IRON NOF trial: IV iron for anaemic patients with femoral fracture

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. Department of Anaesthetics, Princess Alexandra Hospital, Brisbane, Queensland, Australia. Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Victoria, Australia. Department of Anaesthesia, Sunshine Coast University Hospital, Birtinya, Queensland, Australia. Division of Surgery, The University of Western Australia, Perth, Western Australia, Australia.

BJA open. 2023;7:100222
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PICO Summary

Population

Patients with preoperative anaemia undergoing surgery for femoral neck or subtrochanteric fracture, enrolled in the IRON NOF trial across seven Australian hospitals (n= 143).

Intervention

Intravenous iron carboxymaltose (n= 70).

Comparison

Placebo (saline), (n= 73).

Outcome

All analyses were performed by intention-to-treat. The trial was terminated early because of jurisdictional changes of more restrictive transfusion practices and changes in consent requirements. 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]) 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]). Patients receiving intravenous iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L(-1) vs. 108 g L(-1)). No difference was observed in length of hospital stay, rehabilitation duration to discharge, or 6-month mortality. In younger patients without major bleeding, the use of placebo compared with intravenous 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]).
Abstract
BACKGROUND 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. METHODS 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. RESULTS 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(-1)vs 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). CONCLUSIONS 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. CLINICAL TRIAL REGISTRATION ACTRN12612000448842.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine