IRON NOF trial: IV iron for anaemic patients with femoral fracture.
anaemia
haemoglobin
hip fracture
intravenous iron
iron deficiency
neck of femur
transfusion
Journal
BJA open
ISSN: 2772-6096
Titre abrégé: BJA Open
Pays: England
ID NLM: 9918419157906676
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
received:
31
01
2023
revised:
28
06
2023
accepted:
21
07
2023
medline:
28
8
2023
pubmed:
28
8
2023
entrez:
28
8
2023
Statut:
epublish
Résumé
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 ( 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.
Sections du résumé
Background
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.
Methods
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.
Results
UNASSIGNED
Participants (
Conclusions
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.
Clinical trial registration
UNASSIGNED
ACTRN12612000448842.
Identifiants
pubmed: 37638076
doi: 10.1016/j.bjao.2023.100222
pii: S2772-6096(23)00101-6
pmc: PMC10457485
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100222Informations de copyright
© 2023 The Authors.
Références
Osteoporos Int. 2006 Dec;17(12):1726-33
pubmed: 16983459
Anaesthesia. 2015 Apr;70(4):483-500
pubmed: 25764405
Public Health Nutr. 2009 Apr;12(4):444-54
pubmed: 18498676
Arch Orthop Trauma Surg. 2004 Dec;124(10):699-701
pubmed: 15517315
Mayo Clin Proc. 2015 Jan;90(1):12-23
pubmed: 25572192
J Arthroplasty. 2005 Jun;20(4 Suppl 2):51-4
pubmed: 15991130
Am J Physiol Gastrointest Liver Physiol. 2006 Feb;290(2):G199-203
pubmed: 16407589
N Engl J Med. 2011 Dec 29;365(26):2453-62
pubmed: 22168590
Arch Intern Med. 2005 Oct 24;165(19):2214-20
pubmed: 16246985
J Epidemiol Community Health. 1988 Dec;42(4):365-9
pubmed: 3256579
Acta Haematol. 2009;122(2-3):78-86
pubmed: 19907144
Lancet Haematol. 2016 Sep;3(9):e401-2
pubmed: 27570084
Blood Transfus. 2018 Jul;16(4):324-325
pubmed: 29517972
Eur J Heart Fail. 2016 Jul;18(7):774-85
pubmed: 27121474
Transfusion. 2017 Jun;57(6):1347-1358
pubmed: 28150313
Blood. 2019 Jan 3;133(1):40-50
pubmed: 30401705
Lancet. 2020 Oct 24;396(10259):1353-1361
pubmed: 32896294
Lancet. 2020 Feb 29;395(10225):698-708
pubmed: 32050090
Age Ageing. 2021 Jan 8;50(1):127-134
pubmed: 32542370
Intensive Care Med. 2016 Nov;42(11):1715-1722
pubmed: 27686346
Blood. 2019 Jan 3;133(1):30-39
pubmed: 30401704
BMC Geriatr. 2008 Jan 14;8:1
pubmed: 18194534
J Orthop Trauma. 2004 Jul;18(6):369-74
pubmed: 15213502
Anaesthesia. 2019 Jun;74(6):714-725
pubmed: 30963552
Age Ageing. 2019 Sep 1;48(5):751-755
pubmed: 31127269
J Bone Joint Surg Am. 1999 Jan;81(1):2-10
pubmed: 9973048
Br J Haematol. 1989 Mar;71(3):437-42
pubmed: 2930723
N Engl J Med. 2005 Mar 10;352(10):1011-23
pubmed: 15758012
Injury. 2011 Feb;42(2):178-82
pubmed: 20850741
Bone Joint J. 2019 Aug;101-B(8):1015-1023
pubmed: 31362544
Br J Anaesth. 2014 Sep;113(3):402-9
pubmed: 24780615
Age Ageing. 2008 Mar;37(2):173-8
pubmed: 18349013
Semin Hematol. 2008 Oct;45(4):210-7
pubmed: 18809090
J Am Med Dir Assoc. 2007 Jun;8(5):322-7
pubmed: 17570312
JAMA. 1999 May 12;281(18):1714-7
pubmed: 10328071
Schweiz Med Wochenschr. 1970 Feb 14;100(7):301-3
pubmed: 5413918
N Engl J Med. 2019 Sep 19;381(12):1148-1157
pubmed: 31532961
Cochrane Database Syst Rev. 2008 Jul 16;(3):CD000337
pubmed: 18646065
J Orthop Trauma. 2002 Jan;16(1):39-44
pubmed: 11782632