Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

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. Findings: Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82–1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98). Interpretation: We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial

Development and evaluation of a low-fidelity medication administration simulation that generates error as a salient learning experience for first-year nursing students over the long-term

Nurses are taught protocolised checking procedures as the foundation method for safe medication administration practice. However, medication administration occurs in the complex clinical environment and medication administration error is endemic in clinical practice. As a consequence, nurses need further support to administer medications safely. Simulation education is widely used in nurse education and making an error in simulation is one potential method to make salient the importance of protocolised checking procedures in clinical practice. The purpose of this study was to determine if a low-fidelity medication administration simulation which generated error underlined the importance of checking procedures and provided a salient, effective and sufficiently realistic learning experience for nursing students over the long-term.The study was conducted over a three-year period between April 2007 and April 2010. A low-fidelity online medication administration simulation was developed which replicated a hospital-based medication round using paper charts. A preliminary titration study was completed to titrate variables from clinical practice to generate a a ‘right drug, wrong patient’ error was generated if the ‘five rights’ were not applied. In the comparative study, 124 first-year nursing students were randomly allocated to one of three teaching sessions: the simulation session or one of two identical classroom-based sessions in which students made an error external to the simulation but was actively linked to medication administration error. In one of these sessions, participants were informed about the simulation, its underlying theory and rates of error generated. All participants completed a post session questionnaire investigating the impact of their learning experience. In the long-term qualitative interview study, 12 simulation session participants completed qualitative interviews two-years later about their experience of using the simulation.35% of participants made an error in the simulation. The results of the questionnaire indicated that a combination of the simulation and the classroom-based session comprised the most effective learning format. The majority of qualitative interview study participants considered the simulation and the active experience of error to be a valuable and realistic learning experience. It reinforced the importance of the five rights and the potential risk of error if they are not applied.The active experience of error in the simulation underlined the importance of the five rights and generated affect to provide an effective learning experience which was salient over the long-term. The active experience of error made the simulation sufficiently realistic. Error can make lower-fidelity simulations more realistic and salient over the long-term. Error should be transformed from a useful but passive by-product into an active component of the simulation learning approach

“The damage I could do…”– Qualitative evaluation of a low-fidelity medication administration simulation that generates error as a learning experience for pre-registration nursing students

Background: In recent years, nurse education has emphasised the development of high cost, high-fidelity simulations because they are considered to provide a more realistic learning experience. Integral is the facility to commit and learn from error. Error may provide a mechanism to make low cost, low-fidelity simulations more psychologically realistic and salient. We developed a web based medication administration simulation which included all essential cognitive elements of medication administration task, but was “low-fidelity” in engineering terms of its portrayal of the physical world. The simulation incorporated conditions designed to generate high rates of medication administration error. The purpose of this study was to determine if the low cost low-fidelity simulation provided a salient, effective and psychologically realistic learning experience for pre-registration nursing students over the long term.Methods: Individual qualitative interviews were conducted with 12 pre-registration nursing students, from one UK university, from a group of 49 students who had received the simulation as trial participants 2-years previously. The interviews were analysed using thematic analysis.Results: Most participants were able to reflect on their experiences of the simulation in depth, and considered the simulation to be a valuable component to their learning. The simulation encouraged students to question their practice and highlighted their vulnerability to medication administration error. It reinforced both the importance of completing checking procedures and the potential consequences of making an error in practice. Most students believed the low- fidelity simulation provided a psychologically realistic representation of medication administration, which was underpinned by the negative emotional reactions to making an error, for example, guilt.Conclusions: Low-fidelity web based simulations can provide a sufficiently realistic psychological representation of medication administration to produce a salient, effective learning experience over the long-term. Low-fidelity simulations can provide a low cost alternative to high-fidelity simulations. Making error in a simulation should be transformed from a useful but passive by-product into an active component of the simulation learning approach. <br/

Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

BackgroundTranexamic 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.MethodsWe 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.FindingsBetween July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82–1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98).InterpretationWe found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial.</div