First evidence of the induction of domoic acid production in Pseudo-nitzschia australis by the copepod Temora longicornis from the French coast.

Diatoms of the genus Pseudo-nitzschia are widespread in marine waters. Some of them can produce the toxin domoic acid (DA) which can be responsible for amnesic shellfish poisoning (ASP) when transferred into the food web. These ASP events are of major concern, due to their ecological and socio-economic repercussions, particularly on the shellfish industry. Many studies have focused on the influence of abiotic factors on DA induction, less on the role of biotic interactions. Recently, the presence of predators has been shown to increase DA production in several Pseudo-nitzschia species, in particular in Arctic areas. In order to investigate the relationship between Pseudo-nitzschia species and grazers from the French coast, exposures between one strain of three species (P. australis, P. pungens, P. fraudulenta) and the copepod Temora longicornis were conducted for 5 days. Cellular and dissolved DA content were enhanced by 1,203 % and 1,556 % respectively after the 5-days exposure of P.australis whereas no DA induction was observed in P. pungens and P. fraudulenta. T. longicornis consumed all three Pseudo-nitzschia species. The copepod survival was not related to DA content. This study is an essential first step to better understanding the interactions between planktonic species from the French coast and highlights the potential key role of copepods in the Pseudo-nitzschia bloom events in the temperate ecosystems.

Opioid-free anaesthesia with dexmedetomidine and lidocaine versus remifentanil-based anaesthesia in cardiac surgery: study protocol of a French randomised, multicentre and single-blinded OFACS trial.

INTRODUCTION: Intraoperative opioids have been used for decades to reduce negative responses to nociception. However, opioids may have several, and sometimes serious, adverse effects. Cardiac surgery exposes patients to a high risk of postoperative complications, some of which are common to those caused by opioids: acute respiratory failure, postoperative cognitive dysfunction, postoperative ileus (POI) or death. An opioid-free anaesthesia (OFA) strategy, based on the use of dexmedetomidine and lidocaine, may limit these adverse effects, but no randomised trials on this issue have been published in cardiac surgery.We hypothesised that OFA versus opioid-based anaesthesia (OBA) may reduce the incidence of major opioid-related complications after cardiac surgery. METHODS AND ANALYSIS: Multicentre, randomised, parallel and single-blinded clinical trial in four cardiac surgical centres in France, including 268 patients scheduled for coronary artery bypass grafting under cardiac bypass, with or without aortic valve replacement. Patients will be randomised to either a control OBA protocol using remifentanil or an OFA protocol using dexmedetomidine/lidocaine. The primary composite endpoint is the occurrence of at least one of the following: (1) postoperative cognitive disorder evaluated by the Confusion Assessment Method for the Intensive Care Unit test, (2) POI, (3) acute respiratory distress or (4) death within the first 48 postoperative hours. Secondary endpoints are postoperative pain, morphine consumption, nausea-vomiting, shock, acute kidney injury, atrioventricular block, pneumonia and length of hospital stay. ETHICS AND DISSEMINATION: This trial has been approved by an independent ethics committee (Comité de Protection des Personnes Ouest III-Angers on 23 February 2021). Results will be submitted in international journals for peer reviewing. TRIAL REGISTRATION NUMBER: NCT04940689, EudraCT 2020-002126-90.

Predictors of health-related quality of life in a large cohort of adult patients living with sickle cell disease in France: the DREPAtient study.

