Your browser doesn't support javascript.
Comparison of standard prophylactic, intermediate prophylactic and therapeutic anticoagulation in patients with severe COVID-19: protocol for the ANTICOVID multicentre, parallel-group, open-label, randomised controlled trial.
Labbe, Vincent; Contou, Damien; Heming, Nicholas; Megarbane, Bruno; Ait-Oufella, Hafid; Boissier, Florence; Carreira, Serge; Robert, Alexandre; Vivier, Emmanuel; Fejjal, Mohamed; Doyen, Denis; Monchi, Mehran; Preau, Sebastien; Noel-Savina, Elise; Souweine, Bertrand; Zucman, Noémie; Picos, Santiago Alberto; Dres, Martin; Juguet, William; Mariotte, Eric; Timsit, Jean-François; Turpin, Matthieu; Razazi, Keyvan; Gendreau, Ségolène; Baloul, Samia; Voiriot, Guillaume; Fartoukh, Muriel; Audureau, Etienne; Mekontso Dessap, Armand.
  • Labbe V; Service de Médecine Intensive Réanimation, Hôpital Tenon, Département Médico-Universitaire APPROCHES, Assistance Publique-Hôpitaux de Paris (APHP), Sorbonne Université, Paris, France vincent.labbe@aphp.fr.
  • Contou D; Université Paris Est, Groupe de Recherche Clinique GR05 CARMAS, Institut Mondor de recherche biomédicale, INSERM, Créteil, France.
  • Heming N; Service de Réanimation Polyvalente, Centre Hospitalier Victor Dupouy, Argenteuil, France.
  • Megarbane B; Department of Intensive Care, Hôpital Raymond Poincaré, Assistance Publique - Hopitaux de Paris, University Versailles Saint Quentin - University Paris Saclay, Garches, France.
  • Ait-Oufella H; Laboratory of Infection & Inflammation - U1173, School of Medicine Simone Veil, University Versailles Saint Quentin - University Paris Saclay, INSERM, Garches, France.
  • Boissier F; Service de Réanimation Médicale et Toxicologique, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, INSERM UMRS-1144, Université de Paris, Paris, France.
  • Carreira S; Service de Médecine Intensive Réanimation, Hôpital Saint Antoine, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.
  • Robert A; Service de Médecine Intensive Réanimation, Centre Hospitalo-Universitaire de Poitiers, INSERM CIC 1402 (ALIVE group), Université de Poitiers, Poitiers, France.
  • Vivier E; Service d'Anesthésie-Réanimation polyvalente, Hôpital Saint Camille, Bry-sur-Marne, France.
  • Fejjal M; Service de Médecine Intensive Réanimation, Hôpital Simone Veil, Centre Hospitalier de Cannes, Cannes, France.
  • Doyen D; Unité INSERM 1065, Laboratoire C3M, Université Côte d'Azur, Nice, France.
  • Monchi M; Service de Réanimation Polyvalente, Centre Hospitalier Saint Joseph-Saint Luc, Lyon, France.
  • Preau S; Service de Médecine Intensive Réanimation, Centre Hospitalier Léon Binet, Provins, France.
  • Noel-Savina E; Service de Médecine Intensive Réanimation, Hôpital l'Archet 1, Centre Hospitalier Universitaire de Nice, Nice, France.
  • Souweine B; UR2CA Unité de Recherche Clinique Côte d'Azur, Université Côte d'Azur, Nice, France.
  • Zucman N; Département de Médecine intensive, Groupe Hospitalier Sud Ile de France, Melun, France.
  • Picos SA; Service de Réanimation, INSERM, Institut Pasteur de Lille, U1167, Université de Lille, Centre Hospitalo-Universitaire Lille, Lille, France.
  • Dres M; Service de Pneumologie et de soins intensifs Respiratoires, Hôpital Larrey, Toulouse, France.
  • Juguet W; Service de Médecine Intensive Réanimation, Centre Hospitalo-Universitaire Gabriel-Montpied, Clermont-Ferrand, France.
  • Mariotte E; Service de Médecine Intensive Réanimation, Hôpital Louis-Mourier, DMU ESPRIT, Assistance Publique-Hôpitaux de Paris, Colombes, France.
  • Timsit JF; Université de Paris, UFR de médecine Paris Nord, Paris, France.
  • Turpin M; Service de Médecine Intensive Réanimation, Centre Hospitalier La Dracenie De Draguignan, Draguignan, France.
  • Razazi K; Service de Médecine intensive Réanimation, Hôpital Pitie Salpêtrière, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.
  • Gendreau S; Service de Réanimation Médico-Chirurgicale, Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris, Université Sorbonne Paris Nord, Bobigny, France.
  • Baloul S; Service de Médecine Intensive Réanimation, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.
  • Voiriot G; Medical and infectious diseases ICU (MI2), Bichat Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris, IAME, INSERM U1137, Paris, France.
  • Fartoukh M; Service de Médecine Intensive Réanimation, Hôpital Tenon, Département Médico-Universitaire APPROCHES, Assistance Publique-Hôpitaux de Paris (APHP), Sorbonne Université, Paris, France.
  • Audureau E; Université Paris Est, Groupe de Recherche Clinique GR05 CARMAS, Institut Mondor de recherche biomédicale, INSERM, Créteil, France.
  • Mekontso Dessap A; Service de Médecine Intensive Réanimation, Hôpitaux Universitaires Henri Mondor-Albert Chenevier, Département Médico-Universitaire Médecine, Assistance Publique-Hôpitaux de Paris, Créteil, France.
BMJ Open ; 12(4): e059383, 2022 04 26.
Статья в английский | MEDLINE | ID: covidwho-1816767
ABSTRACT

