Management of epistaxis associated with oral antithrombotic drugs in emergency department and impact on prescription thereafter.

OBJECTIVES: To describe management, and to assess factors associated with antithrombotic prescription thereafter in patients who had epistaxis referred to emergency department (ED). DESIGN: Prospective cohort study. From EDs, clinical, biological and hospital data were collected. The clinical database was linked to the French Health Insurance Database where we retrieved antithrombotic drug deliveries in a 3-month period before and after referral. SETTING: Multicentric population-based cohort study within five well-defined areas. PARTICIPANTS: We considered 306 patients referred for epistaxis with a stable oral antithrombotic regimen before referral. MAIN OUTCOME MEASURES: We considered management, hospital outcome and case fatality. Antithrombotic prescription in a 3-month follow-up period was categorised into three classes: no change, class change, or discontinuation. During follow-up, hospitalisation for epistaxis or ischaemic events was searched. RESULTS: Among 306 adult individuals (mean age: 76 years), 166 took oral anticoagulant and 140 an antiplatelet drug. Blood transfusion was needed in 13.7% of patients and anterior packing alone in 61%. Half of the patients were hospitalised; 301 were discharged alive. Considering antithrombotic prescription thereafter we observed no change in 219 patients (72.8%), class changes in 47 patients (15.6%) and discontinuation in 35 patients (11.6%). We identified four independent predictors for antithrombotic prescription: hospitalisation (vs. returning home, p = .05), age (p = .03), haemoglobin level (p = .03) and oral anticoagulant (vs. antiplatelet agent, p < .001). During the 3 months following discharge, 2 thrombotic and 15 bleeding events were identified. CONCLUSIONS: Epistaxis referred to emergency department had an impact on subsequent antithrombotic prescription. CLINICAL TRIAL REGISTRATION: Clinical Trials.gov identifier: NCT02886533.

Clinical use of low-dose parenteral anticoagulation, incidence of major bleeding and mortality: a multi-centre cohort study using the French national health data system.

PURPOSE: Low-dose parenteral anticoagulation has demonstrated its efficacy for venous thromboembolism prophylaxis in randomized trials. However, current practice is not widely documented. In ambulatory settings, we aimed to provide an overview of the clinical use of low-dose parenteral anticoagulation in France and to assess the incidence of major bleeding and death rates. METHODS: A population-based prospective cohort study using the French national health data system (SNIIRAM) identified 142,815 adults living in five well-defined geographical areas who had a course of low-dose parenteral anticoagulants (a total of 150,389 courses) in the period 2013-2015. The main outcome measures were the types of low-dose parenteral anticoagulant, the duration and the clinical context. Adjusted incidence rate ratios (IRR) were derived from Poisson models. RESULTS: Enoxaparin was the most frequently prescribed anticoagulant (58.9%) followed by tinzaparin (27.3%) and fondaparinux (10.9%). Patients receiving unfractionated heparin (N = 766, 0.53%) were older, more frequently had renal disease (48.75%) and had a higher modified HAS-B(L)ED score (≥ 3 in 61.6%) than patients receiving low-molecular weight heparin (LMWH). Surgical thrombo-prophylaxis was the most frequent indication (47.6%), followed by medical prophylaxis (29.9%). Course durations were in line with regulatory agency specifications. Only 43 (0.028%) major bleeding events and 478 (0.32%) deaths were observed. Adjusted IRRs for major bleeding or death were not significantly different for dalteparin/nadroparin, tinzaparin or fondaparinux compared to enoxaparin. CONCLUSION: Very low incidence rates of major bleeding and all-cause mortality were observed. Our study confirms the safety of LMWHs and fondaparinux in thrombo-prophylaxis in ambulatory settings. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02886533.

Ground-level falls among nonagenarians: the impact of pre-injury antithrombotic therapy.

