Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial.
Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial.
复制标题
术前静脉补铁治疗腹部大手术前贫血（PREVENTT）：一项随机、双盲、对照试验
DOI：
10.1016/s0140-6736(20)31539-7
复制
发表时间：
2020-10-24
期刊：
影响因子：
--
通讯作者：
Klein A
中科院分区：
文献类型：
--
作者：
Richards T;Baikady RR;Clevenger B;Butcher A;Abeysiri S;Chau M;Macdougall IC;Murphy G;Swinson R;Collier T;Van Dyck L;Browne J;Bradbury A;Dodd M;Evans R;Brealey D;Anker SD;Klein A
术前贫血影响大比例的择期手术患者，并与不良结局相关。我们的目的是检验一个假设，即在腹部大手术前给予贫血患者静脉铁剂可以纠正贫血，减少输血需求，改善患者预后。在一项双盲、平行组随机试验中，我们招募了46家英国三级护理中心的成人参与者，这些参与者在择期腹部大手术前接受术前医院访视时被确定患有贫血。贫血定义为男性血红蛋白低于130 g/L，女性低于120 g/L。我们通过一个安全的基于网络的服务随机分配参与者（1：1），在手术前10-42天接受静脉注射铁或安慰剂。静脉铁剂为单剂量1000 mg羧基麦芽糖铁溶于100 mL生理盐水中，安慰剂为100 mL生理盐水，均在15 min内输注。非盲研究人员准备并给予研究药物;参与者和其他临床和研究人员对治疗分配设盲。共同主要终点是输血或死亡的复合结局风险，以及从随机化到术后30天的输血次数。主要分析包括所有随机分配且主要终点数据可用的患者;安全性分析包括根据接受的治疗随机分配的所有患者。本研究已注册，ISRCTN 67322816，并对新参与者关闭。在2014年1月6日至2018年9月28日期间随机分配到安慰剂（n= 243）或静脉铁剂（n=244）的487名参与者中，474名（97%）个体的主要终点的完整数据可用。安慰剂组237例患者中有67例（28%）发生死亡或输血，静脉铁剂组237例患者中有69例（29%）发生死亡或输血（风险比1.03，95%CI 0.78 - 1.37; p= 0.84）。安慰剂组有111例输血，静脉铁剂组有105例输血（率比0.98，95%CI 0.68 - 1.43; p= 0.93）。两组之间的任何预先规定的安全性终点均无显著差异。对于择期腹部大手术前10-42天贫血患者，术前静脉补铁在减少输血需求方面并不上级于安慰剂。英国国家卫生研究院卫生技术评估计划。
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. 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. 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. 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. UK National Institute of Health Research Health Technology Assessment Program.