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

Comparative Study of Salivary pH, Buffer Capacity, and Flow in Patients with and without Gastroesophageal Reflux Disease

The oral cavity has specific and individualized characteristics, with pH, saliva flow, buffer capacity, temperature, and microorganisms content influencing oral health. Currently, the prevalence of gastroesophageal reflux disease (GERD) is constantly increasing. The objective of this study was to evaluate and compare the saliva quantity at 5 min, salivary pH, and salivary buffer capacity in patients with and without GERD, necessary for establishing the correct dental treatment plan. A Saliva-Check Buffer (GC) kit was used for the determination of salivary variables. The total number of 80 patients included in the study were divided into a study group and a control group, each containing 40 patients. Saliva quantity at 5 min was lower in patients suffering from GERD. The salivary pH of these patients turned to acid values compared to the salivary pH of controls, where the values were within the normal range. In patients with GERD, the determined salivary buffer capacity was low or very low. The use of the Saliva-Check Buffer (GC) kit is a simple, easy, non-invasive and patient-accepted method, which can also be used in the dentist’s office to assess the saliva buffer capacity and pH, variables that are important for establishing a correct dental treatment plan

Factors Associated with Recurrent Ulcers in Patients with Gastric Surgery after More Than 15 Years: A Cross-Sectional Single-Center Study

Aim. We aimed to establish the independent predictive factors (from Helicobacter pylori infection, biliary reflux, histologic features of the gastric mucosa, drugs, comorbidities, and social habits) for gastric stump ulcer occurrence more than 15 years after surgery. Methods. 76 patients with previous gastric surgery were included: 21 patients with gastric ulcer (marginal ulcer or ulcer of the rest of the gastric remnant—study group) and 55 controls (nonulcer group). Results. Helicobacter pylori infection tended to be higher in the control group than in the ulcer group (14.5% vs. 4.8%, p=0.43), without statistical significance. Alcohol consumption had a significant positive association with ulcer (p=0.008), while smoking (p=0.064), low-dose aspirin (p=0.063), and biliary reflux (p=0.106) had a tendency toward statistical signification for positive association. On univariate analysis, smoking (p=0.048, OR = 3.15, 95% CI: 1.01–9.93) and low-dose aspirin consumption (p=0.067, OR = 2.63, 95% CI: 0.95–7.68) were significantly associated with ulcer. According to the multivariable regression model, alcohol consumption (OR = 6.68, 95% CI: 1.29–41.14) and biliary reflux (OR = 6.12, 95% CI: 1.36–38.26) remained significantly associated with increased odds of stump ulcer. Conclusion. Biliary reflux and alcohol consumption, but not Helicobacter pylori infection or gastrotoxic drug, seem to be the most important predictors for ulcer recurrence in patients with gastric surgery for peptic ulcer after more than 15 years

AGT A-20C (rs5050) gene polymorphism and ulcer occurrence in patients treated with low-dose aspirin: a case-control study / Polimorfismul AGT A-20C și ulcerele gastro-duodenale la pacienții sub tratament cu aspirină în doze antiagregante: studiu caz-control

Factorii genetici pot juca un rol important in evaluarea riscului efectelor secundare gastrointestinale ale aspirinei, unul din cele mai folosite medicamente în intreaga lume. Obiectivul studiului a fost identificarea unei posibile corelații între polimorfismul genic al AGT A-20C (rs5050) și ulcerele gastro-duodenale la pacienții tratați cu aspirină în doze antiagregant

Experimental Study Regarding the Behavior at Different pH of Two Types of Co-Cr Alloys Used for Prosthetic Restorations

Cobalt-chromium (Co-Cr) alloys are widely utilized in dentistry. The salivary pH is a significant factor, which affects the characteristics and the behavior of dental alloys through corrosion. This study aimed to evaluate the corrosion behavior in artificial saliva with different pH values (3, 5.7, and 7.6) of two commercial Co-Cr dental alloys manufactured by casting and by milling. Corrosion resistance was determined by the polarization resistance technique, and the tests were carried out at 37 ± 1 °C, in Carter Brugirard artificial saliva. After the electrochemical parameters, it can be stated that the cast Co-Cr alloy has the lowest corrosion current density, the highest polarization resistance, and the lowest speed of corrosion in artificial saliva with pH = 7.6. In the case of milled Co-Cr alloy, the same behavior was observed, but in artificial saliva with pH = 5.7, it recorded the most electropositive values of open circuit potential and corrosion potential. Although both cast and milled Co-Cr alloys presented a poorer corrosion resistance in artificial saliva with a more acidic pH value, the milled Co-Cr alloy had better corrosion behavior, making this alloy a better option for the prosthetic treatment of patients suffering from GERD

Evaluation of the Behavior of Two CAD/CAM Fiber-Reinforced Composite Dental Materials by Immersion Tests

Fiber-reinforced composites are used as restorative materials for prosthetic oral rehabilitation. Gastroesophageal reflux disease (GERD) is an accustomed affection with various oral manifestations. This study aimed to evaluate the behavior of two high-performance CAD/CAM milled reinforced composites (Trinia™, TriLor) in artificial saliva at different pH levels through immersion tests, and to determine if changes in mass or surface morphology at variable pH, specific for patients affected by GERD, appear. After investigating the elemental composition and surface morphology, the specimens were immersed in Carter Brugirard artificial saliva for 21 days at different pH values (5.7, 7.6, and varying the pH from 5.7 to 3). The values of the weighed masses during the immersion tests were statistically processed in terms of mean and standard deviation. Results suggested that irrespective of the medium pH, the two composites presented a similar mass variation in the range of −0.18 (±0.01)–1.82 (±0.02) mg after immersion, suggesting their stability when in contact with artificial saliva, an aspect which was also highlighted by scanning electron microscope (SEM) analysis performed on the immersed surfaces. Novel composite biomaterials can be a proper alternative for metal alloys used for prosthetic frameworks in patients suffering from GERD

Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: Observations and Dilemmas after 10 Years of Real-Life Experience

Advanced Parkinson’s disease (APD) cannot be treated efficiently using the classical medications however, in recent decades invasive therapeutical methods were implemented and confirmed as effective. One of these methods makes it possible to continue the levodopa (LD) supplementation as a gel administered directly into the upper intestine. However, there are a number of unanswered questions regarding this method. Therefore, we retrospectively analyzed a 10-year period of selected patients that were treated with levodopa/carbidopa intestinal gel (LCIG). We included all APD patients with motor fluctuations and dyskinesia at presentation. LCIG treatment was started in 150 patients: on average these patients received LD for 10.6 ± 4.4 years with a frequency of 5.2 ± 1.0/day until the introduction of LCIG. The estimated and the real LCIG dose differed significantly (mean: 1309 ± 321 mg vs. 1877 ± 769 mg). The mean duration of LCIG administration was 19.8 ± 3.6 h, but in a number of 62 patients we had to administer it for 24 h, to maximize the therapeutic benefit. A carefully and individually adjusted LCIG treatment improves the quality of life of APD patients, but questions remain unresolved even after treating a large number of patients. It is important to share the ideas and observations based on the real-life experience related to the optimal timing, the appropriate dose and duration of administration of the LCIG

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