Background: Sickle cell disease (SCD) is an inherited autosomal recessive disorder exhibiting a range of symptoms and acute and/or chronic complications that affect the quality of life. This study aimed to assess health-related quality of life (HRQoL) and to identify the associated factors in adult patients with SCD in France. Methods: DREPAtient is a cross-sectional, multicenter study conducted from June 2020 to April 2021 in France and in certain French overseas territories where SCD is highly prevalent. Sociodemographic and clinical data were collected online. HRQoL was assessed by the French version of the 36-Item Short Form Survey (SF-36) questionnaire. HRQoL determinants were identified using multivariable linear regression analysis. Results: In total, 570 participants were included, mostly women (68.9%), with a mean age of 33.3 (±10.7) years. The highest mean score HRQoL was found in the Physical functioning domain (67.5 ± 21.8) and the lowest mean score in the General Health perception domain (37.7 ± 20.3). The mean score of the physical composite (PCS) and mental composite (MCS) of SF-36 summary scores was 40.6 ± 8.9 and 45.3 ± 9.8, respectively. Participants receiving oxygen therapy (ß = -3.20 [95%CI: -5.56; -0.85]), those with a history of femoral osteonecrosis (-3.09 [-4.64; -1.53]), those hospitalized for vaso-occlusive crisis (VOC) or acute chest syndrome (ACS) (-2.58 [-3.93; -1.22]), those with chronic complications (-2.33 [-4.04; -0.62]), female participants (-2.17 [-3.65; -0.69]), those with psychological follow-up (-2.13 [-3.59; -0.67]), older participants (-1.69 [-3.28; -0.09]), and those receiving painkillers (-1.61 [-3.16; -0.06]) reported worse PCS score. By contrast, those who had completed secondary or high school (4.36 [2.41; 6.31]) and those with stable financial situation (2.85 [0.94, 4.76]) reported better PCS scores. Worse MCS scores were reported among participants with psychological follow-up (-2.54 [-4.28; -0.80]) and those hospitalized for VOC/ACS in the last 12 months (-2.38 [-3.99; -0.77]), while those who had relatives' support (5.27 [1.92; 8.62]) and those with stable financial situation (4.95 [2.65; 7.26]) reported better MCS scores. Conclusion: Adults with major SCD reported poor physical and mental HRQoL scores. Hospitalization for VOC/ACS, chronic complications, use of painkillers, perceived financial situation, and support from relatives are important predictors of HRQoL in SCD patients. Interventions to improve HRQoL outcomes SCD should be considered.

Two Decades of Publications in Journals Dedicated to Autoimmunity: A Bibliometric Analysis of the Autoimmunity Field from 2004 to 2023.

To carry out an in-depth analysis of the scientific research on autoimmunity, we performed the first bibliometric analysis focusing on publications in journals dedicated to autoimmunity (JDTA) indexed by science citation index during the period 2004-2023. Using bibliometric analysis, we quantitatively and qualitatively analyzed the country, institution, author, reference and keywords information of publications in JDTA, so as to understand the quantity, publication pattern and publication characteristics of these publications. The co-occurrence networks, clustering map and timeline map were created by CiteSpace and VOSviewer software to visualize the results. The CiteSpace was also used to analyze the strongest citation burst of keywords, which could describe the frequency, intensity and time period of high-frequency keywords, and indicate the research hotspots in the field. A total of 5 710 publications were analyzed, and their annual distribution number was basically stable from 2004 to 2023, fluctuating around 300. The United States and Italy led the way in terms of the number of publications, followed by France and China. For international cooperation, the developed countries represented by the United States cooperate more closely, but the cooperation was localized, reflecting that there was no unified model of autoimmunity among countries. UDICE-French Research Universities had the greatest number of publications. Subsequently, the number of publications decreased slowly with the ranking, and the gradient was not large. Eric Gershwin and Yehuda Shoenfeld stood out among the authors. They had an excellent academic reputation and great influence in the field of autoimmunity. The results of keyword analysis showed that JDTA publications mainly studied a variety of autoimmune diseases, especially SLE and RA. At the same time, JDTA publications also paid special attention to the research of cell function, autoantibody expression, animal experiments, disease activity, pathogenesis and treatment. This study is the first to analyze the publications in JDTA from multiple indicators by bibliometrics, thus providing new insights into the research hotspots and development trends in the field of autoimmunity.

[Health care organization for 2024 Olympics and Paralympics Games]. / Organisation du système de soins pour les Jeux olympiques et paralympiques 2024.

HEALTH CARE ORGANIZATION FOR 2024 OLYMPICS AND PARALYMPICS GAMES. The 2024 olympic and paralympic Games (JOP 2024) constitute the largest global festive event. While this major international gathering is primarily synonymous with celebrations, health security represents a major challenge for the French healthcare system in a highly tense national and international context. The health security of the JOP 2024 relies on close collaboration between the medical service of the organizer Paris 2024, responsible for care at the Olympic sites, and state services (SAMU, Law Enforcement, Firefighters) providing support in the event of serious health incidents or exceptional health situations (SSE). The projected impact on our healthcare structures (excluding SSE) appears moderate, as a 5% increase in hospital activity and approximately 150 additional daily emergencies are expected during the Olympic period compared to a normal summer season. In the event of a major incident resulting in a large number of casualties, state services will take over the governance of relief efforts by activating the ORSEC-NOVI and ORSAN-AMAVI plans for health response. The preparation of this health coverage involves an unprecedented mobilization of all healthcare stakeholders and is manifested by the organization of exercises at a very brisk pace.

