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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Objectives & BackgroundMany emergency medicine clinical trials have struggled to recruit to ‘time and target’ with investigators having to make a large additional effort or extend the time for recruitment. This study was performed to describe our experience in the use of a computer ‘app’ to facilitate the process of research subject identification and communication between the ED staff and the research team. Key questions were:1) Does the introduction of an iPad ‘app’ result in a greater rate of patient notification to the research team?2) Which type of notification method was most used?MethodsAn observational ‘before and after' study was performed where ED staff had the choice of using a telephone ‘research hotline', verbal notification, a sticky label on the clinical notes or an iPad app (in the second phase of the study). A ‘gold standard' was provided by a manual search of the notes of every patient who presented to the ED. We developed the specification for an ‘app’ that presented the trial entry criteria coupled with an easy embedded method of emailing the research team using only three ‘clicks'. The iPads were secured to walls in key locations (such as triage areas) and ED staff simply entered the patient's identification number and pressed ‘send' for a message to be emailed. We reviewed the method of patient notification for 3 months before and after the introduction of the iPad system.ResultsThere was a significant (Fisher's Exact Test. p<0.0001) increase in ‘real time' notification of patients to the research team from 18% to 33% after the introduction of the iPad app. The mode of notification also changed–with no use of the ‘research hotline' telephone number after the app system was introduced. The use of sticky labels and the number of verbal notifications was also greatly reduced (See table 1).ConclusionThere was a significant increase in the immediacy of communication after the introduction of the iPad app. This occurred without a large amount of input from the research team, and seemed to be due to the staff knowing a specific location for the system and the ease of use, with the whole process taking less than 20 seconds. ED staff seemed to prefer using the ‘app', as after it was introduced there was very little use of the well publicised ‘research hotline' phone number. Information and communications technology can aid in the timely identification of potential research subjects in emergency care.