13 results on '"Jean-Marie Chretien"'
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2. A software tool to support follow-up care in a French childhood cancer cohort: construction and feasibility
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Charlotte Demoor-Goldschmidt, Pascal Veillon, Maxime Esvan, Mathilde Leonard, Sophie Chauvet, Amandine Bertrand, Liana Carausu, Fanny Delehaye, Julien Lejeune, Jérémie Rouger, Pascale Schneider, Caroline Thomas, Frédéric Millot, Line Claude, Julie Leseur, Fernand Missohou, Stéphane Supiot, Nathalie Bihannic, Isabelle Debroise, Carole Jeanneaud, Esther Lebreton, Marianne Roumy, Les Aguerris, Jean-Marie Chrétien, Virginie Gandemer, and Isabelle Pellier
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Database ,Medical tool ,Personalized survivorship care plan ,Childhood cancer ,Adolescent cancer ,Survivorship ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background Treatment summaries and a personalized survivorship care plans based on internationally approved, organ-specific follow-up care recommendations are essential in preserving the health and quality of life for cancer survivors. Cohorts made up of survivors of childhood cancer have made significant contributions to the understanding of early mortality, somatic late complications, and psychosocial outcomes among former patients. New treatment protocols are needed to enhance survival and reduce the potential risk and severity of late effects, and working with treatment databases is crucial in doing so. Construction and content In the GOCE (Grand Ouest Cancer de l’Enfant [Western Region Childhood Cancer]) network, in a participative approach, we developed the LOG-after medical tool, on which health data are registered and can be extracted for analysis. Its name emphasizes the tool’s goal, referring to ‘logiciel’ (the French word for software) that focuses on the period “after” the acute phase. This tool is hosted on a certified health data server. Several interfaces have been developed that can be used depending on the user’s profile. Here we present this innovative co-constructed tool that takes national aspects into account, including the results of the feasibility/satisfaction study and its perspective. Utility and discussion The database contains data relating to 2558 patients, with samples from 1702 of these (66.54%) being held in a tumor bank. The average year in which treatment started was 2015 (ranging from December 1967 to November 2022: 118 patients were treated before 2012 and registered retrospectively when seen in long-term follow-up consultations or for another cancer since November 2021). A short questionnaire was distributed to healthcare professionals using the tool (physicians and research associates or technicians, n = 14), of whom 11 answered and were all satisfied. Access to the patient interface is currently open to 124 former patients. This was initially offered to 30 former patients who were over 15 years old, affected by the disease within the last 5 years, and had agreed to test it. Their opinions were collected by their doctor by e-mail, telephone, or during a consultation in an open-ended question and a non-directive interview. All patients were satisfied with the tool, with interest in testing it in the long term. Some former patients found that the tool provided them with some ease of mind; one, for instance, commented: "I feel lighter. I allow myself to forget. I know I will get a notification when the time comes." Conclusions Freely available to all users, LOG-after: (1) provides help with determining personalized survivorship care plans for follow-up; (2) builds links with general practitioners; (3) empowers the patient; and (4) enables health data to be exported for analysis. Database URL for presentation: https://youtu.be/2Ga64iausJE
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- 2024
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3. Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study
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Andrea Penaloza, Quentin Delmez, Olivier Sanchez, N. Delvau, Nicolas Marjanovic, Alexandre Ghuysen, Jeannot Schmidt, Thomas Moumneh, Farès Moustafa, Christian Brice, Philippe Girard, Guy Meyer, Grégoire Le Gal, Béatrice Gable, Jacques Bouget, Lionel Imsaad, Caroline Soulie, Pierre-Marie Roy, Catherine Le Gall, A Trinh-Duc, Dominique El Kouri, Jean-Marie Chretien, Service des Urgences [CHU Nantes], Hôtel-Dieu de Nantes, Modélisation Conceptuelle des Connaissances Biomédicales, Université de Rennes (UR), Département des Urgences, CHU Clermont-Ferrand, Service d'Accueil des Urgences (AGEN - SAU), Centre Hospitalier d'Agen, Centre Hospitalier Victor Dupouy, Délégation à la recherche clinique et innovation, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Laboratoire de l'intégration, du matériau au système (IMS), Université Sciences et Technologies - Bordeaux 1 (UB)-Institut Polytechnique de Bordeaux-Centre National de la Recherche Scientifique (CNRS), Unité de soins intensifs [Clermont Ferrand], CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre de Recherche Clinique (CRC Angers), Université d'Angers (UA)-Centre Hospitalier Universitaire d'Angers (CHU Angers), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Université Sciences et Technologies - Bordeaux 1-Institut Polytechnique de Bordeaux-Centre National de la Recherche Scientifique (CNRS), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO)
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Adult ,Pediatrics ,medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,Population ,030204 cardiovascular system & hematology ,White People ,Fibrin Fibrinogen Degradation Products ,03 medical and health sciences ,0302 clinical medicine ,[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system ,Risk Factors ,medicine ,Clinical endpoint ,Humans ,Prospective Studies ,030212 general & internal medicine ,education ,Prospective cohort study ,False Negative Reactions ,Case report form ,ComputingMilieux_MISCELLANEOUS ,Aged ,Ultrasonography ,education.field_of_study ,Intention-to-treat analysis ,business.industry ,Angiography ,Anticoagulants ,Hematology ,Emergency department ,Middle Aged ,medicine.disease ,3. Good health ,Pulmonary embolism ,Treatment Outcome ,Observational study ,Emergency Service, Hospital ,Pulmonary Embolism ,business ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
Summary 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.