Among nonagenarians admitted to our emergency department (ED) for ground-level falls, we assessed the impact of pre-injury antithrombotic (AT) treatment on the post-traumatic consequences, and identified risk factors for 1-month mortality. All eligible patients were consecutively included over an 18-month period. Head trauma was attested by reliable medical history, witnesses or recent external signs. Patient characteristics, post-traumatic consequences and outcomes were compared across patients with and without AT. Risk factors for 1-month mortality were assessed using multivariate logistic regression analyses. 1014 consecutive nonagenarians were analysed, 675 (66.6%) with AT and 339 (33.4%) without. Head trauma (n = 429, 42.3%) was significantly more frequent among patients with AT (49.2 vs 28.6%, p < 0.001). Intracranial hemorrhage (ICH, n = 43, 4.2%), mostly subdural hematomas (58%), were more frequently found among patients with AT (p < 0.015). At least one fracture was diagnosed for 23.9% of the population, mostly hip fractures, without any significant association with AT. At 1 month, 103 patients (10.2%) had died. The independent risk factors for 1-month mortality were: ICH associated with head trauma (OR = 5.9, 95% CI 2.5-14), Glasgow coma score ≤ 12 at admission (OR = 10; 95% CI 2.2-46), atrial fibrillation (OR = 2.2, 95% CI 1.4-3.4) and age ≥ 95 years (OR = 1.6, 95% CI 1.0-2.5). Our results support accurate and regular assessment of the benefit/risk ratio for antithrombotic treatment among elderly people at high risk for falls.

Acute, major muscular hematoma associated with antithrombotic agents: A multicenter real-world cohort.

BACKGROUND: There is little data on major muscular hematomas and the little there is has mainly focused on patients exposed to oral anticoagulants. OBJECTIVE: To describe the clinical characteristics, management and outcomes of patients admitted to emergency department (ED) for major muscular hematoma associated with an antithrombotic agent, and to identify predictors of in-hospital mortality. PATIENTS AND METHODS: Over a three-year period, all consecutive cases of adult patients admitted to the ED of 5 tertiary care hospitals for major muscular hematoma while exposed to an antithrombotic agent were prospectively collected and medically validated. Clinical and biological data, therapeutic management of the bleeding event, and in-hospital mortality were collected from the medical records and compared across five groups of hematoma locations. Potential confounders were taken in account using a multivariate binomial regression model. RESULTS: Three hundred and seventy-five patients were included (mean age = 81.4 years): 271 were exposed to vitamin K antagonists, 58 to parenteral anticoagulants (heparin, LMWH, fondaparinux), 33 to antiplatelets, and 13 to direct oral anticoagulants. The muscular hematomas were located in the lower limbs (n = 198), the rectus sheath (n = 71), the iliopsoas (n = 45), the upper limbs (n = 33), or elsewhere (n = 28). Reversal therapy was prescribed for 48.5% of patients, red cell transfusions for 63.6%, surgery for 12.3% and embolization for 3.5%. For 84% of patients, hospitalization was required, with a median length of stay of 10 days. Overall, in-hospital mortality was 8.5%. Reversal therapy, the need for intensive care and mortality were significantly more frequent among patients with iliopsoas hematomas. The independent predictors of in-hospital mortality were: decrease in mean arterial pressure (RR = 1.84), decrease in hemoglobin level (RR = 1.37) and the iliopsoas location (RR = 3.06). CONCLUSION: Frail elderly patients with major muscular hematomas linked to antithrombotic agents risk substantial morbidity and in-hospital mortality. The iliopsoas location was the most life-threatening bleeding site. Close observation of this population is warranted to ensure better outcomes.

Major gastrointestinal bleeding and antithrombotics: Characteristics and management.

BACKGROUND: There are few reports on major gastrointestinal (GI) bleeding among patients receiving an antithrombotic. AIM: To describe clinical characteristics, bleeding locations, management and in-hospital mortality related to these events. METHODS: Over a three-year period, we prospectively identified 1080 consecutive adult patients admitted in two tertiary care hospitals between January 1, 2013 and December 31, 2015 for major GI bleeding while receiving an antithrombotic. The bleeding events were medically validated. Clinical characteristics, causative lesions, management and fatalities were described. The distribution of antithrombotics prescribed was compared across the bleeding lesions identified. RESULTS: Of 576 patients had symptoms of upper GI bleeding and 504 symptoms of lower GI bleeding. No cause was identified for 383 (35.5%) patients. Gastro-duodenal ulcer was the first causative lesion in the upper tract (209 out of 408) and colonic diverticulum the first causative lesion in the lower tract (120 out of 289). There was a larger proportion of direct oral anticoagulant use among patients with lower GI than among those with upper GI lesion locations (P = 0.03). There was an independent association between gastro-duodenal ulcer and antithrombotic use (P = 0.03), taking account of confounders and proton pump inhibitor co-prescription. Pair wise comparisons pointed to a difference between vitamin K antagonist, direct oral anticoagulants, and antiplatelet agents in monotherapy vs dual antiplatelet agents. CONCLUSION: We showed a higher rate of bleeding lesion identification and suggested a different pattern of antithrombotic exposure between upper and lower GI lesion locations and between gastro-duodenal ulcer and other identified upper GI causes of bleeding. Management was similar across antithrombotics and in-hospital mortality was low (5.95%).

