Enoxaparin versus Placebo to Prevent Symptomatic Venous Thromboembolism in Hospitalized Older Adult Medical Patients.

BACKGROUND: Admission to the hospital is a major risk factor for the development of venous thromboembolism (VTE). Whether thromboprophylaxis with low-molecular-weight heparin prevents symptomatic VTE in medically ill, hospitalized older adults remains debated. METHODS: In a prospective, randomized, placebo-controlled, double-blind, multicenter trial, older adults (>70 years of age) hospitalized for acute medical conditions were randomly assigned to receive 40 mg a day of low-molecular-weight heparin (enoxaparin) or placebo for 6 to 14 days. The primary efficacy outcome was the cumulative incidence of symptomatic VTE (distal or proximal deep vein thrombosis, fatal or nonfatal pulmonary embolism) at 30 days. The primary safety outcome was major bleeding. Secondary outcomes included efficacy and safety outcomes at 90 days. RESULTS: The trial was prematurely discontinued in September 2020, 5 years after enrollment began, because of drug supply issues. By the time of trial discontinuation, 2559 patients had been randomly assigned at 47 centers. Median age was 82 years and 60% of patients were female. In the intention-to-treat population, the primary efficacy outcome occurred in 22 out of 1278 (cumulative incidence, 1.8%) patients in the enoxaparin group and in 27 out of 1263 (cumulative incidence, 2.2%) patients in the placebo group (cumulative incidence difference, −0.4 percentage points; 95% confidence interval, −1.5 to 0.7), with no significant difference in time to VTE (P=0.46). The incidence of major bleeding was 0.9% in the enoxaparin group and 1.0% in the placebo group. At 90 days there were 14 symptomatic pulmonary emboli in the enoxaparin group and 25 in the placebo group; all 39 pulmonary embolism events resulted in hospital readmission and/or death, with 5 deaths from pulmonary embolism in the enoxaparin group and 11 deaths in the placebo group. CONCLUSIONS: This trial of thromboprophylaxis in medically ill, hospitalized older adults did not demonstrate that enoxaparin reduced the risk of symptomatic VTE after 1 month. Because the trial was prematurely discontinued, larger trials are needed to definitively address this question. (Funded by the French Ministry of Health Programme Hospitalier de Recherche Clinique, grant number PHRC-N-13-0283; ClinicalTrials.gov number, NCT02379806.)

Factors associated with serious vehicular accidents: A cross-sectional study in hospital emergency rooms.

AIMS: Pictograms on medicine boxes warn of potential drug-related driving hazard; we studied their association with serious accidents. METHODS: Prospective study in emergency departments of the hospitals in Bordeaux and Périgueux (France), of drivers with serious (admitted at least 24 hours) or nonserious vehicular accidents. Minors, passengers, pedestrians or subjects incapable of answering an interview were excluded. Interviews ascertained driver and accident characteristics, use of drugs with or without pictograms, use of alcohol and abuse substances, sleepiness, distractions, and mind wandering at the time of the accident, RESULTS: Between 18 October 2016 and 26 December 2018, 1200 of the 6212 drivers admitted to the hospital emergency rooms, 741 nonserious, 459 serious, were interviewed. Serious accidents were associated with male sex (odds ratio 1.89, 95% confidence interval [1.36-2.64]), age above 60 years (3.64 [2.21-6.00]), driving on local roads (3.34 [2.34-4.76]), driving a motorcycle (3.39 [2.29-5.00]), having drunk alcohol within 6 hours (2.89 [1.85-4.51]) and using a drug with a pictogram during the 24 hours previous to the accident (1.57 [1.06-2.32]). From 207 police reports, 101 drivers were not responsible, and 106 were responsible, associated with age below 40 years, driving in overcast or rainy weather (2.62 [1.29-5.33]), on local roads (3.89 [1.90-7.95]), and use of at least 1 pictogram drug in the previous week (3.12 [1.31-7.41]). CONCLUSION: The known risks of alcohol and pictogram drugs, of riding motorcycles and using local roads were confirmed. As measured, behavioural sleepiness did not predict accidents.

Effect of perioperative oxygen supplementation on 30-day surgical site infection rate in abdominal, gynecologic, and breast surgery: the ISO2 randomized controlled trial.

BACKGROUND: Benefits and limitations of supplementation with 80% fraction of inspired oxygen for preventing surgical site infections have not yet been clearly defined. Some studies have reported benefits in colorectal surgery, whereas trials in abdominal and gynecologic surgery have reported either no effect or a deleterious effect. METHODS: Controlled, randomized, assessor-blind multicenter trial, the ISO2 study, comparing the effects of hyperoxygenation (fraction of inspired oxygen, 80%) with those of 30% oxygen on the frequency of surgical site infections in routine abdominal, gynecologic, and breast surgery on 434 patients. Patients not seen in consultation after discharge were contacted. RESULTS: In total, 208 patients received 30% perioperative oxygen and 226 received 80%. There was no difference between the two groups for baseline, intraoperative, and postoperative characteristics, except for oxygen saturation at closure, higher in the 80% group (P=0.01). The frequency of 30-day surgical site infections was 7.2% (15/208) in the 30% group and 6.6% (15/226) in the 80% group (relative risk, 0.92; 95% CI [0.46-1.84], P=0.81). Frequency of adverse events (nausea and vomiting, sternal pain, cough, hypotension) was similar in the two groups. Desaturation and bradycardia were more frequent in the 30% group. In an updated meta-analysis including the result of this trial and those of eight published randomized trials, the overall relative risk was 0.97; 95% CI (0.68-1.40), I2 (inconsistency degree)=73%, (P=0.88). CONCLUSIONS: The routine use of hyperoxygenation throughout abdominal, gynecologic, and breast surgery had no effect on the frequency of 30-day surgical site infections and was not accompanied by more frequent adverse effects.

[Cancer incidence and survival among adolescents and young adults in France (1978-1997)]. / Incidence et survie des cancers de l'adolescent et de l'adulte jeune en France (1978-1997).

Malignancies are rare young French adults but represent the third significant cause of death in the cohort of 15-24 years of age. The aim of this study was to investigate incidence and survival rates of French adolescents and young adults with cancer. All cases of cancer occuring over a 20-year period (1978-1997) in the cohort of patients aged 15 to 24, were obtained from nine population-based registries (10 % of the French population). Basal cell carcinomas of the skin were excluded. 1161 and 1884 cases were recorded in adolescents and young adults, respectively. Overall incidence rates (IR) were 161.4/10(6) in adolescents aged 15-19 years (M/F ratio = 1.3), and 252.6/10(6) in young adults aged 20-24 years (M/F ratio : 1.2). During the 1978-97 period, the IRs appeared stable over the years, +0.4 % [CI95 % = -2.3 ; +3.1] (p = 0.79) for adolescents and +1.7 % [CI95 % = -4.0 ; +7.3] (p = 0.57) for young adults. Five-year overall survival rates were 69.1 % [CI95 % = 66.4-71.8] for adolescents and 74.5 % [CI95 % = 72.3-76.7] for young adults. The 5-year survival rate for patients 15-24 years improved from 62.0 % (CI95 % = 57.5-66.5) in 1978-82 to 80.2 % (IC95 % = 77.7-82.8) in 1993-97. Noteworthy, results in adolescents and young adults are poor compared to the ones from their younger counterparts, especially in patients with acute lymphoblastic leukemia, non-Hodgkin lymphoma, Ewing's sarcoma, osteosarcoma, rhabdomyosarcoma, and astrocytoma. Further studies are warranted to elucidate whether these differences are due to intrinsic biological properties of the tumor or to differences in clinical practices in the two populations.