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- 2017
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4. Effects of sildenafil on maximum walking time in patients with arterial claudication: The ARTERIOFIL study
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Valérie Daniel, Yoanna Onillon, Chadi Homedan, Pascal Reynier, Clara Locher, Loukman Omarjee, Juan-Manuel Chao de la Barca, Isabelle Laporte, Pierre Abraham, Jean-Marie Chretien, Manuela Ripoche, Vincent Jaquinandi, Alain Renault, Vincent Azzola, Marc-Antoine Custaud, Cedric Fontaine, Estelle Le Pabic, Céline Barbeau-Terrier, Guillaume Mahé, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier de Redon (CH Redon), Centre Hospitalier de Cholet, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Angers University Hospital, Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), and Jonchère, Laurent
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0301 basic medicine ,Male ,Time Factors ,Physiology ,[SDV]Life Sciences [q-bio] ,Walking ,030204 cardiovascular system & hematology ,chemistry.chemical_compound ,0302 clinical medicine ,Clinical endpoint ,Medicine ,Prospective Studies ,Treadmill ,ComputingMilieux_MISCELLANEOUS ,Cross-Over Studies ,Exercise Tolerance ,Absolute walking time ,Middle Aged ,3. Good health ,Walking time ,[SDV] Life Sciences [q-bio] ,Treatment Outcome ,Anesthesia ,Molecular Medicine ,Exercise oximetry ,Female ,France ,medicine.symptom ,Sildenafil ,Treadmill walking test ,Walk Test ,Placebo ,Sildenafil Citrate ,03 medical and health sciences ,Peripheral Arterial Disease ,Double-Blind Method ,Humans ,Aged ,Pharmacology ,Peripheral artery disease ,business.industry ,Oxygenation ,Recovery of Function ,Intermittent Claudication ,Phosphodiesterase 5 Inhibitors ,respiratory tract diseases ,Clinical trial ,030104 developmental biology ,chemistry ,Claudication ,business ,Biomarkers - Abstract
Patients with lower extremity peripheral artery disease (PAD) frequently experience claudication, a clinical symptom indicative of reduced walking capacity. Recommended care consists of exercise rehabilitation combined with optimal medical treatment and surgery. The effects of a single oral dose of sildenafil, a phosphodiesterase type-5 inhibitor, on patients with claudication are discussed. The aim of this study was to test the efficacy of a single 100 mg dose of sildenafil compared to placebo in terms of maximal walking time (MWT) in patients with claudication.The ARTERIOFIL study is a crossover, double-blind, prospective, randomized, single-center study conducted at Angers University Hospital in France. MWT (primary endpoint) was assessed using a treadmill test (10% incline; 3.2 km/h). Secondary endpoints (pain-free walking time (PFWT), transcutaneous oximetry during exercise and redox cycle parameters and safety) were also studied.Fourteen patients were included of whom two were ultimately excluded. In the 12 remaining patients, the MWT was significantly improved during the sildenafil period compared with the placebo period (300 s [95% CI 172 s-428 s] vs 402 s [95% CI 274 s-529 s] p 0.01). Sildenafil had no significant effect on pain-free walking time or skin tissue oxygenation during exercise. According to redox cycle parameters, sildenafil significantly reduced blood glucose and pyruvate levels and the 3-hydroxybutyrate/acetoacetate ratio, while there was no significant effect on lactate, 3-hydroxybutyrate, acetoacetate and free fatty acid levels. Symptomatic transient hypotension was observed in two women.The ARTERIOFIL study has shown that a single 100 mg oral dose of sildenafil had a significant effect on increase in MWT but had no significant effects on PFWT and oxygenation parameters in patients with claudication. A double-blind, prospective, randomized, multicenter study (VIRTUOSE©) is ongoing to evaluate the chronic effect of six month-long sildenafil treatment on MWT in PAD patients with claudication.This clinical trial was registered at clinicaltrials.gov, registration. number: NCT02832570, (https://clinicaltrials.gov/ct2/show/NCT02832570).