Analgesic consumption evolution at the emergency department of a university hospital (2006-2017): a defined daily doses based analysis.

OBJECTIVE: Pain management in the emergency department (ED) is a key issue that must be regularly evaluated. Practice evaluation gold standard remains patient file analysis, but is highly time consuming. The aim of this study is to evaluate the interest of a defined daily dose (DDD) based analysis in the evaluation of pain management in the ED. METHODS: A local indicator was elaborated based on the DDD concept: the defined dose per admission (DDA). Unlike the DDD that corresponds to a standardised total dose administered over a day, the DDA represents the average total dose administrated to a patient throughout the stay in the ED. A DDA was assigned to every analgesic, from step 1 to step 3. Oral and injectable forms were studied, but transdermal forms were not considered. DDA values were assimilated to the existing DDDs when these were officially established by the WHO. When values were not defined by the WHO, mean values observed in local practice were selected. Annual numbers of patients admitted to the ED and quantities of each analgesic supplied by the pharmacy ward were annually extracted from respective data files. Paediatric patients being treated at a specific separate ED, only adults were considered throughout the study. Raw quantities of analgesics used each year were converted to their equivalent amounts in DDA, and then expressed in numbers of DDA per 100 admissions (DDA/100A). This indicator allowed us to describe relative evolutions of analgesics prescriptions from 2006 to 2017. RESULTS: Analgesic overall use rose from 18.4 to 30.2 DDA/100A between 2006 and 2017, representing a prescription increase of 64%. Throughout the study, step 1 analgesics rose from 10.8 to 19.3 DDA/100A (+79%), step 3 from 1.8 to 5.4 (+200%) and step 2 remained stable around 5.6 DDA/100A. The integration of orodispersible paracetamol tablets in 2013 allowed us to halve the consumption of injectable paracetamol in the long term and had no effect on classic paracetamol oral forms such as tablets or capsules. Tramadol increased from 41% to 78% among step 2 analgesics after the withdrawal of dextropropoxyphene in 2011. Codeine use shows a steady decline from 1.9 DDA/100A in 2011 to 0.72 in 2017. DISCUSSION/CONCLUSION: The DDA concept appears to be an effective tool for assessing long-term analgesic-use trends at hospital EDs. This tool can also mitigate one major bias at EDs, that is the lack of traceability of analgesic administration in emergency contexts. This tool could be adjusted by integrating the average length of stay in the ED.

Major bleeding risk and mortality associated with antiplatelet drugs in real-world clinical practice. A prospective cohort study.

