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ImportanceBefore surgery, the best strategy for managing patients who are taking renin-angiotensin system inhibitors (RASIs) (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) is unknown. The lack of evidence leads to conflicting guidelines.ObjectiveTo evaluate whether a continuation strategy vs a discontinuation strategy of RASIs before major noncardiac surgery results in decreased complications at 28 days after surgery.Design, setting, and participantsRandomized clinical trial that included patients who were being treated with a RASI for at least 3 months and were scheduled to undergo a major noncardiac surgery between January 2018 and April 2023 at 40 hospitals in France.InterventionPatients were randomized to continue use of RASIs (n = 1107) until the day of surgery or to discontinue use of RASIs 48 hours prior to surgery (ie, they would take the last dose 3 days before surgery) (n = 1115).Main outcomes and measuresThe primary outcome was a composite of all-cause mortality and major postoperative complications within 28 days after surgery. The key secondary outcomes were episodes of hypotension during surgery, acute kidney injury, postoperative organ failure, and length of stay in the hospital and intensive care unit during the 28 days after surgery.ResultsOf the 2222 patients (mean age, 67 years [SD, 10 years]; 65% were male), 46% were being treated with angiotensin-converting enzyme inhibitors at baseline and 54% were being treated with angiotensin receptor blockers. The rate of all-cause mortality and major postoperative complications was 22% (245 of 1115 patients) in the RASI discontinuation group and 22% (247 of 1107 patients) in the RASI continuation group (risk ratio, 1.02 [95% CI, 0.87-1.19]; P = .85). Episodes of hypotension during surgery occurred in 41% of the patients in the RASI discontinuation group and in 54% of the patients in the RASI continuation group (risk ratio, 1.31 [95% CI, 1.19-1.44]). There were no other differences in the trial outcomes.Conclusions and relevanceAmong patients who underwent major noncardiac surgery, a continuation strategy of RASIs before surgery was not associated with a higher rate of postoperative complications than a discontinuation strategy.Trial registrationClinicalTrials.gov Identifier: NCT03374449.

Résumé: Les concentrés de complexe prothrombinique (CCP) sont utilisés lors d'hémorragies dans un contexte de surdosage en antivitamines K (AVK) ou d'une chirurgie d'urgence chez les patients sous AVK ou anticoagulants oraux directs (AOD) (recommandations du Groupe d'intérêt en hémostase périopératoire [GIHP]). Face à une augmentation de la consommation et afin d'évaluer le bon usage de ces complexes, une étude rétrospective a été menée sur une année d'administration dans notre centre hospitalier. Les dossiers concernés ont été analysés afin de caractériser le contexte clinique, les paramètres biologiques à l'admission et la conformité des doses prescrites. La cohorte comporte 79 patients dont 54 % sous AVK et 33 % admis pour hémorragie cérébrale. La posologie de CCP a été jugée conforme pour 62 % des patients. Les 38 % de non-conformités étaient répartis en 85 % de sous-dosage du CCP et deux antagonisations non nécessaires (7 %). Les sous-dosages n'ont pas eu d'impact clinique (absence de saignement dans les comptes rendus opératoires, efficacité clinique et biologique). Même si les recommandations du GIHP permettent d'encadrer l'utilisation du CCP, il est assez difficile pour les cliniciens de proposer un report d'intervention, en prenant en compte le risque potentiel d'aggravation clinique liée au retard de prise en charge. Enfin, avec une population obèse croissante (17 patients [21 %] ayant un poids ≥ 90 kg), de nouvelles données scientifiques doivent venir modifier les résumés des caractéristiques du produit (RCP) ou les protocoles d'utilisation des CCP, afin de garantir l'efficacité et la sécurité de ces patients. Prothrombinic complex concentrates (PCC) are used during antivitamin K (VKA) overdose or emergency surgery in patients on direct oral anticoagulants (DOA) (GIHP recommendations). Faced with an increase in consumption and in order to evaluate the proper use of these complexes, a retrospective study was conducted over one year of administration. The files concerned were analyzed in order to characterize the clinical context, the biological parame ters at admission and the compliance of the prescribed doses. The cohort included 79 patients, 54 % of whom were on VKA and 33 % admitted for cerebral hemorrhage. CCP dosage was considered compliant for 62 % of patients. Non-compliances corresponded to underdosing of the PCC (85 %) and two unnecessary antagonizations (7 %). The underdosing had no clinical impact (absence of bleeding in the operative reports, clinical and biological effectiveness). Although the GIHP recommendations provide a framework for the use of PCC, it is quite difficult for clinicians to assess life-threatening urgency and to propose a postponement of intervention. Finally, with an increasing obese population (17 patients with a weight ≥ 90 kg), new scientific data must come to modify the PCC or protocols for the use of PCC in order to guarantee the effectiveness and safety of these patients. [ABSTRACT FROM AUTHOR]