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- 2019
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5. High prevalence of exercise-induced ischemia in the asymptomatic limb of patients with apparently strictly unilateral symptoms and unilateral peripheral artery disease
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Myriam Ammi, Pierre Abraham, Jean-Marie Chretien, Pascal Bauer, Samir Henni, Xavier Papon, Jeanne Hersant, Jean Picquet, Mickael Daligault, Tanguy Le Meliner, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), and Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
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Male ,lcsh:Diseases of the circulatory (Cardiovascular) system ,Time Factors ,Arterial disease ,[SDV]Life Sciences [q-bio] ,Disease ,030204 cardiovascular system & hematology ,0302 clinical medicine ,Prevalence ,Medicine ,Pharmacology (medical) ,Treadmill ,Original Research ,treadmill testing ,High prevalence ,Exercise Tolerance ,exercise ,Middle Aged ,3. Good health ,diabetes mellitus ,Cardiology ,Female ,France ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,Ischemia ,walking impairment ,Asymptomatic ,03 medical and health sciences ,peripheral arterial disease ,Internal medicine ,Diabetes mellitus ,Humans ,Retrospective Studies ,claudication ,business.industry ,transcutaneous oxygen pressure ,Intermittent Claudication ,medicine.disease ,ankle brachial index ,body regions ,Regional Blood Flow ,lcsh:RC666-701 ,Exercise Test ,lower limb ,business ,Claudication ,030217 neurology & neurosurgery ,Follow-Up Studies - Abstract
Background: The prevalence of exercise-induced ischemia in the asymptomatic limb of patients with unilateral claudication based on history and treadmill evaluation, and with unilateral ipsilateral peripheral artery disease (i.e ankle-to-brachial systolic pressure index Methods: We detected exercise-induced ischemia in the asymptomatic limb of patients with apparently unilateral claudication. Among 6059 exercise-oximetry tests performed in 3407 nondiabetic and 961 diabetic patients. We estimated the intensity of ischemia in the both limb (buttocks and calves) using the lowest minimum value of the decrease from rest of oxygen pressure (DROP; limb changes minus chest changes from rest), with significant ischemia defined as DROP lower than −15 mmHg. Results: We found 152 tests performed in 142 nondiabetic patients and 40 tests performed in 38 diabetic patients. The asymptomatic limb showed significant ischemia in 46.7% and 37.5% of the tests. Strictly unilateral exercise-induced claudication with apparently unilateral peripheral artery disease was rare (Conclusion: The asymptomatic limb of patients with peripheral artery disease should not be considered a normal limb.
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- 2019
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6. HIBISCUS: Hydroxychloroquine for the secondary prevention of thrombotic and obstetrical events in primary antiphospholipid syndrome
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Patrick Blanco, Maarten Limper, Jamilya Khizroeva, Pier Luigi Meroni, Olivier Lambotte, Nadine Magy-Bertrand, Loic Sentilhes, Raquel Ferrer-Oliveras, Pieter Van Paasen, Jan Willem Cohen Tervaert, Marie Noelle Ungeheuer, Enrique Esteve-Valverde, Katrien Devreese, Ricard Cervera, Laura Andreoli, A. Djokovic, Emmanuel Andrès, Antonia Caligaro, Jean Sibilia, Daniel Henrion, Angela Tincani, Guillaume Mahé, Jose Omar Latino, N. Stanisavljevic, Sebastián Udry, Patrick Saulnier, Ljudmila Stojanovich, Şule Apraş Bilgen, Bernard Imbert, Cédric Landron, Damien Sène, Karina de Leeuw, Céline Fassot, Fatma Said, Boris Bienvenu, Laura Damian, Florence Perrinet, Jaume Alijotas-Reig, Francesca Pregnolato, Alban Godon, Estibaliz Lazaro, Thierry Martin, Viktoria Bitsadze, Laurent Arnaud, Laurent Loufrani, Gilles Pernod, Alexander Makatsariya, Gilberto Pires da Rosa, Noémie Jourde-Chiche, Pierre Yves Jeandel, Elisabeta Candrea, Maria Orietta Borghi, Milena Hasan, Jean Marie Chretien, Crina Sinescu, Cristina Belizna, Mathilde Versini, Pascale Jeannin, Thomas Le Gallou, Fréderic Tollis, Marc Antoine Pistorius, Loukman Omarjee, Valentina Canti, Mohamed Hamidou, Achile Aouba, György Nagy, Ova Shovman, Sébastien Abad, Levent Kilic, Teresa Delross, Howard Amital, Lai-Shan Tam, Zahir Amoura, Christian Muchardt, Amelia Ruffatti, Laurent Chiche, Patrick Jego, Emmanuelle Dernis, Maria Favaro, Miri Blank, Romain Lubin, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Biologie Neurovasculaire et Mitochondriale Intégrée (BNMI), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Université Paris 13 (UP13), Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Vall d'Hebron University Hospital [Barcelona], Sackler Faculty of Medicine, Tel Aviv University (TAU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), University of Brescia, CHU Strasbourg, Université de Caen Normandie (UNICAEN), Normandie Université (NU), Hacettepe University = Hacettepe Üniversitesi, Hôpital Saint-Joseph [Marseille], Department of Obstetrics and Gynecology, I.M. Sechenow First Moscow State Medical University, Moscow, Russia., Immunology from Concept and Experiments to Translation (ImmunoConcept), Université de Bordeaux (UB)-Centre National de la Recherche Scientifique (CNRS), Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Università degli Studi di Padova = University of Padua (Unipd), University of Medicine and Pharmacy, Luliu-Hatieganu, Hôpital Européen [Fondation Ambroise Paré - Marseille], Maastricht University [Maastricht], University of Alberta, Universitatea Babeş-Bolyai [Cluj-Napoca], Centre Hospitalier du Mans, Ghent University Hospital, University of Belgrade [Belgrade], Althaia Healthcare Network of Manresa, Barcelona, MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Cardiovascular Functions In Vitro (CARFI), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche Translationnelle - Center for Translational