BACKGROUND: Major bleedings other than gastrointestinal (GI) and intracranial (ICH) and mortality rates associated with antiplatelet drugs in real-world clinical practice are unknown. The objective was to estimate major bleeding risk and mortality among new users of antiplatelet drugs in real-world clinical practice. METHODS AND FINDINGS: A population-based prospective cohort using the French national health data system (SNIIRAM), identified 69,911 adults living within five well-defined geographical areas, who were new users of antiplatelet drugs in 2013-2015 and who had not received any antithrombotics in 2012. Among them, 63,600 started a monotherapy and 6,311 a dual regimen. Clinical data for all adults referred for bleeding was collected from all emergency departments within these areas, and medically validated. Databases were linked using common key variables. The main outcome measure was time to major bleeding (GI, ICH and other bleedings). Secondary outcomes were death, and event-free survival (EFS). Hazard ratios (HR) were derived from adjusted Cox proportional hazard models. We used Inverse Propensity of Treatment Weighting as a stratified sensitivity analysis according to the antiplatelet monotherapy indication: primary prevention without cardiovascular (CV) risk factors, with CV risk factors, and secondary prevention. We observed 250 (0.36%) major haemorrhages, 81 ICH, 106 GI and 63 other types of bleeding. Incidences were twice as high in dual therapy as in monotherapy. Compared to low-dose aspirin (≤ 100 mg daily), high-dose (> 100 up to 325 mg daily) was associated with an increased risk of ICH (HR = 1.80, 95%CI 1.10 to 2.95). EFS was improved by high-dose compared to low-dose aspirin (1.41, 1.04 to 1.90 and 1.32, 1.03 to 1.68) and clopidogrel (1.30, 0.73 to 2.3 and 1.7, 1.24 to 2.34) respectively in primary prevention with and without CV risk factors. CONCLUSION: The incidence of major bleeding and mortality was low. In monotherapy, low-dose aspirin was the safest therapeutic option whatever the indication. TRIAL REGISTRATION: NCT02886533.

Major bleeding risk associated with oral anticoagulant in real clinical practice. A multicentre 3-year period population-based prospective cohort study.

AIMS: The objective was to compare major bleeding risk of direct oral anticoagulants (DOACs; per type and dose) with vitamin K antagonists (VKAs), irrespective of indication, using real-world data. METHODS: A population-based prospective cohort study, using the French national health data system (SNIIRAM), identified 47 469 adults living within 5 well-defined geographical areas, who were new users of oral anticoagulants in the period 2013-2015: 20 205 VKA users, 19 579 rivaroxaban users, 4225 dabigatran users and 3460 apixaban users. From all emergency departments within these areas, clinical data for all adults referred for bleeding was collected and medically validated. The databases were linked for common key variables. The main outcome measure was major bleeding: intracranial haemorrhage, major gastrointestinal bleeding and other major bleeding events. Hazard ratios were derived from adjusted Cox proportional hazard models. We used propensity score weighting as a sensitivity analysis, with separate analyses according to indications (atrial fibrillation or venous thromboembolism). RESULTS: Compared to VKAs, high and low-dose DOACs were associated with a reduced risk of intracranial haemorrhage (adjusted hazard ratio 0.55, 95% confidence interval 0.37-0.82 and 0.54, 0.26-1.12 respectively), and a reduced risk of other major bleeding events (0.41, 0.29-0.58 and 0.41, 0.22-0.79 respectively), irrespective of duration and indication. Neither DOAC dose evidenced any significant difference from VKAs in terms of risk of major gastrointestinal bleeding. CONCLUSION: There is a clear benefit of using DOACs with regard to intracranial haemorrhage. The study provides new insight into major gastrointestinal and other major bleeding events.

Sensitivity and specificity of an algorithm based on medico-administrative data to identify hospitalized patients with major bleeding presenting to an emergency department.

BACKGROUND: Validation studies on an ICD-10-based algorithm to identify major bleeding events are scarce, and mostly focused on positive predictive values. OBJECTIVE: To evaluate the sensitivity and specificity of an ICD-10-based algorithm in adult patients referred to hospital. METHODS: This was a cross-sectional, retrospective analysis. Among all hospital stays of adult patients referred to Rennes University Hospital, France, through the emergency ward in 2014, we identified major bleeding events according to an index test based on a list of ICD-10 diagnoses. As a reference, a two-step process was applied: firstly, a computerized request for electronic health records from the emergency ward, using several hemorrhage-related diagnostic codes and specific emergency therapies so as to discard stays with a very low probability of bleeding; secondly, a chart review of selected records was conducted by a medical expert blinded to the index test results and each hospital stay was classified into one of two exclusive categories: major bleeding or no major bleeding, according to pre-specified criteria. RESULTS: Out of 16,012 hospital stays, the reference identified 736 major bleeding events and left 15,276 stays considered as without the target condition. The index test identified 637 bleeding events: 293 intracranial hemorrhages, 197 gastrointestinal hemorrhages and 147 other bleeding events. Overall, sensitivity was 65% (95%CI, 62 to 69), and specificity was 99.0%. We observed differential sensitivity and specificity across bleeding types, with the highest values for intracranial hemorrhage. Positive predictive values ranged from 59% for "other" bleeding events, to 71% (95%CI, 65 to 78) for gastrointestinal hemorrhage, and 96% for intracranial hemorrhage. CONCLUSIONS: Low sensitivity and differential measures of accuracy across bleeding types support the need for specific data collection and medical validation rather than using an ICD-10-based algorithm for assessing the incidence of major bleeding.

