O'Loughlin Edmond, Chih HuiJun, Sivalingam Pal, Symons Joel, Godsall Guy, MacLean Beth, Richards Toby
Department of Anaesthesia, Pain and Perioperative Medicine, Fiona Stanley and Fremantle Hospital Group, Perth, Western Australia, Australia.
School of Population Health, Faculty of Health Sciences, Curtin University, Bentley, Perth, Western Australia, Australia.
BJA Open. 2023 Aug 12;7:100222. doi: 10.1016/j.bjao.2023.100222. eCollection 2023 Sep.
Preoperative anaemia is associated with increased use of blood transfusions, a greater risk of postoperative complications, and patient morbidity. The IRON NOF trial aimed to investigate whether the administration of i.v. iron in anaemic patients during hip fracture surgery reduced the need for blood transfusion and improved patient outcomes.
This phase III double-blind, randomised, placebo-controlled trial included patients >60 yr old with preoperative anaemia undergoing surgery for femoral neck or subtrochanteric fracture across seven Australian Hospitals. Patients were randomly allocated on a 1:1 basis to receive either i.v. iron carboxymaltose 1000 mg or placebo (saline) at operation. The primary endpoint was blood transfusion use, with secondary endpoints of haemoglobin concentration at 6 weeks, length of hospital stay, rehabilitation duration to discharge, and 6-month mortality. Subgroup analysis compared outcomes in patients <80 yr old and patients >80 yr old. All analyses were performed by intention-to-treat. This trial was terminated early because of jurisdictional changes of more restrictive transfusion practices and changes in consent requirements.
Participants (=143) were recruited between February 2013 and May 2017. There was no difference observed in the incidence of blood transfusion between the treatment group (18/70) (26%) compared with the placebo group (27/73) (37%) (odds ratio for transfusion if receiving placebo: 1.70; 95% confidence interval [CI] 0.83-3.47; =0.15) and there was no overall difference in the median number of blood units transfused between groups (odds ratio 1.52; 95% CI 0.77-3.00; =0.22). Patients receiving i.v. iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L 108 g L; =0.01). No difference was observed in length of hospital stay, rehabilitation duration to discharge, or 6-month mortality. However, in younger patients without major bleeding, the use of placebo compared with i.v. iron was associated with an increased number of units of blood transfused (placebo transfusion incidence rate ratio 3.88; 95% CI 1.16-13.0; =0.03).
In anaemic patients undergoing surgery for hip fracture, i.v. iron did not reduce the overall proportion of patients receiving blood transfusion. The use of i.v. iron may reduce the amount of blood transfused in younger patients. The use of i.v. iron is associated with increased haemoglobin concentrations 6 weeks after the operation.
ACTRN12612000448842.
术前贫血与输血使用增加、术后并发症风险更高及患者发病率相关。IRON NOF试验旨在研究在髋部骨折手术期间给贫血患者静脉注射铁剂是否能减少输血需求并改善患者预后。
这项III期双盲、随机、安慰剂对照试验纳入了澳大利亚七家医院中年龄>60岁、术前贫血且接受股骨颈或转子下骨折手术的患者。患者按1:1随机分配，在手术时接受1000mg静脉注射羧基麦芽糖铁或安慰剂（生理盐水）。主要终点是输血使用情况，次要终点包括6周时的血红蛋白浓度、住院时间、出院康复时间及6个月死亡率。亚组分析比较了<80岁患者和>80岁患者的结局。所有分析均按意向性治疗进行。由于输血实践限制的管辖变化和同意要求的改变，该试验提前终止。
2013年2月至2017年5月期间招募了参与者（=143）。治疗组（18/70）（26%）与安慰剂组（27/73）（37%）相比，输血发生率无差异（接受安慰剂时输血的优势比：1.70；95%置信区间[CI]0.83 - 3.47；=0.15），两组之间输注血液单位的中位数也无总体差异（优势比1.52；95%CI 0.77 - 3.00；=0.22）。与安慰剂组相比，接受静脉注射铁剂的患者在干预后6周血红蛋白水平更高（血红蛋白116g/L对108g/L；=0.01）。住院时间、出院康复时间或6个月死亡率无差异。然而，在无大出血的年轻患者中，与静脉注射铁剂相比，使用安慰剂与输注血液单位数量增加相关（安慰剂输血发生率比3.88；95%CI 1.16 - 13.0；=0.03）。
在接受髋部骨折手术的贫血患者中，静脉注射铁剂并未降低接受输血患者的总体比例。静脉注射铁剂的使用可能减少年轻患者的输血量。静脉注射铁剂的使用与术后6周血红蛋白浓度升高相关。
ACTRN12612000448842。