Science (CRT), Institut Pasteur [Paris] (IP), CHU Grenoble, Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA), Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM)-Hôtel-Dieu de Nantes-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Laennec-Centre National de la Recherche Scientifique (CNRS)-Faculté de Médecine d'Angers-Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Pontchaillou [Rennes], Vascular research center of Marseille (VRCM), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Obstetrics and Gynecology, I.M. Sechenow First Moscow State Medical University, Moscow, Immunologie des Maladies Virales et Autoimmunes (IMVA - U1184), Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Hospital Carlos G. Durand, Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], University Medical Center Groningen [Groningen] (UMCG), University Medical Center [Utrecht], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Cellules Souches et Développement / Stem Cells and Development, Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS), Semmelweis University [Budapest], Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Hospital de São João [Porto], Hôpital La Rabta [Tunis], Hôpital Lariboisière, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service de rhumatologie [Strasbourg], CHU Strasbourg-Hôpital de Hautepierre [Strasbourg], Université de Médecine Carol Davila, The Chinese University of Hong Kong [Hong Kong], Diaverum Dialysis Center, Angers, Investigation Clinique et d’Accès aux Ressources Biologiques (Plate-forme) - Clinical Investigation and Access to BioResources (ICAReB), Institut Arnault Tzanck, Barcelona Centre for International Health Research, Hospital Clinic (CRESIB), Universitat de Barcelona (UB), The HIBISCUS study is funded for its French part of the trial by the Ministery of Health, France in 2015 (PHRC N PAPIRUS)., The investigators are very grateful to Professor Y Shoenfeld for the scientific revision of the design and very valuable remarks. The investigators are also grateful to the patients, patients' association, collaborators and networks involved in the trial and to the research staff at all participating hospitals., Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université d'Angers (UA), Hôpital avicenne, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris 13 (UP13)-Hôpital Avicenne, Tel Aviv University [Tel Aviv], Service de médecine interne [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Universita degli Studi di Padova, Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Centre de Recherche Translationnelle (CRT), Institut Pasteur [Paris], Université Nice Sophia Antipolis (... - 2019) (UNS), Université Côte d'Azur (UCA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Centre recherche en CardioVasculaire et Nutrition (C2VN), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Hôpital Jean Minjoz, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Cellules Souches et Développement, Institut Pasteur [Paris]-Centre National de la Recherche Scientifique (CNRS), Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP)-IMAG-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Lariboisière-Université Paris Diderot - Paris 7 (UPD7), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Centre National de la Recherche Scientifique (CNRS)-Université de Bordeaux (UB), Université Paris Diderot - Paris 7 (UPD7)-Hôpital Lariboisière-Fernand-Widal [APHP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
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ANTICOAGULANT ,Pediatrics ,Additional Therapy ,[SDV]Life Sciences [q-bio] ,030204 cardiovascular system & hematology ,RECOMMENDATIONS ,COMPLEMENT ,0302 clinical medicine ,Pregnancy ,An international multicenter trial on Hydroxychloroquine for the secondary prevention of relapses in primary antiphospholipid syndrome is launched ,Antiphospholipid syndrome ,Immunology and Allergy ,PREGNANT PATIENTS ,SYSTEMIC-LUPUS-ERYTHEMATOSUS ,Secondary prevention ,Anticoagulant ,Pregnancy Outcome ,Take home messages ,WOMEN ,3. Good health ,[SDV.IMM]Life Sciences [q-bio]/Immunology ,Female ,medicine.drug ,Hydroxychloroquine ,Primary antiphospholipid syndrome ,medicine.medical_specialty ,medicine.drug_class ,Immunology ,Relapse rate ,Relapse rate in antiphospholipid syndrome (APS) is high despite standard current therapies ,53 centers from 16 countries participate to this international trial ,Orphan drug ,03 medical and health sciences ,Survival rate in this population is 90.1% at 10 years and 65% at 15 years ,There is a need for additional or alternative therapies in this disease ,hydroxychloroquine ,primary antiphospholipid syndrome ,secondary prevention ,medicine ,MANAGEMENT ,Humans ,DRUGS ,030203 arthritis & rheumatology ,business.industry ,Thrombosis ,Delivery, Obstetric ,medicine.disease ,ANTIBODIES ,RISK-FACTORS ,business - Abstract
International audience; The relapse rate in antiphospholipid syndrome (APS) remains high, i.e. around 20%–21% at 5 years in thrombotic APS and 20–28% in obstetrical APS [2, 3].Hydroxychloroquine (HCQ) appears as an additional therapy, as it possesses immunomodulatory and anti-thrombotic various effects [4–16].Our group recently obtained the orphan designation of HCQ in antiphospholipid syndrome by the European Medicine Agency.Furthermore, the leaders of the project made the proposal of an international project, HIBISCUS, about the use of Hydroxychloroquine in secondary prevention of obstetrical and thrombotic events in primary APS. This study has been launched in several countries and at now, 53 centers from 16 countries participate to this international trial.This trial consists in two parts: a retrospective and a prospective study.The French part of the trial in thrombosis has been granted by the French Minister of Health in December 2015 (the academic trial independent of the pharmaceutical industry PHRC N PAPIRUS) and is coordinated by one of the members of the leading consortium of HIBISCUS.