Guideline-Based Clinical Assessment Versus Procalcitonin-Guided Antibiotic Use in Pneumonia: A Pragmatic Randomized Trial.

STUDY OBJECTIVE: Efforts to reduce unnecessary and unnecessarily long antibiotic treatment for community-acquired pneumonia have been attempted through use of procalcitonin and through guidelines based on serial clinical assessment. Our aim is to compare guideline-based clinical assessment- and procalcitonin algorithm-guided antibiotic use among patients with community-acquired pneumonia. METHODS: We performed a pragmatic, randomized, multicenter trial from November 2012 to April 2015 at 12 French hospitals. We included emergency department (ED) patients older than 18 years with community-acquired pneumonia. Patients were randomly assigned to either the procalcitonin-guided or clinical assessment group. In accordance with past studies, we hypothesized that serial clinical assessment would be superior to procalcitonin-guided care. The primary outcome was antibiotic duration, and secondary outcomes included rates of antibiotic duration less than or equal to 5 days, and clinical success and combined serious adverse outcomes at 30 days in the intention-to-treat population. RESULTS: Of 370 eligible patients, 285 (77%) were randomly assigned to either clinical assessment- (n=143) or procalcitonin-guided care (n=142). Median age was 67 years (range 18 to 93 years) and 40% of patients were deemed to have Pneumonia Severity Index class IV or V. Procalcitonin algorithm adherence was 76%. Antibiotic duration was not significantly different between clinical assessment- and procalcitonin-guided groups (median 9 versus 10 days, respectively). Clinical success rate was 92% in each group and serious adverse outcome rates were similar (15% versus 20%, respectively). CONCLUSION: Guideline-based serial clinical assessment did not reduce antibiotic exposure compared with procalcitonin-guided care among ED patients with community-acquired pneumonia. The strategies were similar in terms of duration of antibiotic use and clinical outcomes.

Major bleeding with antithrombotic agents: a 2012-2015 study using the French nationwide Health Insurance database linked to emergency department records within five areas - rationale and design of SACHA study.

Bleeding represents the most recognized and feared complications of antithrombotic drugs including oral anticoagulants. Previous studies showed inconsistent results on the safety profile. Among explanations, bleeding definition could vary and classification bias exists related to the lack of medical evaluation. To quantify the risk of major haemorrhagic event and event-free survival associated with antithrombotic drugs (vitamin K antagonist [VKA], non-VKA anticoagulant [NOAC], antiplatelet agent, parenteral anticoagulant) in 2012-2015, we linked the French nationwide Health Insurance database (SNIIRAM) with a local 'emergency database' (clinical and biological data collected in clinical records). In the VKA-NOAC comparison, a Cox regression analysis will be used to estimate the hazard ratio of major haemorrhagic event adjusted on gender, modified HAS-BLED score and comorbidities. A distinction on the type of major haemorrhagic event (intracranial, gastrointestinal and other haemorrhagic events) was made. We present here the study protocol and the database linkage results. Using six linkage keys, among 3 837 557 hospital visits identified in SNIIRAM, 5264 have been matched with a major haemorrhagic event identified in the 'emergency database', thus clinically confirmed. The 1090 unmatched haemorrhagic events could be explained by the fact that patients were not extracted in the SNIIRAM database (patients living in accommodation establishment with internal use of pharmacy, military people with specific insurance…). We showed the value of SNIIRAM enrichment with a clinical database, a necessary step to categorize haemorrhagic events by a clinically relevant definition and medical validation; it will allow to estimate more accuracy each type of haemorrhagic event.

Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study.