ORGANISATION DU SYSTÈME DE SOINS POUR LES JEUX OLYMPIQUES ET PARALYMPIQUES 2024. Les Jeux olympiques et paralympiques 2024 (JOP 2024) constituent le plus important événement festif mondial. Si ce grand rassemblement international se veut avant tout synonyme de fête, la sécurité sanitaire représente un enjeu majeur pour le système de soins français, dans un contexte national et international en tension majeure. La sécurité sanitaire des JOP 2024 relève d'une étroite collaboration entre le service médical de l'organisateur Paris 2024, responsable des soins sur les sites olympiques, et les services de l'État (Samu, forces de l'ordre, sapeurs-pompiers) venant en soutien en cas d'événements sanitaires graves ou en cas de situation sanitaire exceptionnelle. La prévision de l'impact sur les structures sanitaires (en dehors de situation sanitaire exceptionnelle) semble modérée, puisque l'on attend une augmentation de 5 % de l'activité hospitalière et environ 150 urgences journalières de plus pendant la période olympique par rapport à une saison estivale normale. En cas d'événement majeur générant un grand nombre de victimes, les services de l'État prendront la gouvernance des secours par le déclenchement des plans ORSECNOVI et ORSAN-AMAVI pour la valence sanitaire. La préparation de cette couverture sanitaire fait appel à une mobilisation sans précédent de tous les acteurs de santé et se concrétise par l'organisation d'exercices à un r ythme très soutenu.

[Pollution attributable mortality]. / Mortalité attribuable à la pollution.

POLLUTION ATTRIBUTABLE MORTALITY. Pollution is estimated to be responsible for 9 million premature deaths per year in the world. For each cause of death with a risk increased by a pollutant, the number of deaths attributable to it is computed by comparison with the number of deaths expected under a reference pollution level, which is 10 µg/m3 for ambient particulate matter pollution. Only 8% of the deaths attributable to pollution occur in high income countries, because of the large effects of water and indoor air pollution (caused by traditional cooking methods) in low and middle-income countries. In France, by this method, one estimates that 13.200 deaths a year are attributable to ambient particulate matter pollution and 1.100 to ozone. Santé publique France, which has concluded that 48.000 deaths a year were attributable to air pollution in France, overvalues the risk by a factor of nearly 4 by overestimating the risks associated with air pollution and taking a utopian reference scenario.

MORTALITÉ ATTRIBUABLE À LA POLLUTION. On estime que la pollution est responsable de 9 millions de décès prématurés par an dans le monde. Pour chaque cause de décès dont le risque est augmenté par la pollution, un nombre de décès attribuable à la pollution est calculé par comparaison avec le nombre attendu pour un niveau de pollution de référence qui est de 10 µg/m3 pour la pollution particulaire de l'air extérieur. Seulement 8 % des décès attribuables à la pollution surviennent dans les pays à revenu élevé (effets importants des pollutions de l'eau et de l'air intérieur par des modes de cuisson traditionnels dans les pays à revenus bas ou moyens). En France, par cette méthode, on estime que 13 200 décès par an sont liés à la pollution particulaire de l'air extérieur et 1 100 à l'ozone. Santé publique France, qui conclut que 48 000 décès par an sont attribuables à la pollution de l'air en France, surévalue donc le risque d'un facteur proche de 4 en surestimant l'effet de la pollution et en prenant une pollution de référence utopique.

[Occupational medicine in France: the current situation in 2024]. / Médecine du travail en France, état des lieux en 2024.

OCCUPATIONAL MEDICINE IN France : THE CURRENT SITUATION IN 2024. Occupational medicine has evolved since its creation in 1946. Occupational medicine services have become Occupational health services (OHS) and medical examination in nowadays only a part of their missions, which include helping the employers to perform risk assessment, patients to stay at work, and implementing health promotion in the workplaces in order to prevent disabilities. To fulfill those missions, OHS can rely on health specialists (occupational physicians and nurses) but also on a wide range of competencies, from toxicologists to ergonomists, and from psychologists to occupational hygiene specialists, all gathered in multidisciplinary teams, leaded by the occupational physician. Optimizing cooperation between general practitioners and occupational health physicians is still needed to improve the worker journey, to facilitate his ability to return to work and to ameliorate his long-term health follow-up according to his previous occupational exposures.