INTRODUCTION:

COVID-19 induces venous, arterial and microvascular thrombosis, involving several pathophysiological processes. In patients with severe COVID-19 without macrovascular thrombosis, escalating into high-dose prophylactic anticoagulation (HD-PA) or therapeutic anticoagulation (TA) could be beneficial in limiting the extension of microvascular thrombosis and forestalling the evolution of lung and multiorgan microcirculatory dysfunction. In the absence of data from randomised trials, clinical practice varies widely. METHODS AND

ANALYSIS:

This is a French multicentre, parallel-group, open-label, randomised controlled superiority trial to compare the efficacy and safety of three anticoagulation strategies in patients with COVID-19. Patients with oxygen-treated COVID-19 showing no pulmonary artery thrombosis on computed tomography with pulmonary angiogram will be randomised to receive either low-dose PA, HD-PA or TA for 14 days. Patients attaining the extremes of weight and those with severe renal failure will not be included. We will recruit 353 patients. Patients will be randomised on a 111 basis, and stratified by centre, use of invasive mechanical ventilation, D-dimer levels and body mass index. The primary endpoint is a hierarchical criterion at day 28 including all-cause mortality, followed by the time to clinical improvement defined as the time from randomisation to an improvement of at least two points on the ordinal clinical scale. Secondary outcomes include thrombotic and major bleeding events at day 28, individual components of the primary endpoint, number of oxygen-free, ventilator-free and vasopressor-free days at day 28, D-dimer and sepsis-induced coagulopathy score at day 7, intensive care unit and hospital stay at day 28 and day 90, and all-cause death and quality of life at day 90. ETHICS AND DISSEMINATION The study has been approved by an ethical committee (Ethics Committee, Ile de France VII, Paris, France; reference 2020-A03531-38). Patients will be included after obtaining their signed informed consent. The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT04808882.
Тема - темы
ключевые слова

Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: COVID-19 Тип исследования: Экспериментальные исследования / Прогностическое исследование / Рандомизированные контролируемые испытания Пределы темы: Люди Язык: английский Журнал: BMJ Open Год: 2022 Тип: Статья Аффилированная страна: Bmjopen-2021-059383

Документы, близкие по теме

MEDLINE

...
LILACS

LIS


Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: COVID-19 Тип исследования: Экспериментальные исследования / Прогностическое исследование / Рандомизированные контролируемые испытания Пределы темы: Люди Язык: английский Журнал: BMJ Open Год: 2022 Тип: Статья Аффилированная страна: Bmjopen-2021-059383