BACKGROUND: The ability of the pulmonary embolism rule-out criteria (PERC) to exclude pulmonary embolism without further testing remains debated outside the USA, especially in the population with suspected pulmonary embolism who have a high prevalence of the condition. Our main objective was to prospectively assess the predictive value of negative PERC to rule out pulmonary embolism among European patients with low implicit clinical probability. METHODS: We did a multicentre, prospective, observational study in 12 emergency departments in France and Belgium. We included consecutive patients aged 18 years or older with suspected pulmonary embolism. Patients were excluded if they had already been hospitalised for more than 2 days, had curative anticoagulant therapy in progress for more than 48 h, or had a diagnosis of thromboembolic disease documented before admission to emergency department. Physicians completed a standardised case report form comprising implicit clinical probability assessment (low, moderate, or high) and a list of risk factors including criteria of the PERC rule. They were asked to follow international recommendations for diagnostic strategy, masked to PERC assessment. The primary endpoint was the proportion of patients with low implicit clinical probability and negative PERC who had venous thromboembolic events, diagnosed during initial diagnostic work-up or during 3-month follow-up, as externally adjudicated by an independent committee masked to the PERC and clinical probability assessment. The upper limit of the 95% CI around the 3-month thromboembolic risk was set at 3%. We did all analyses by intention to treat, including all patients with complete follow-up. This trial is registered with ClinicalTrials.gov, number NCT02360540. FINDINGS: Between May 1, 2015, and April 30, 2016, 1773 consecutive patients with suspected pulmonary embolism were prospectively assessed for inclusion, of whom 1757 were included. 1052 (60%) patients were classed as having low clinical probability, 49 (4·7%, 95% CI 3·5-6·1) of whom had a venous thromboembolic event. In patients with a low implicit clinical probability, 337 (32%) patients had negative PERC, of whom four (1·2%; 95% CI 0·4-2·9) went on to have a pulmonary embolism. INTERPRETATION: In European patients with low implicit clinical probability, PERC can exclude pulmonary embolism with a low percentage of false-negative results. The results of our prospective, observational study allow and justify an implementation study of the PERC rule in Europe. FUNDING: French Ministry of Health.

Safety of Fixed Dose of Antihypertensive Drug Combinations Compared to (Single Pill) Free-Combinations: A Nested Matched Case-Control Analysis.

To compare serious adverse events of fixed-dose dual antihypertensive drug combination (FIXED) to component-based free-combination (FREE).A population-based nationwide cohort from the French Health Insurance System included subjects over 50 years with first time claims (new user) in the second half of 2009 for a calcium-channel blocker or a thiazide-like diuretic in combination with either an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker as FREE or FIXED. We designed a nested matched case-control analysis with 304 cases, hospitalized for hypotension, syncope, or collapse (n = 224), renal failure (n = 19), hyponatremia, hyper- or hypokalemia (n = 61) and 1394 controls matched for gender, age, date of inclusion in the cohort, and administrative county. Subjects with a medical history of cardiovascular disease, chronic renal failure, or cancer were excluded.The mean age ±â€ŠSD was 73 ±â€Š10 years and 70% were women. Based on the last delivery preceding the index date, 1414 patients (83%) were exposed to FIXED. Homogeneity of FIXED effect compared to FREE across components of the main composite outcome was rejected (P = 0.0099). FIXED formulation significantly increased the odd of the most frequent component (ie, hypotension, syncope, or collapse): OR = 1.88 (95% CI: 1.15-3.05) compared to FREE after adjusting for confounding factors including dose.Serious adverse event occurring in the early phase of treatment deserves attention of physicians because it could alter the benefit/risk ratio of antihypertensive drug combination.

Emergency admissions for major haemorrhage associated with direct oral anticoagulants.

