Background The use of prothrombin complex concentrates and the role of plasma concentration of anticoagulants in the management of bleeding in patients treated with direct oral anticoagulants are still debated. Our aim was to describe management strategies and outcomes of severe bleeding events in patients treated with direct oral anticoagulants. Methods We performed a prospective cohort study of 732 patients treated with dabigatran, rivaroxaban, or apixaban hospitalized for severe bleeding, included prospectively in the registry from June 2013 to November 2015. Results Bleeding was gastrointestinal or intracranial in 37% (212 of 732) and 24% (141 of 732) of the cases, respectively. Creatinine clearance was lower than 60 ml/min in 61% (449 of 732) of the cases. The plasma concentration of direct oral anticoagulants was determined in 62% (452 of 732) of the cases and was lower than 50 ng/ml or higher than 400 ng/ml in 9.2% (41 of 452) and in 6.6% (30 of 452) of the cases, respectively. Activated or nonactivated prothrombin complex concentrates were administered in 38% of the cases (281 of 732). Mortality by day 30 was 14% (95% CI, 11 to 16). Conclusions Management of severe bleeding in patients treated with direct oral anticoagulants appears to be complex. The use of prothrombin complex concentrates differs depending on bleeding sites and direct oral anticoagulant plasma concentrations. Mortality differs according to bleeding sites and was similar to previous estimates.
Background: The aim of the study was to describe the clinical and endoscopic characteristics and management of severe acute gastrointestinal (GI) bleeding in patients treated with direct oral anticoagulants (DOACs). Methods: Patients hospitalized for severe GI bleeding under DOAC therapy were identified in 36 centres between June 2013 and March 2016. Clinical outcomes including re-bleeding, major cerebral and cardiovascular events or all-cause mortality were assessed initially and 30 days after admission. Results: A total of 59 patients with anonymized detailed endoscopy reports for severe GI bleeding were considered. Mean age was 79.3 ± 10.0 years and 61.3% of patients were men. Patients had histories of hypertension (65.6%), heart failure (29.5%), coronary artery disease (27.9%), stroke (19.7%) and peripheral vascular disease (36.1%). Life-threatening bleeding was observed in 42.6%. Mean number of packed red blood cells transfused was 3.4 (range 1–31). Aetiology of bleeding (identified in 66.2% of cases) was peptic gastroduodenal ulcers (22%), diverticula (11.9%), angiodysplasia (8.5%), colorectal neoplasia (5.1%) and anorectal causes (5.1%). Endoscopic haemostasis was performed in 37.7% of patients. A low haemoglobin level was predictive of life-threatening bleeding and death in multivariate analysis. All-cause mortality rate at day 30 was 11.8%. Conclusions: In this cohort of elderly patients with multiple comorbidities treated with DOACs, the main cause of severe acute GI bleeding was peptic gastroduodenal ulcer and mortality was high.
Background Quality care during childbirth requires that health care providers have not only excellent skills but also appropriate and considerate attitudes and behavior. Few studies have examined the proportion of women in Western countries expressing dissatisfaction with such inappropriate or inconsiderate behavior. This study evaluated this proportion in a sample presumably representative of French maternity units. Methods This prospective multicenter study, using data from a selfadministered questionnaire, took place in 25 French maternity units during one week in September 2018. The primary outcome measure was mothers' self‐reported dissatisfaction with blatantly inappropriate behavior (ie, inappropriate attitude, inadequate respect for privacy, insufficient gentleness of care, and/or inappropriate language) by health care workers in the delivery room. The secondary outcome was their self‐reported dissatisfaction with these workers' inconsiderate behavior (ie, unclear and inappropriate information, insufficient participation in decision‐making, or deficient consideration of pain). Results Of 803 potentially eligible women, 627 completed the questionnaire after childbirth; 5.62% (35/623, 95% CI: 3.94‐7.73) reported dissatisfaction with blatantly inappropriate behaviors and 9.79% (61/623, 95% CI: 7.57‐12.40) with inconsiderate behaviors. The main causes of dissatisfaction reported by women in this survey were the inadequate consideration of their pain and the failure to share decision‐making. Conclusions Most of the women were satisfied with how health care workers behaved towards them in the delivery room. Nonetheless, health care staff must be aware of women's demands for greater consideration of their expressions of pain and of their voice in decisions.
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