Study protocol for a multicentre, 2×2 factorial, randomised, controlled trial evaluating the interest of intravenous iron and tranexamic acid to reduce blood transfusion in hip fracture patients (the HiFIT study)

• Published in: BMJ open Vol. 11; no. 1; p. e040273
• Main Authors: Lasocki, Sigismond, Loupec, Thibault, Parot-Schinkel, Elsa, Vielle, Bruno, Danguy des Déserts, Marc, Roquilly, Antoine, Lahlou-Casulli, Maria, Collange, Vincent, Desebbe, Olivier, Duchalais, Alexis, Drugeon, Bertrand, Bouzat, Pierre, Garrigue, Delphine, Mounet, Benjamin, Hamard, Franck, David, Jean-Stéphane, Leger, Maxime, Rineau, Emmanuel, Bouhours, Guillaume, Lebail, Adeline, Samson, Emmanuel, Capdevilla, Xavier, Swisser, Fabien, Deserts, Marc Danguy Des, Asehnoune, Karim, Beloeil, Hélène, Parent, Sébastien, Mimoz, Olivier, Gavazzi, Gaetan, Bijok, Benjamin
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 17-01-2021; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Acids; Activities of daily living; Administration, Intravenous; anaemia; Anemia; Anemia - drug therapy; Antifibrinolytic Agents; Antifibrinolytic Agents - therapeutic use; bleeding disorders & coagulopathies; Blood; blood bank & transfusion medicine; Blood Loss, Surgical; Blood Loss, Surgical - prevention & control; Blood Transfusion; Blood Transfusion - statistics & numerical data; Blood transfusions; Bone marrow; Clinical practice guidelines; Clinical Trials, Phase III as Topic; COVID-19; Double-Blind Method; Ethics; Fractures; France; Gerontology; Haematology (incl blood transfusion); Hemoglobin; Hemoglobins; Hemoglobins - analysis; hip; Hip Fractures; Hip Fractures - complications; Hip Fractures - surgery; Hospitals; Human health and pathology; Humans; Iron; Iron - therapeutic use; Life Sciences; Mortality; Multicenter Studies as Topic; Patients; Pharmaceutical sciences; Pharmacology; Placebo effect; Population; Preoperative Care; Preoperative Care - methods; Randomized Controlled Trials as Topic; Rehabilitation; Santé publique et épidémiologie; Surgery; Tranexamic Acid; Tranexamic Acid - therapeutic use; Treatment Outcome; France; anaemia; blood bank & transfusion medicine; hip; bleeding disorders & coagulopathies
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2020-040273

IntroductionBlood transfusion and anaemia are frequent and are associated with poor outcomes in patients with hip fracture (HF). We hypothesised that preoperative intravenous iron and tranexamic acid (TXA) may reduce the transfusion rate in these patients.Methods and analysisThe HiFIT study is a multicentre, 2×2 factorial, randomised, double-blinded, controlled trial evaluating the effect of iron isomaltoside (IIM) (20 mg/kg) vs placebo and of TXA (intravenously at inclusion and topically during surgery) versus placebo on transfusion rate during hospitalisation, in patients undergoing emergency surgery for HF and having a preoperative haemoglobin between 95 and 130 g/L. 780 patients are expected. The primary endpoint is the proportion of patients receiving an allogenic blood transfusion of packed red blood cells from the day of surgery until hospital discharge (or until D30 if patient is still hospitalised). Enrolment started on March 2017 in 11 French hospitals. The study was stopped between July 2017 and August 2018 (because of investigation of serious AEs with IIM in Spain) and slowed down since March 2020 (COVID-19 crisis). The expected date of final follow-up is May 2022. Analyses of the intent-to-treat and per-protocol populations are planned.Ethics and disseminationThe HiFIT trial protocol has been approved by the Ethics Committee of Comité de Protection des Personnes Ouest II and the French authorities (ANSM). It will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. The HiFIT trial will be the largest study evaluating iron and TXA in patients with HF.Trial registration numberclinicalTrials.gov identifier: NCT02972294; EudraCT Number 2016-003087-40.