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)
Introduction Blood 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 analysis The HiFIT study is a m...
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2021-01-01
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| author | Bertrand Drugeon Olivier Mimoz Karim Asehnoune Antoine Roquilly Sigismond Lasocki Hélène Beloeil Olivier Desebbe Pierre Bouzat Bruno Vielle Thibault Loupec Elsa Parot-Schinkel Marc Danguy des Déserts Maria Lahlou-Casulli Vincent Collange Alexis Duchalais Delphine Garrigue Benjamin Mounet Franck Hamard Jean-Stéphane David Maxime Leger Emmanuel Rineau Guillaume Bouhours Adeline Lebail Emmanuel Samson Xavier Capdevilla Fabien Swisser Marc Danguy Des Deserts Sébastien Parent Gaetan Gavazzi Benjamin Bijok |
| author_facet | Bertrand Drugeon Olivier Mimoz Karim Asehnoune Antoine Roquilly Sigismond Lasocki Hélène Beloeil Olivier Desebbe Pierre Bouzat Bruno Vielle Thibault Loupec Elsa Parot-Schinkel Marc Danguy des Déserts Maria Lahlou-Casulli Vincent Collange Alexis Duchalais Delphine Garrigue Benjamin Mounet Franck Hamard Jean-Stéphane David Maxime Leger Emmanuel Rineau Guillaume Bouhours Adeline Lebail Emmanuel Samson Xavier Capdevilla Fabien Swisser Marc Danguy Des Deserts Sébastien Parent Gaetan Gavazzi Benjamin Bijok |
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| description | Introduction Blood 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 analysis The 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 dissemination The 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 number clinicalTrials.gov identifier: NCT02972294; EudraCT Number 2016-003087-40. |
| format | Article |
| id | doaj-art-7f329ab5b9a34b229f47ebc009648004 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-7f329ab5b9a34b229f47ebc0096480042024-11-18T12:15:08ZengBMJ Publishing GroupBMJ Open2044-60552021-01-0111110.1136/bmjopen-2020-040273Study 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) 0Bertrand Drugeon1Olivier Mimoz2Karim Asehnoune3Antoine Roquilly4Sigismond Lasocki5Hélène BeloeilOlivier Desebbe6Pierre Bouzat7Bruno Vielle8Thibault Loupec9Elsa Parot-Schinkel10Marc Danguy des Déserts11Maria Lahlou-Casulli12Vincent Collange13Alexis Duchalais14Delphine Garrigue15Benjamin Mounet16Franck Hamard17Jean-Stéphane David18Maxime Leger19Emmanuel Rineau20Guillaume BouhoursAdeline LebailEmmanuel SamsonXavier CapdevillaFabien SwisserMarc Danguy Des DesertsSébastien ParentGaetan GavazziBenjamin Bijok4Association of British NeurologistsEmergency Department and Prehospital Care, Centre Hospitalier Universitaire de Poitiers, Poitiers, FranceEmergency Department, University Hospital Centre, Poitiers, FranceService de Réanimation Chirurgicale, Centre Hospitalier Universitaire de Nantes, Nantes, FranceService dAnesthésie Réanimation, CHU Nantes, Nantes, FranceDépartement Anesthésie Réanimation, Centre Hospitalier Universitaire dAngers, Angers, FranceRamsay Santé, Clinique de la Sauvegarde, Lyon, FranceDépartement dAnesthésie Réanimation, Centre Hospitalier Universitaire de Grenoble, Grenoble, France4 Centre de Recherche Clinique, CHU d’Angers, Angers, FranceService d’anesthésie réanimation A, Université de Montpellier, CHU de Montpellier, Montpellier, FranceDépartement de Biostatistiques et Méthodologie, Centre Hospitalier Universitaire dAngers, Angers, Pays de la Loire, FranceAnaesthesia and Intensive Care Unit, Clermont-Tonnerre Military Hospital, Brest, FranceDépartement dAnesthésie Réanimation, CHU Rennes, Rennes, FranceDépartement Anesthésie-réanimation, Medipôle Lyon-Villeurbanne, Villeurbanne, FranceService d’anesthésie reanimation, CHD Vendée, La Roche-sur-Yon, FrancePôle d’Anesthésie Réanimation, Pôle de l’Urgence, CHRU, Lille, Hauts-de-France, FranceService d’anesthésie réanimation A, Université de Montpellier, CHU de Montpellier, Montpellier, FranceService dAnesthésie Réanimation, Clinique de lAnjou, Angers, FranceService d’anesthésie réanimation, CHU Lyon Sud, Lyon, FranceDépartement Anesthésie Réanimation, Centre Hospitalier Universitaire dAngers, Angers, FranceDépartement Anesthésie Réanimation, Centre Hospitalier Universitaire dAngers, Angers, FranceIntroduction Blood 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 analysis The 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 dissemination The 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 number clinicalTrials.gov identifier: NCT02972294; EudraCT Number 2016-003087-40.https://bmjopen.bmj.com/content/11/1/e040273.full |
| spellingShingle | Bertrand Drugeon Olivier Mimoz Karim Asehnoune Antoine Roquilly Sigismond Lasocki Hélène Beloeil Olivier Desebbe Pierre Bouzat Bruno Vielle Thibault Loupec Elsa Parot-Schinkel Marc Danguy des Déserts Maria Lahlou-Casulli Vincent Collange Alexis Duchalais Delphine Garrigue Benjamin Mounet Franck Hamard Jean-Stéphane David Maxime Leger Emmanuel Rineau Guillaume Bouhours Adeline Lebail Emmanuel Samson Xavier Capdevilla Fabien Swisser Marc Danguy Des Deserts Sébastien Parent Gaetan Gavazzi Benjamin Bijok 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/1/e040273.full |
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