MÉDECINE DU TRAVAIL EN FRANCE, ÉTAT DES LIEUX EN 2024. La médecine du travail a peu à peu évolué, depuis sa création en 1946. Les services médicaux du travail sont devenus des services de prévention et de santé au travail, et le suivi de santé ne représente désormais qu'une partie de leur activité. L'aide à l'évaluation des risques, le maintien en emploi, les actions de promotion de la santé dans une perspective de prévention de la désinsertion professionnelle ont pris une place grandissante. Cela s'est accompagné d'une évolution des compétences au sein de ces services. Outre la compétence santé représentée par le binôme médecin-infirmier, des ergonomes, psychologues et toxicologues sont désormais présents ; ils interviennent en prévention des risques professionnels et constituent des équipes pluridisciplinaires, animées et coordonnées par le médecin du travail. Une meilleure collaboration entre médecin du travail et médecin traitant reste nécessaire pour améliorer le parcours du travailleur, son maintien en emploi et son suivi de santé au long cours en fonction de ses expositions professionnelles passées.

[Specific aspects of medico-social protection in French public services]. / Aspects spécifiques de la protection médico-sociale en fonctions publiques.

SPECIFIC ASPECTS OF MEDICO-SOCIAL PROTECTION IN FRENCH PUBLIC SERVICES. Civil servants in the three French civil services (State, hospital and local governments) benefit from specific medical and social protection, unique to their status. This protection is very different from that of private sector workers under the French general social security regime, with specific participants and instances (licensed doctors and "conseils médicaux") and specific sick leave depending on the pathology of the civil servant, in particular long-term sick leave ("congés de longue maladie"), long-term leave ("congés de longue durée") and leave for temporary disability attributable to the service. Therapeutic part-time leave also has specific conditions for granting and renewal. Finally, civil servants benefit from specific measures for returning to and remaining in employment, particularly in the context of professional reclassification.

ASPECTS SPÉCIFIQUES DE LA PROTECTION MÉDICO-SOCIALE EN FONCTIONS PUBLIQUES. Les fonctionnaires des trois fonctions publiques (d'État, hospitalière et territoriale) bénéficient d'une protection médico-sociale spécifique, propre à leur statut. Celle-ci est très différente de celle des travailleurs du secteur privé dépendant du régime général de la Sécurité sociale : intervenants et instances spécifiques (médecins agréés et conseils médicaux) ; congés de maladie particuliers en fonction de la pathologie du fonctionnaire, notamment les congés de longue maladie, les congés de longue durée et les congés pour invalidité temporaire imputable au service. Le temps partiel thérapeutique a également des conditions d'octroi et de renouvellement dédiées. Enfin, les fonctionnaires bénéficient de mesures pour le retour et le maintien en emploi qui leur sont propres, notamment dans le cadre du reclassement professionnel.

[Post-hospital support for families: current situation and outlook]. / L'accompagnement posthospitalier des familles : état des lieux et perspectives.

After neonatal hospitalization, our healthcare system offers multidisciplinary care for premature babies and their families during the first years of life. However, there are disparities and gaps, particularly in the case of medium prematurity. Maternal and child protection, a major player in early prevention and family follow-up, is a partner likely to be able to deploy post-hospital support perspectives in favor of child development and parenting support.

Population-based study of eclampsia: Lessons learnt to improve maternity care.