Résumé: Avec la pandémie de SARS-CoV-2, dans notre établissement, les lits de salle de surveillance post-interventionnelle du bloc opératoire ont été transformés en lits de réanimation non-COVID. Le service de pharmacie a accompagné les équipes au cours des trois périodes, avec la mise en place d'un circuit du médicament adapté : création d'une armoire de dotation, fréquence d'approvisionnement, dispensation nominative et présence pharmaceutique. Objectifs : évaluer l'organisation pharmaceutique mise en place, la satisfaction des équipes infirmiers et recueillir des axes d'amélioration. Méthode : un questionnaire a été remis aux infirmiers ayant travaillé dans cette unité. Résultats : au total, 155 patients, soit une analyse de 111 prescriptions, ont été pris en charge sur 126 jours d'ouverture de cette unité. L'ensemble des infirmiers ayant participé aux trois périodes ainsi que le cadre de santé ont complété le questionnaire, soit 21 réponses. L'étape ressentie comme la plus difficile est la prescription (48 %) liée au support papier utilisé. La présence pharmaceutique a été appréciée à 90 %, notamment pour des demandes d'approvisionnement d'un médicament (95 %), ou d'information sur un médicament (58 %). Il est souhaité (90 %) que cette présence soit renouvelée en cas de réouverture de l'unité. Une amélioration de la satisfaction est constatée à chaque période. Conclusion : en cas de nouvelle vague, il a été décidé de poursuivre le détachement d'un pharmacien pour sécuriser le fonctionnement de ce type d'unité, notamment par l'analyse quotidienne des prescriptions avec les médecins et par l'interaction avec les infirmiers pour le bon usage du médicament. During the SARS CoV-2 pandemia and at three separate time period, our institution chose to turn the post interventional surveillance room of the operating room into a non-COVID intensive care unit. The chosen workflow included that the pharmacy team provided support to the medical team and was instrumental to implement an adapted drug circuit, including the creation of a supply cabinet, a specific frequency of its supply, a nominative dispensation and the presence of a pharmacist. Objectives : The study aims to evaluate the proposed pharmaceutical organization workflow, the satisfaction of the nursing team and to collect their expert feedback for improvement. Method : A satisfaction survey questionnaire was set up and given to the nurses who worked in this temporary unit. Results : A total of 155 patients, i.e. an analysis of 111 prescriptions, were treated during the 126 days during which the unit was running. All the nurses who participated to the three time periods and the health care manager completed the questionnaire, i.e. 21 responses. The step that was felt to be the most difficult was prescribing (48%) due to the paper medium used. The presence of a pharmacist in the medical unit was appreciated by 90% of the survey respondents, particularly for requests on the supply of a drug (95%), or on drug information (58%). 90% of the respondents were hoping that this experience would be renewed if the unit opens again. An increase of the satisfaction due to the pharmaceutical presence is reported in each successive period. Conclusion : In case of an eventual new epidemic wave, it was decided to continue to assign a pharmacist to the non-COVID intensive care unit, in order to protect the unit performance. The survey revealed that two key factor are instrumental to this success, a daily analysis of prescriptions with the physicians and the on-site interaction with the nurses for the promotion of the right use of medications. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to describe the evolution of transfusion practices following the introduction of tranexamic acid (TXA) and ROTEM® in a trauma resuscitation unit (TRU) from a French teaching hospital (FTH). Methods: This is a single-centre, retrospective study at a TRU from a FTH. All trauma patients aged 18 years or more and transfused with at least 4 red blood cells (RBCs) within 24 hours after trauma, from 2011 to 2016, were included. The primary objective was to analyse transfusion practices over this time period. The secondary objectives aimed at assessing differences between populations according to the fresh frozen plasma (FFP):RBC ratio applied. Results: A total of 122 patients were included. There was a significant decrease in the proportion of patients requiring at least 4 RBCs 24 hours after trauma (9% vs. 3%, P trend < .0001) as well as a decrease in the proportion of patients with a high FFP:RBC ratio (86% vs. 62% at 6 hours, P trend = .0056 and 86% vs. 56% at 24 hours, P trend = .0047). After 2013, fibrinogen was administered to more than 70% of patients and TXA to 100% of them. The observed mortality was lower than the predicted one, irrespective of FFP:RBC ratio. Conclusion: An important evolution of practices occurred including a decrease in the proportion of transfusions and use of high FFP:RBC ratios. The origin of these changes is multifactorial, likely including the systematic use of TXA and optimisation of the ROTEM protocol for fibrinogen administration. [ABSTRACT FROM AUTHOR]