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- 2018
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7. Primary antiphospholipid syndrome and antiphospholipid syndrome associated to systemic lupus: Are they different entities?
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Pier Luigi Meroni, Laura Damian, Cristina Belizna, Daniel Henrion, Ljudmila Stojanovich, Laurent Loufrani, Patrick Saulnier, Guillaume Mahé, Pascal Reynier, Enrique Esteve-Valverde, Jan Willem Cohen-Tervaert, Milena Hasan, Jaume Alijotas-Reig, Ferdinando Nicoletti, Alban Godon, Laurent Arnaud, Katrien Devreese, Marie Noelle Ungeheuer, György Nagy, Loukman Omarjee, Céline Fassot, Marc Antoine Pistorius, Jean Marie Chretien, Christian Muchardt, Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA), Biologie Neurovasculaire et Mitochondriale Intégrée (BNMI), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), University of Belgrade [Belgrade], Maastricht University [Maastricht], Biologie Neurovasculaire Intégrée (BNVI), Semmelweis University [Budapest], Régulation épigénétique - Epigenetic regulation, Institut Pasteur [Paris]-Centre National de la Recherche Scientifique (CNRS), Cytometrie et Biomarqueurs – Cytometry and Biomarkers (UTechS CB), Institut Pasteur [Paris], Investigation Clinique et d’Accès aux Ressources Biologiques (Plate-forme) - Clinical Investigation and Access to BioResources (ICAReB), CHU Strasbourg, Universitat Autònoma de Barcelona (UAB), University of Catania [Italy], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre hospitalier universitaire de Nantes (CHU Nantes), Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Ghent University Hospital, MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS), Institut Pasteur [Paris] (IP), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Primary antiphospholipid syndrome ,Some limitation ,ERYTHEMATOSUS ,Immunology ,030204 cardiovascular system & hematology ,Bioinformatics ,03 medical and health sciences ,0302 clinical medicine ,Antiphospholipid syndrome ,CARDIAC MANIFESTATIONS ,Immunology and Allergy ,Medicine ,Humans ,Lupus Erythematosus, Systemic ,In patient ,CLASSIFICATION CRITERIA ,Secondary antiphospholipid syndrome ,ANTIBODY TYPE ,030203 arthritis & rheumatology ,Systemic lupus erythematosus ,ANTICOAGULANT ACTIVITY ,business.industry ,Systemic lupus ,SECONDARY ,Genetic data ,medicine.disease ,3. Good health ,THROMBOGENIC MECHANISM ,ANNEXIN A5 ,[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,CARDIOVASCULAR-DISEASE ,SYNDROME APS ,Antibodies, Antiphospholipid ,[SDV.IMM]Life Sciences [q-bio]/Immunology ,Identification (biology) ,business - Abstract
International audience; Primary antiphospholipid syndrome (PAPS) and antiphospholipid syndrome associated to lupus (SAPS) have several overlapping characteristics. As systemic manifestations are also reported in patients with PAPS, and as a subgroup of PAPS patients could evaluate to a SAPS, the differentiation between the two types of APS could be performed based on the clinical experience of the medical teams and is related to a variety of clinical, biological, histological and genetic features. Several data are available in the literature with respect to the identification of distinctive features between these two entities. However, there are some limitation in the interpretation of results issued from studies performed prior to updated Sydney criteria. Based on recent data, a certain number of features more frequent in one type of APS as compared to the other could be distinguished. The major differentiation between these two entities is genetical. New genetic data allowing the identification of specific subgroups of APS are ongoing.
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- 2018
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8. Sedative premedication before surgery – A multicentre randomized study versus placebo
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Christophe Aveline, Jacques Bruna, Valérie Daniel, Ngai Liu, Jean-Marc Malinovsky, Laurent Beydon, Adrien Rouxel, Denis Dupoiron, Corinne Alberti, Naren Schinkel, Adriana Bildea, Astrid Darsonval, Laetitia Rault, Nicolas Camut, Emmanuel Marret, and Jean-Marie Chretien
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,medicine.drug_class ,Visual analogue scale ,Anxiety ,Critical Care and Intensive Care Medicine ,Placebo ,Anxiolytic ,Piperazines ,law.invention ,Young Adult ,Double-Blind Method ,Randomized controlled trial ,law ,medicine ,Humans ,Hypnotics and Sedatives ,Aged ,Alprazolam ,business.industry ,Fear ,General Medicine ,Middle Aged ,Surgery ,Affect ,Anesthesiology and Pain Medicine ,Anti-Anxiety Agents ,Anesthesia ,Sedative ,Female ,Premedication ,France ,medicine.symptom ,business ,Azabicyclo Compounds ,Preanesthetic Medication ,medicine.drug - Abstract
Anxiolytic premedication before non-ambulatory surgery in adult patients may have become of less importance in an era of better preoperative patient information. Moreover, an oral hypnotic given the night before surgery may be as efficient as an anxiolytic for relieving patient anxiety. These two strategies were compared for superiority to a placebo and to each other for non-inferiority.Double-blind, randomized, multicentre study versus placebo. Eight hospitals in France. June 2011 to February 2013.Non-ambulatory consecutive surgical patients undergoing general surgery.Patients received either zopiclone 7.5mg the night before surgery (n=204), or alprazolam 0.5mg the morning of surgery (n=206) and controls received placebo (n=68). Demographic data, preoperative anxiety, fear of surgery and anaesthesia, and mood were assessed the day before surgery using a visual analogue scale, the Spielberger scale and the APAIS scale. In the operating room, anxiety and comfort were assessed in addition to physiological data.Preoperative data did not differ between groups. In the operating room, anxiety and comfort were moderate and did not differ significantly between groups on a 1-10 scale (median [25-75 percentile]): zopiclone: 2 [1-4] and 2.5 [1-5]; alprazolam: 2 [1,4] and 2 [1-5]; placebo: 3 [1-5] and 3 [1-5]. The patients who were more anxious preoperatively remained so in the operating room, irrespective of the treatment received (r=0.31, p0.001). A placebo effect was observed in 38% of patients in the corresponding group. Patients receiving zopiclone reported a significantly better sleep the night before surgery compared to other groups (median: 2 vs. 1, p0.001).Premedication in non-ambulatory surgery is no more effective than a placebo, owing to the very moderate level of anxiety experienced by patients.