BACKGROUND: Among hypertensive disorders of pregnancy (HDP), eclampsia is a rare but serious event, often considered avoidable. Detailed assessment of the adequacy of care for the women who have eclampsia can help identify opportunities for improvement and for prevention of the associated adverse maternal and neonatal outcomes. OBJECTIVE: 1/ To estimate the incidence and describe the characteristics of women with eclampsia and to compare them with those of women with non-eclamptic hypertensive disorders of pregnancy (HDP)-related severe maternal morbidity (SMM) and of control women without SMM 2/ To analyse the quality of management in women who had eclampsia, at various stages of their care pathway. METHODS: It was a planned ancillary analysis of the EPIMOMS population-based study, conducted in six French regions in 2012-2013. Among the 182,309 maternities of the source population, all women with eclampsia (n = 51), with non-eclamptic HDP-related SMM (n = 351) and a 2% representative sample of women without SMM (n = 3,651) were included. Main outcome was the quality of care for eclampsia assessed by an independent expert panel at three different stages of management: antenatal care, care for pre-eclampsia and care for eclampsia. RESULTS: The eclampsia incidence was 2.8 per 10,000 (95%CI 2.0-4.0). Antenatal care was considered completely inadequate or substandard in 39% of women, as was pre-eclampsia care in 76%. Care for eclampsia was judged completely inadequate or substandard in 50% (21/42), mainly due to inadequate use of magnesium sulphate. CONCLUSION: The high proportion of inadequate quality of care underlines the need for an evidence-based standardisation of care for HDP.

Medically Assisted Reproduction and Risk of Cancer Among Offspring.

Importance: Cancer is a leading cause of death among children worldwide. Treatments used for medically assisted reproduction (MAR) are suspected risk factors because of their potential for epigenetic disturbance and associated congenital malformations. Objective: To assess the risk of cancer, overall and by cancer type, among children born after MAR compared with children conceived naturally. Design, Setting, and Participants: For this cohort study, the French National Mother-Child Register (EPI-MERES) was searched for all live births that occurred in France between January 1, 2010, and December 31, 2021 (and followed up until June 30, 2022). The EPI-MERES was built from comprehensive data of the French National Health Data System. Data analysis was performed from December 1, 2021, to June 30, 2023. Exposure: Use of assisted reproduction technologies (ART), such as fresh embryo transfer (ET) or frozen ET (FET), and artificial insemination (AI). Main Outcomes and Measures: The risk of cancer was compared, overall and by cancer type, among children born after fresh ET, FET, or AI and children conceived naturally, using Cox proportional hazards regression models adjusted for maternal and child characteristics at birth. Results: This study included 8 526 306 children with a mean (SD) age of 6.4 (3.4) years; 51.2% were boys, 96.4% were singletons, 12.1% were small for gestational age at birth, and 3.1% had a congenital malformation. There were 260 236 children (3.1%) born after MAR, including 133 965 (1.6%) after fresh ET, 66 165 (0.8%) after FET, and 60 106 (0.7%) after AI. A total of 9256 case patients with cancer were identified over a median follow-up of 6.7 (IQR, 3.7-9.6) years; 165, 57, and 70 were born after fresh ET, FET, and AI, respectively. The overall risk of cancer did not differ between children conceived naturally and those born after fresh ET (hazard ratio [HR], 1.12 [95% CI, 0.96 to 1.31]), FET (HR, 1.02 [95% CI, 0.78 to 1.32]), or AI (HR, 1.09 [95% CI, 0.86 to 1.38]). However, the risk of acute lymphoblastic leukemia was higher among children born after FET (20 case patients; HR 1.61 [95% CI, 1.04 to 2.50]; risk difference [RD], 23.2 [95% CI, 1.5 to 57.0] per million person-years) compared with children conceived naturally. Moreover, among children born between 2010 and 2015, the risk of leukemia was higher among children born after fresh ET (45 case patients; HR, 1.42 [95% CI, 1.06 to 1.92]; adjusted RD, 19.7 [95% CI, 2.8 to 43.2] per million person-years). Conclusions and Relevance: The findings of this cohort study suggest that children born after FET or fresh ET had an increased risk of leukemia compared with children conceived naturally. This risk, although resulting in a limited number of cases, needs to be monitored in view of the continuous increase in the use of ART.

The adapted French version of the Academic and Athletic Identity Scale (AAIS-FR): Evidence of validity and reliability and relationships with sport well-being.

