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Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial.
Lasocki, Sigismond; Capdevila, Xavier; Vielle, Bruno; Bijok, Benjamin; Lahlou-Casulli, Maria; Collange, Vincent; Grillot, Nicolas; Danguy des Deserts, Marc; Duchalais, Alexis; Delannoy, Bertrand; Drugeon, Bertrand; Bouzat, Pierre; David, Jean-Stéphane; Rony, Louis; Loupec, Thibault; Léger, Maxime; Rineau, Emmanuel.
Afiliação
  • Lasocki S; Département Anesthésie-Réanimation, Pôle Anesthésie Samu Urgences Réanimation, Centre Hospitalier Universitaire d'Angers, Angers, France. Electronic address: sigismond@lasocki.com.
  • Capdevila X; Department of Anesthesiology and Intensive Care Medicine, Lapeyronie University Hospital, Montpellier, France.
  • Vielle B; Département de Biostatistiques, Centre Hospitalier Universitaire d'Angers, Angers, France.
  • Bijok B; Centre Hospitalier Universitaire de Lille, Pôle d'anesthésie-réanimation, Lille, France.
  • Lahlou-Casulli M; Department of Anesthesiology, Critical Care Medicine and Perioperative Medicine, Rennes University Hospital and School of Medicine, Centre Hospitalier Universitaire de Rennes, Rennes, France.
  • Collange V; Department of Anesthesiology, Médipole Lyon Villeurbanne, Lyon, France.
  • Grillot N; Nantes Université, Centre Hospitalier Universitaire de Nantes, Service d'Anesthésie Réanimation Chirurgicale, Immunologie et Infectiologie, Nantes, France.
  • Danguy des Deserts M; Pôle Bloc Anesthésie Réanimation Urgences, Hôpital d'Instruction des Armées Clermont-Tonnerre, INSERM, Université de Bretagne Occidentale, Brest, France.
  • Duchalais A; Centre Hospitalier Départemental Vendée, La Roche sur Yon, France.
  • Delannoy B; Department of Anesthesiology and Intensive Care Medicine, Ramsay Sante, Sauvegarde Clinic, Lyon, France.
  • Drugeon B; Service des Urgences-SAMU-SMUR, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
  • Bouzat P; Université Grenoble Alpes, Inserm, Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble Institut Neurosciences, Grenoble, France.
  • David JS; Service d'Anesthésie Réanimation, Groupe Hospitalier Sud, Hospices Civils de Lyon, Pierre Bénite and Research on Healthcare Performance, Inserm, University Claude Bernard Lyon, Lyon, France.
  • Rony L; Département de Chirurgie osseuse, Centre Hospitalier Universitaire d'Angers, Angers, France.
  • Loupec T; Department of Anesthesiology and Intensive Care Medicine, Lapeyronie University Hospital, Montpellier, France.
  • Léger M; Département Anesthésie-Réanimation, Pôle Anesthésie Samu Urgences Réanimation, Centre Hospitalier Universitaire d'Angers, Angers, France.
  • Rineau E; Département Anesthésie-Réanimation, Pôle Anesthésie Samu Urgences Réanimation, Centre Hospitalier Universitaire d'Angers, Angers, France.
Lancet Haematol ; 10(9): e747-e755, 2023 Sep.
Article em En | MEDLINE | ID: mdl-37524101
BACKGROUND: Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery. METHODS: In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants. FINDINGS: Of 413 patients (51-104 years old, median [IQR] 86 [78-91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27-0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50-1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54-1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse event were sepsis, pneumonia, and urinary infection, with similar rates among all groups. INTERPRETATION: In patients hospitalised for hip fracture surgery with a haemoglobin concentration 9·5-13·0 g/dL, preoperative infusion of ferric derisomaltose plus tranexamic acid reduced the risk of blood transfusion by 50%. Our results suggest that combining treatments from two different pillars improves patient blood-management programmes. Either treatment alone did not reduce transfusion rates, but we might not have had the power to detect it. FUNDING: French Ministry of Health, HiFIT trial.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Ácido Tranexâmico / Fraturas do Quadril / Anemia Tipo de estudo: Clinical_trials / Etiology_studies Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Ácido Tranexâmico / Fraturas do Quadril / Anemia Tipo de estudo: Clinical_trials / Etiology_studies Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2023 Tipo de documento: Article