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- 2015
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9. Ten (not so) simple rules for clinical trial data-sharing
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Claude Pellen, Anne Le Louarn, Gilliosa Spurrier-Bernard, Evelyne Decullier, Jean-Marie Chrétien, Eric Rosenthal, Gérard Le Goff, David Moher, John P. A. Ioannidis, and Florian Naudet
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Biology (General) ,QH301-705.5 - Abstract
Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing: Rule 1: Abide by local legal and regulatory data protection requirements Rule 2: Anticipate the possibility of clinical trial data-sharing before obtaining funding Rule 3: Declare your intent to share data in the registration step Rule 4: Involve research participants Rule 5: Determine the method of data access Rule 6: Remember there are several other elements to share Rule 7: Do not proceed alone Rule 8: Deploy optimal data management to ensure that the data shared is useful Rule 9: Minimize risks Rule 10: Strive for excellence.
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- 2023
10. Assessment of water enema computed tomography: an effective imaging technique for the diagnosis of colon cancer: Colon cancer: computed tomography using a water enema
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Denis Heresbach, Christophe Aubé, Jean-Marie Chretien, Dominique Luet, Patrick Pessaux, François Bailly, Christophe Beziat, Bruno Vielle, Pierre-Jean Valette, Yves Gandon, Jérôme Lebigot, Mickaël Bismuth, Franck Carbonnel, Jérôme Dumortier, Franck Pilleul, Marjolaine DeBilly, Catherine Ridereau-Zins, Marie Ange Pierredon-Foulongne, Centre de Recherche et d'Application en Traitement de l'Image et du Signal (CREATIS), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-École Supérieure Chimie Physique Électronique de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département d'hépatologie, Hospices Civils de Lyon (HCL), Service de radiologie et imagerie médicale [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Department of Gastroenterology, Centre Hospitalier Universitaire [Rennes], STMicroelectronics [Crolles] (ST-CROLLES), Agents pathogènes et inflammation - UFC (EA 4266) (API), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Chimie Et Interdisciplinarité : Synthèse, Analyse, Modélisation (CEISAM), Centre National de la Recherche Scientifique (CNRS)-Université de Nantes - UFR des Sciences et des Techniques (UN UFR ST), Université de Nantes (UN)-Université de Nantes (UN), Centre de Chirurgie Viscérale et de Transplantation - Hôpital de Hautepierre, Service d'hépato-gastro-entérologie [Rennes] = Gastroenterology [Rennes], CHU Pontchaillou [Rennes], Service d'hépatologie, Hôpital Hôtel Dieu, Départment de Statistiques Bio-médicales, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes], Université de Nantes - UFR des Sciences et des Techniques (UN UFR ST), Université de Nantes (UN)-Université de Nantes (UN)-Centre National de la Recherche Scientifique (CNRS)-Institut de Chimie du CNRS (INC), Service d'hépato-gastro-entérologie [Rennes], and Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-École Supérieure Chimie Physique Électronique de Lyon-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Male ,Colorectal cancer ,[SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging ,medicine.medical_treatment ,Contrast Media ,Computed tomography ,Gastroenterology ,030218 nuclear medicine & medical imaging ,0302 clinical medicine ,[INFO.INFO-TS]Computer Science [cs]/Signal and Image Processing ,Colonic disease ,ComputingMilieux_MISCELLANEOUS ,Incidental Findings ,Radiological and Ultrasound Technology ,medicine.diagnostic_test ,Colonoscopy ,General Medicine ,Enema ,[PHYS.MECA.ACOU]Physics [physics]/Mechanics [physics]/Acoustics [physics.class-ph] ,3. Good health ,[SPI.ELEC]Engineering Sciences [physics]/Electromagnetism ,surgical procedures, operative ,030220 oncology & carcinogenesis ,[INFO.INFO-TI]Computer Science [cs]/Image Processing [eess.IV] ,Colonic Neoplasms ,[PHYS.PHYS.PHYS-MED-PH]Physics [physics]/Physics [physics]/Medical Physics [physics.med-ph] ,Female ,[SDV.IB]Life Sciences [q-bio]/Bioengineering ,Radiology ,Imaging technique ,[SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing ,medicine.medical_specialty ,Colon ,Urology ,Sensitivity and Specificity ,digestive system ,03 medical and health sciences ,Predictive Value of Tests ,Internal medicine ,medicine ,[INFO.INFO-IM]Computer Science [cs]/Medical Imaging ,Humans ,Radiology, Nuclear Medicine and imaging ,Aged ,[SPI.ACOU]Engineering Sciences [physics]/Acoustics [physics.class-ph] ,business.industry ,Water ,Cancer ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,Hepatology ,medicine.disease ,digestive system diseases ,[SPI.OPTI]Engineering Sciences [physics]/Optics / Photonic ,Tomography, X-Ray Computed ,business ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