INTRODUCTION: To describe the population admitted in an emergency department of a teaching hospital for severe bleeding associated with direct oral anticoagulants (DOAC). METHOD: During a three-year period (2012-2014) patients older than 16 years were prospectively identified by haemorrhagic symptoms from computerised requests. At least one of the following criteria defined major haemorrhage: haemorrhagic shock, unstable haemodynamic, need for transfusion or haemostatic procedure, or a life threatening location. RESULTS: Fifty four patients, 23 receiving dabigatran, 30 rivaroxaban and one apixaban were included, 2 in 2012, 35 in 2013 and 17 in 2014. Median age was 84 years (range 63-99) with a sex ratio of 1.16. Haemorrhagic complications were gastrointestinal (n=27), intracranial (n=12) or miscellaneous (n=15). Indication of DOAC was stroke prevention in atrial fibrillation in 49 cases and deep vein thrombosis in 5 cases. Hospitalization was required for 45 patients (83%) with a mean length of stay of 8.5 days. Sixteen patients needed intensive care. Reversal therapy was prescribed in 11 patients. At 1 month, overall mortality was 24%, reaching 41.7% for intracranial haemorrhage. Among surviving patients, DOAC was stopped in 10 cases, continued in 17 patients and switched for other antithrombotic in 17 patients. CONCLUSION: Our study contributes to the post marketing surveillance of major haemorrhagic complications associated with DOAC. It takes part to the knowledge about the course of this severe event in emergencies. Careful awareness in risk benefit assessment, especially in elderly, is needed.

Emergency admissions for major haemorrhage associated with antithrombotics: a cohort study.

INTRODUCTION: to describe antithrombotic-related major haemorrhage, therapeutic management and outcomes in patients admitted to an emergency department of a teaching hospital. MATERIAL AND METHOD: This prospective cohort included patients older than 16years with antithrombotic-related major haemorrhage identified by monthly diagnostic codes computerised requests. Major haemorrhage was defined by at least one the following criteria: unstable hemodynamic, haemorrhagic shock, uncontrollable bleeding, need for transfusion or haemostatic procedure, or a life threatening location. RESULTS: between January 1, 2011 and December 31, 2012, 913 patients met the inclusion criteria (1.2 patients per day), median age 82. Oral anticoagulants alone or in combination were used by 429 patients, antiplatelet agents (alone or dual therapy) by 420 patients, and parenteral anticoagulants by 64 patients. Major haemorrhages were: gastrointestinal bleeding (37.5%), intracranial haemorrhage (34.4%), muscular hematoma (9.4%), external haemorrhage (16.9%) and internal haemorrhage (1.9%). At 1month, 179 patients (19.8%) died, mostly patients with intracranial haemorrhage (64.2%). Prognostic factors for death were age and Glasgow coma scale at admission for intracranial haemorrhage, age and mean arterial pressure at admission for other major haemorrhages. Oral anticoagulant therapy was a predictor for death in intracranial haemorrhages. Reversal therapy was initiated in only 50.5% of patients with vitamin K antagonists, without effect on the mortality rate. CONCLUSION: This study shows the magnitude and the severity of antithrombotic-related major haemorrhage. The high mortality rate supports careful awareness in individual risk benefit assessment, especially for elderly.

Frequency and severity of adverse drug reactions due to self-medication: a cross-sectional multicentre survey in emergency departments.

BACKGROUND: Little is known about the relation of adverse drug reactions (ADRs) to self-use of medications. OBJECTIVE: The aim of this study was to determine the frequency and severity of ADRs related to self-medication (ADR-SM) among emergency department (ED) patients and to describe their main characteristics. METHODS: A prospective, cross-sectional, observational study was conducted over a period of 8 weeks (1 March to 20 April 2010), in the ED of 11 French academic hospitals. Adult patients presenting to the ED during randomization periods were included, with the exception of cases of self-drug poisoning, inability to complete self-medication questionnaire, or refusal. Clinical outcomes were assessed as well as history of self-medication behaviours and all drugs taken. All doubtful files and those related to ADR-SM were systematically reviewed by an expert committee. RESULTS: A total of 3,027 of 4,661 patients presenting to the ED met the inclusion criteria. Of these, 84.4 % declared a self-medication behaviour, 63.7 % took at least one non-prescribed drug during the previous 2 weeks and 59.9 % took a prescribed medication. A total of 296 patients experienced an ADR (9.78 %), of which 52 (1.72 %) were related to self-medication. Those ADRs related to self-medication included prescribed drugs (n = 19), non-prescribed drugs (n = 17), treatment discontinuation (n = 14), and interactions between non-prescribed and prescribed drugs (n = 2). The ADRs attributed to non-prescribed drugs represented 1 % of all patients taking non-prescribed drugs (n = 1,927). ADR severity was significantly lower for those related to self-medication (p = .032). CONCLUSION: Self-medication is frequent; its potential toxicity should not be neglected, taking into account the rate of adverse drug reactions in about 1 % of ED patient.

