Département Anesthésie Réanimation, Centre Hospitalier Universitaire d'Angers, Angers, France
Service d'anesthésie réanimation A, Université de Montpellier, CHU de Montpellier, Montpellier, France.
BMJ Open. 2021 Jan 17;11(1):e040273. doi: 10.1136/bmjopen-2020-040273.
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.
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.
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.
clinicalTrials.gov identifier: NCT02972294; EudraCT Number 2016-003087-40.
输血和贫血在髋部骨折（HF）患者中很常见，且与不良预后相关。我们假设术前静脉内铁剂和氨甲环酸（TXA）可能会降低这些患者的输血率。
HiFIT 研究是一项多中心、2×2 析因、随机、双盲、对照试验，评估了异麦芽糖铁（IIM）（20mg/kg）与安慰剂和 TXA（入院时静脉内给予，手术期间局部给予）与安慰剂对接受急诊手术治疗的 HF 且术前血红蛋白在 95-130g/L 之间的患者在住院期间输血率的影响。预计将纳入 780 例患者。主要终点是从手术日至出院（或如果患者仍住院，则至 D30）期间接受异体输血（浓缩红细胞）的患者比例。该研究于 2017 年 3 月在 11 家法国医院开始入组。该研究于 2017 年 7 月至 2018 年 8 月间暂停（因为在西班牙对 IIM 的严重不良事件进行了调查），自 2020 年 3 月以来进展缓慢（COVID-19 危机）。预计最终随访日期为 2022 年 5 月。计划对意向治疗人群和符合方案人群进行分析。
HiFIT 试验方案已获得 Ouest II 保护委员会和法国当局（ANSM）的伦理委员会批准。它将按照《赫尔辛基宣言》和《良好临床实践指南》的原则进行。结果将通过在科学会议上的报告和同行评议期刊上的发表进行传播。HiFIT 试验将是评估 HF 患者中铁剂和 TXA 的最大规模研究。
ClinicalTrials.gov 标识符：NCT02972294；EudraCT 编号：2016-003087-40。