International audience; AIM: The aim of this study was to assess the accuracy of water enema computed tomography (WECT) for the diagnosis of colon cancer. METHODS: A total of 191 patients referred for clinically suspected colon cancer were prospectively evaluated by WECT in a multicenter trial. Examination was contrast enhanced helical CT after colon filling through a rectal tube. For all the cases, final diagnosis was obtained by colonoscopy and/or surgery. CT data were interpreted both locally and at a centralized site by a specialized and general radiologist. RESULTS: Seventy-one patients were diagnosed with colon cancer. Overall, WECT sensitivity and specificity were 98.6 and 95.0%, respectively. Positive and negative predictive values were 92.1 and 99.1%, respectively. In a subgroup of 33 patients with unclean bowel, the sensitivity and specificity of WECT were 95.0 and 92.3%, respectively. The correlation between local radiologists and the specialized radiologist was excellent (Kappa = 0.87) as was the correlation between the general radiologist and the specialist (Kappa = 0.92). CONCLUSION: This prospective analysis demonstrates that WECT is an effective, safe, and simple imaging technique for the diagnosis of colon cancer and can be proposed when a strong clinical suspicion of colon cancer is present, especially in frail patients.
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- 2010
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11. A computerized handheld decision-support system to improve pulmonary embolism diagnosis: a randomized trial
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Arnaud Perrier, Aurore Armand-Perroux, Ludovic Martino, Jean-Marie Chretien, Mohamed Hachelaf, Pierre-Marie Roy, Alain-Eric Dubart, Guy Meyer, Florence Gillaizeau, Pierre Durieux, Catherine Legall, Mirko Cristiano, Jeannot Schmidt, Cardioprotection, Remodelage et Thrombose (CRT), and Université d'Angers (UA)
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Male ,Pediatrics ,medicine.medical_specialty ,Randomization ,[SDV]Life Sciences [q-bio] ,030204 cardiovascular system & hematology ,law.invention ,Pulmonary Embolism/*diagnosis ,03 medical and health sciences ,Outcome Assessment (Health Care) ,0302 clinical medicine ,Randomized controlled trial ,law ,Outcome Assessment, Health Care ,Internal Medicine ,medicine ,Humans ,030212 general & internal medicine ,Cluster randomised controlled trial ,Prospective Studies ,Prospective cohort study ,ddc:616 ,Likelihood Functions ,business.industry ,General Medicine ,Guideline ,Emergency department ,Middle Aged ,medicine.disease ,Decision Support Systems, Clinical ,Emergency Service, Hospital/*standards ,3. Good health ,Pulmonary embolism ,Clinical trial ,Computers, Handheld ,Emergency medicine ,Practice Guidelines as Topic ,Female ,Guideline Adherence ,business ,Emergency Service, Hospital ,Pulmonary Embolism ,Follow-Up Studies - Abstract
International audience; Background: Testing for pulmonary embolism often differs from that recommended by evidence-based guidelines.Objective: To assess the effectiveness of a handheld clinical decision-support system to improve the diagnostic work-up of suspected pulmonary embolism among patients in the emergency department. Design: Cluster randomized trial. Assignment was by random-number table, providers were not blinded, and outcome assessment was automated. (ClinicalTrials.gov registration number: NCT00188032) Setting: 20 emergency departments in France. Patients: 1103 and 1768 consecutive outpatients with suspected pulmonary embolism. Intervention: After a preintervention period involving 20 centers and 1103 patients, in which providers grew accustomed to inputting clinical data into handheld devices and investigators assessed baseline testing, emergency departments were randomly assigned to activation of a decision-support system on the devices (10 centers, 753 patients) or posters and pocket cards that showed validated diagnostic strategies (10 centers, 1015 patients). Measurements: Appropriateness of diagnostic work-up, defined as any sequence of tests that yielded a posttest probability less than 5% or greater than 85% (primary outcome) or as strict adherence to guideline recommendations (secondary outcome); number of tests per patient (secondary outcome). Results: The proportion of patients who received appropriate diagnostic work-ups was greater during the trial than in the preintervention period in both groups, but the increase was greater in the computer-based guidelines group (adjusted mean difference in increase, 19.3 percentage points favoring computer-based guidelines [95% CI, 2.9 to 35.6 percentage points]; PÂ= 0.023). Among patients with appropriate work-ups, those in the computer-based guidelines group received slightly fewer tests than did patients in the paper guidelines group (mean tests per patient, 1.76 [SD, 0.98] vs. 2.25 [SD, 1.04]; PÂ< 0.001). Limitation: The study was not designed to show a difference in the clinical outcomes of patients during follow-up. Conclusion: A handheld decision-support system improved diagnostic decision making for patients with suspected pulmonary embolism in the emergency department.Primary Funding Source: French National Hospital Clinical Research Project.