Managing an emergency department by analysing HIS medical data: a focus on elderly patient clinical pathways.

INTRODUCTION: The objective of this paper is to present complementary views of the activity of the emergency department for a specific group of patients. Once validated, these views will be used as decision support tools for better managing the department and providing better care delivery for this population. The views are produced from the data stored in Healthcare Information Systems that correspond potentially to a vast source of information for supporting decisions on management or public health issues. METHOD: The study focuses on two groups of patients: the elderly population (over 75-years-old) and the under 75-year-old patients, at the Rennes hospital. The validation of the views is performed by comparing results for the two distinct groups. Relevant data were extracted from the Emergency Department database. Several analysis (like cusum chart) and representation tools (Graphviz) were used to study the patients' pathways, the dynamics of arrivals and the patients' characteristics. RESULTS: The representations provided a synthetic, global and comprehensive view of the department activities, to the satisfaction of the clinicians. The study showed that ICD-10 coding, assigned at the patient's departure from the emergency department hence from all available known clinical data, is not appropriate for the elderly population as these patients are mainly diagnosed by "symptoms" and several solutions are proposed. Finally, it is stressed out that a proper delivery of care to elderly patients should require some level of scheduling in the emergency department that is by essence characterized by its non scheduled activity.

Towards a decision support system for optimising clinical pathways of elderly patients in an emergency department.

UNLABELLED: Data stored in Healthcare Information Systems correspond potentially to a vast source of information for supporting decisions in management or public health issues. The presented study illustrates clinical data valuation, through the analysis of clinical pathways of elderly patients at the Emergency Department (ED) of Rennes hospital. METHOD: Relevant data were extracted from the Emergency Department database. Several analysis (e.g., cusum method) and representation tools (e.g., Graphviz) were used to study the patients' pathways, the dynamics of flows and the patients' characteristics. RESULTS: 4951 admissions were analysed and visualized. The representations provided a synthetic, global and comprehensive view of the department activities, to the satisfaction of the clinicians. Limitations of the ICD-10 coding of the diagnoses at the ED were pointed out as well as syntax and semantic interoperability issues. A solution is proposed for automating and scaling the Decision Support System.

[Admissions of elderly to French emergency departments related to adverse drug events]. / Admissions des sujets âgés aux Services d'Accueil des Urgences pour effets indésirables médicamenteux.

AIMS: To investigate the characteristics of adverse drug events (ADE) causing emergency medical admissions in the elderly. METHODS: Data were obtained from two prospective cross sectional studies with similar experimental design which were carried out in seven French emergency departments in 1999 and 2003. The proportion of ADE leading to admission, their severity and preventability were assessed in patients aged > or =70 (group A) and compared to those of patients < 70 years (group B). RESULTS: Out of a total of 2907 patients, 1158 (39.8%) were > or =70 years of age. Among these, 17.1% were admitted as a result of an ADE vs. 13.2% in group B (p = 0.004). ADE appeared to be more severe in group A than in group B. The part of preventable ADE did not significantly differ between the two groups (48.9% vs. 43.7%, respectively). CONCLUSION: ADE are a common preventable cause of unplanned admissions, especially in the elderly.

[Not Available]. / Admissions des sujets âgés aux Services d'Accueil des Urgences pour effets indésirables médicamenteux.

AIMS: To investigate the characteristics of adverse drug events (ADE) causing emergency medical admissions in the elderly. METHODS: Data were obtained from two prospective cross sectional studies with similar experimental design which were carried out in seven French emergency departments in 1999 and 2003. The proportion of ADE leading to admission, their severity and preventability were assessed in patients aged ≥70 (group A) and compared to those of patients <70years (group B). RESULTS: Out of a total of 2907 patients, 1158 (39.8%) were ≥70years of age. Among these, 17.1% were admitted as a result of an ADE vs. 13.2% in group B (p=0.004). ADE appeared to be more severe in group A than in group B. The part of preventable ADE did not significantly differ between the two groups (48.9% vs. 43.7%, respectively). CONCLUSION: ADE are a common preventable cause of unplanned admissions, especially in the elderly.