Background Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied. Aims This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB. Methods This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65 years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9–11 g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180. Results From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49 g/dl in the ferric carboxymaltose group vs. 1.56 g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups. Conclusions Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585).

中文翻译：

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羧基麦芽糖铁对老年消化道出血患者血红蛋白反应的疗效：一项随机临床试验

背景 急性胃肠道出血（AGIB）在老年患者中很常见，但在这种情况下铁剂的使用仍有待研究。目的 本研究旨在前瞻性评估羧基麦芽糖铁治疗 AGIB 后老年患者贫血的疗效。方法 这项随机双盲安慰剂对照临床试验在 10 个法国中心进行。符合条件的患者年龄为 65 岁或以上，上消化道或下消化道出血得到控制，血红蛋白水平为 9-11 g/dl。患者以 1:1 的比例随机分配接受 1 次静脉注射羧基麦芽糖铁或 1 次盐水溶液注射。主要终点是第 0 天和第 42 天之间血红蛋白水平的差异。次要终点是第 180 天治疗中出现的不良事件、严重不良事件、再住院和生活质量 (QOL) 的改善。 2013 年 1 月至 2017 年 1 月的结果，共纳入 59 名患者。患者的中位年龄为 81.9 [75.8, 87.3] 岁。第 42 天时，观察到血红蛋白水平显着增加（羧基麦芽糖铁组为 2.49 g/dl，安慰剂组为 1.56 g/dl，P = 0.02）。第 180 天时，根据欧洲癌症研究和治疗组织生活质量问卷核心 30 进行测量，羧基麦芽糖铁组的 QOL 提高了 10.5 分，安慰剂组提高了 8.2 分（P = 0.56）。两组的不良事件和再住院率相似。结论 静脉补铁对于治疗 AGIB 后老年患者的贫血似乎是安全有效的，应被视为标准治疗方法。 ClinicalTrials.gov (NCT01690585)。