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- 2009
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12. Cardiopulmonary bypass and internal thoracic artery: Can roller or centrifugal pumps change vascular reactivity of the graft? The IPITA study: A randomized controlled clinical trial.
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Olivier Fouquet, Simon Dang Van, Anna Baudry, Philippe Meisnerowski, Pauline Robert, Frédéric Pinaud, Patrice Binuani, Jean-Marie Chrétien, Daniel Henrion, Christophe Baufreton, and Laurent Loufrani
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Medicine ,Science - Abstract
BackgroundCardiopulmonary bypass (CPB) induces a systemic inflammatory response (SIRS) and affects the organ vascular bed. Experimentally, the lack of pulsatility alters myogenic tone of resistance arteries and increases the parietal inflammatory response. The purpose of this study was to compare the vascular reactivity of the internal thoracic arteries (ITAs) due to the inflammatory response between patients undergoing coronary artery bypass grafting (CABG) under CPB with a roller pump or with a centrifugal pump.MethodsEighty elective male patients undergoing CABG were selected using one or two internal thoracic arteries under CPB with a roller pump (RP group) or centrifugal pump (CFP group). ITA samples were collected before starting CPB (Time 1) and before the last coronary anastomosis during aortic cross clamping (Time 2). The primary endpoint was the endothelium-dependent relaxation of ITAs investigated using wire-myography. The secondary endpoint was the parietal inflammatory response of arteries defined by the measurements of superoxide levels, leukocytes and lymphocytes rate and gene expression of inflammatory proteins using. Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.ResultsExposure time of ITAs to the pump flow was respectively 43.3 minutes in the RP group and 45.7 minutes in the CFP group. Acetylcholine-dependent relaxation was conserved in the two groups whatever the time. Gene expression of C3 and C4a in the artery wall decreased from Time 1 to Time 2. No oxidative stress was observed in the graft. There was no difference between the groups concerning the leukocytes and lymphocytes rate. SC5b-9 and elastase increased between Time 1 and Time 2.ConclusionEndothelium-dependent relaxation of the internal thoracic arteries was preserved during CPB whatever the type of pump used. The inflammatory response observed in the blood was not found in the graft wall within this time frame.Trial registrationName of trial study protocol: IPITA Registration number (ClinicalTrials.gov): NCT04168853.
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- 2020
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13. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial.
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Pierre-Marie Roy, Antoine Rachas, Guy Meyer, Grégoire Le Gal, Pierre Durieux, Dominique El Kouri, Didier Honnart, Jeannot Schmidt, Catherine Legall, Pierre Hausfater, Jean-Marie Chrétien, Dominique Mottier, and PREVENU study group
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Medicine ,Science - Abstract
BACKGROUND:Misuse of thromboprophylaxis may increase preventable complications for hospitalized medical patients. OBJECTIVES:To assess the net clinical benefit of a multifaceted intervention in emergency wards (educational lectures, posters, pocket cards, computerized clinical decision support systems and, where feasible, electronic reminders) for the prevention of venous thromboembolism. PATIENTS/METHODS:Prospective cluster-randomized trial in 27 hospitals. After a pre-intervention period, centers were randomized as either intervention (n = 13) or control (n = 14). All patients over 40 years old, admitted to the emergency room, and hospitalized in a medical ward were included, totaling 1,402 (712 intervention and 690 control) and 15,351 (8,359 intervention and 6,992 control) in the pre-intervention and intervention periods, respectively. RESULTS:Symptomatic venous thromboembolism or major bleeding (primary outcome) occurred at 3 months in 3.1% and 3.2% of patients in the intervention and control groups, respectively (adjusted odds ratio: 1.02 [95% confidence interval: 0.78-1.34]). The rates of thromboembolism (1.9% vs. 1.9%), major bleedings (1.2% vs. 1.3%), and mortality (11.3% vs. 11.1%) did not differ between the groups. Between the pre-intervention and intervention periods, the proportion of patients who received prophylactic anticoagulant treatment more steeply increased in the intervention group (from 35.0% to 48.2%: +13.2%) than the control (40.7% to 44.1%: +3.4%), while the rate of adequate thromboprophylaxis remained stable in both groups (52.4% to 50.9%: -1.5%; 49.1% to 48.8%: -0.3%). CONCLUSIONS:Our intervention neither improved adequate prophylaxis nor reduced the rates of clinical events. New strategies are required to improve thromboembolism prevention for hospitalized medical patients. TRIAL REGISTRATION:ClinicalTrials.gov NCT01212393.
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- 2016
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