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Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial

Toby Richards, Ravishankar Rao Baikady, Ben Clevenger, et al

Lancet Published:September 04, 2020 DOI:https://doi.org/10.1016/S0140-6736(20)31539-7

Summary 摘要

Background 背景

Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes.

择期大手术患者术前贫血发生率很高，且与不良预后相关。我们希望验证以下假设，即择期开腹大手术前，对贫血患者静脉补铁能够纠正贫血，减少输血需求，改善患者预后。

Methods 方法

In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10–42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants.

这项双盲、平行对照随机试验在英国46个三级医院进行。入选择期开腹大手术前的成年贫血患者。贫血定义为血红蛋白< 130 g/L（男性）或120 g/L（女性）。我们通过网络系统将患者随机分组(1:1)，在术前10-42天分别接受静脉补铁或安慰剂。静脉补铁采用单剂量羧基麦芽糖铁1000 mg溶于100 ml生理盐水，安慰剂为100 ml生理盐水，输注时间15分钟。由未设盲的研究人员负责准备并输注研究药物；患者及其他临床和研究人员对试验分组设盲。联合主要预后终点为复合终点，包括从随机分组到术后30天内接受输血或死亡，以及输注红细胞数量。主要分析纳入所有接受随机分组且主要预后终点数据齐全的患者；安全性分析纳入所有接受随机分组的患者。试验注册号ISRCTN67322816。

Findings 结果

Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78–1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68–1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints.

2014年1月6日至2018年9月28日间，共有487名患者接受随机分组，安慰剂组(n=243)，静脉补铁组(n=244)，474名 (97%) 患者主要预后终点数据齐全。安慰剂组237名患者中 67名 (28%) 及静脉补铁足237名患者中 69名 (29%) 死亡或接受输血(风险比 1·03, 95% CI 0·78–1·37; p=0·84)。安慰剂组输血111次，静脉补铁组输血 105 次 (比例比 0·98, 95% CI 0·68–1·43; p=0·93)。两组间所有预先确定的安全指标均无显著差异。

Interpretation 结论

Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10–42 days before elective major abdominal surgery.

在择期腹部大手术前10-42天，与安慰剂对照相比，对于贫血患者静脉补铁不能减少输血需求。

Funding 资助

UK National Institute of Health Research Health Technology Assessment Program.