s global surgical infrastructure as an economically sound intervention.

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