PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Participants (n=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; P=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; P=0.22). Patients receiving i.v. iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L-1vs 108 g L-1; P=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; P=0.03).
UNASSIGNED: 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.
UNASSIGNED: ACTRN12612000448842.
UNASSIGNED: 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.
UNASSIGNED: Participants (n=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; P=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; P=0.22). Patients receiving i.v. iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L-1vs 108 g L-1; P=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; P=0.03).
UNASSIGNED: 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.
UNASSIGNED: ACTRN12612000448842.
摘要：
■术前贫血与输血使用增加有关，术后并发症的风险更大，和患者发病率。IRONNOF试验旨在研究髋部骨折手术期间贫血患者静脉内注射铁剂是否减少了输血的需要并改善了患者的预后。
■此阶段III双盲，随机化，安慰剂对照试验纳入了7家澳大利亚医院中年龄>60岁的术前贫血患者,这些患者接受了股骨颈或股骨粗隆下骨折手术.患者按1：1的比例随机分配，在手术中接受静脉内接受1000mg的铁羧基麦芽糖或安慰剂（盐水）。主要终点是输血使用，6周时血红蛋白浓度的次要终点，住院时间,康复持续时间至出院，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。所有分析均通过意向治疗进行。由于更严格的输血实践的管辖权变化和同意要求的变化，该试验被提前终止。
■参与者（n=143）在2013年2月至2017年5月之间招募。治疗组（18/70）（26％）与安慰剂组（27/73）（37％）之间的输血发生率没有差异（接受安慰剂的输血赔率比：1.70；95％置信区间[CI]0.83-3.47；P=0.15），组间输血的中位血数没有总体差异（赔率比1.52；95％CI0.77-3.22）=P。与安慰剂组相比，接受静脉注射铁的患者在干预后6周的血红蛋白较高（Hb116gL-1vs108gL-1；P=0.01）。住院时间没有观察到差异，康复持续时间至出院，或6个月死亡率。然而,在没有大出血的年轻患者中，与静脉注射铁相比,使用安慰剂与输血单位数增加相关(安慰剂输血发生率比3.88;95%CI1.16-13.0;P=0.03).
■在接受髋部骨折手术的贫血患者中，静脉内铁并没有降低接受输血的患者的总体比例。静脉内使用铁可以减少年轻患者的输血量。静脉内使用铁与术后6周血红蛋白浓度增加有关。
■ACTRN12612000448842。
■此阶段III双盲，随机化，安慰剂对照试验纳入了7家澳大利亚医院中年龄>60岁的术前贫血患者,这些患者接受了股骨颈或股骨粗隆下骨折手术.患者按1：1的比例随机分配，在手术中接受静脉内接受1000mg的铁羧基麦芽糖或安慰剂（盐水）。主要终点是输血使用，6周时血红蛋白浓度的次要终点，住院时间,康复持续时间至出院，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。所有分析均通过意向治疗进行。由于更严格的输血实践的管辖权变化和同意要求的变化，该试验被提前终止。
■参与者（n=143）在2013年2月至2017年5月之间招募。治疗组（18/70）（26％）与安慰剂组（27/73）（37％）之间的输血发生率没有差异（接受安慰剂的输血赔率比：1.70；95％置信区间[CI]0.83-3.47；P=0.15），组间输血的中位血数没有总体差异（赔率比1.52；95％CI0.77-3.22）=P。与安慰剂组相比，接受静脉注射铁的患者在干预后6周的血红蛋白较高（Hb116gL-1vs108gL-1；P=0.01）。住院时间没有观察到差异，康复持续时间至出院，或6个月死亡率。然而,在没有大出血的年轻患者中，与静脉注射铁相比,使用安慰剂与输血单位数增加相关(安慰剂输血发生率比3.88;95%CI1.16-13.0;P=0.03).
■在接受髋部骨折手术的贫血患者中，静脉内铁并没有降低接受输血的患者的总体比例。静脉内使用铁可以减少年轻患者的输血量。静脉内使用铁与术后6周血红蛋白浓度增加有关。
■ACTRN12612000448842。