BACKGROUND: Effectively managing their athletic and academic projects is a major challenge for student-athletes. The salience of the identity they develop in each of these contexts can affect their well-being and is therefore an important variable to consider. Examining these mechanisms in countries and student-athlete support systems other than the United States is also important. AIM: This study aims to both translate and evaluate the psychometric properties of a French version of the Academic and Athletic Identity Scale, the AAIS-FR, and to examine the additive and interactive relationships of the two identities with sport burnout and engagement. METHODS: Participants were 359 French student-athletes (50.42% female) who were competing at various levels (ranging from regional to international). RESULTS: Results from analyses using a slightly modified version of the original scale provided evidence of construct (i.e., factor structure) and concurrent (i.e., expected relationships between both identities and several correlates identified in previous work) validity, as well as reliability (i.e., internal consistency) and invariance across gender and sport competition levels of the AAIS-FR. In addition, regression analyses revealed a favourable relationship between athletic identity and sport well-being (i.e., positive with engagement and negative with burnout), no relationship between academic identity and sport well-being, and no interaction between the two identities. CONCLUSION: While further research is needed to provide additional evidence for the validity of the AAIS-FR, researchers can still use this tool to measure the salience of the two identities of French-speaking student-athletes.

Discovery of a series of portimine-A fatty acid esters in mussels.

Vulcanodinium rugosum is a benthic dinoflagellate known for producing pinnatoxins, pteriatoxins, portimines and kabirimine. In this study, we aimed to identify unknown analogs of these emerging toxins in mussels collected in the Ingril lagoon, France. First, untargeted data acquisitions were conducted by means of liquid chromatography coupled to hybrid quadrupole-orbitrap mass spectrometry. Data processing involved a molecular networking approach, and a workflow dedicated to the identification of biotransformed metabolites. Additionally, targeted analyses by liquid chromatography coupled to triple quadrupole mass spectrometry were also implemented to further investigate and confirm the identification of new compounds. For the first time, a series of 13-O-acyl esters of portimine-A (n = 13) were identified, with fatty acid chains ranging between C12:0 and C22:6. The profile was dominated by the palmitic acid conjugation. This discovery was supported by fractionation experiments combined with the implementation of a hydrolysis reaction, providing further evidence of the metabolite identities. Furthermore, several analogs were semi-synthesized, definitively confirming the discovery of these metabolization products. A new analog of pinnatoxin, with a molecular formula of C42H65NO9, was also identified across the year 2018, with the highest concentration observed in August (4.5 µg/kg). The MS/MS data collected for this compound exhibited strong structural similarities with PnTX-A and PnTX-G, likely indicating a substituent C2H5O2 in the side chain at C33. The discovery of these new analogs will contribute to deeper knowledge of the chemodiversity of toxins produced by V. rugosum or resulting from shellfish metabolism, thereby improving our ability to characterize the risks associated with these emerging toxins.

Spatio-temporal connectivity of a toxic cyanobacterial community and its associated microbiome along a freshwater-marine continuum.

Due to climate changes and eutrophication, blooms of predominantly toxic freshwater cyanobacteria are intensifying and are likely to colonize estuaries, thus impacting benthic organisms and shellfish farming representing a major ecological, health and economic risk. In the natural environment, Microcystis form large mucilaginous colonies that influence the development of both cyanobacterial and embedded bacterial communities. However, little is known about the fate of natural colonies of Microcystis by salinity increase. In this study, we monitored the fate of a Microcystis dominated bloom and its microbiome along a French freshwater-marine gradient at different phases of a bloom. We demonstrated changes in the cyanobacterial genotypic composition, in the production of specific metabolites (toxins and compatible solutes) and in the heterotrophic bacteria structure in response to the salinity increase. In particular M. aeruginosa and M. wesenbergii survived salinities up to 20. Based on microcystin gene abundance, the cyanobacteria became more toxic during their estuarine transfer but with no selection of specific microcystin variants. An increase in compatible solutes occurred along the continuum with extensive trehalose and betaine accumulations. Salinity structured most the heterotrophic bacteria community, with an increased in the richness and diversity along the continuum. A core microbiome in the mucilage-associated attached fraction was highly abundant suggesting a strong interaction between Microcystis and its microbiome and a likely protecting role of the mucilage against an osmotic shock. These results underline the need to better determine the interactions between the Microcystis colonies and their microbiome as a likely key to their widespread success and adaptation to various environmental conditions.

Efficacy of ferric carboxymaltose on haemoglobin response among older patients with gastrointestinal bleeding: a randomised clinical trial.

BACKGROUND: Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied. AIMS: This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB. METHODS: This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65 years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9-11 g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180. RESULTS: From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49 g/dl in the ferric carboxymaltose group vs. 1.56 g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups. CONCLUSIONS: Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585).