Abstract
SummaryBackgroundPreoperative 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.MethodsIn 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.FindingsOf 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.InterpretationPreoperative 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.FundingUK National Institute of Health Research Health Technology Assessment Program.
Highlights
Preoperative anaemia affects 30–60% of all patients undergoing major elective surgery and is associated with an increased risk of blood transfusion, in-hospital complications, delayed hospital discharge, and poor recovery.[1,2] The commonest cause of anaemia is iron deficiency, either due to nutritional deficiency or blood loss leading to a state of absolute iron deficiency charac terised by low iron stores
Added value of this study The primary results of our trial show no evidence of clinical benefit in giving intravenous iron preoperatively to patients undergoing major abdominal surgery and provide the highest quality of evidence to date, with sufficient statistical power to make strong inferences about effectiveness
Study design and participants Preoperative intravenous iron to treat anaemia in major surgery (PREVENTT) was a multicentre, double-blind, parallel-group, randomised study in adult patients identified with anaemia 10–42 days before major open abdominal surgery at 46 UK tertiary care centres
Summary
Preoperative anaemia affects 30–60% of all patients undergoing major elective surgery and is associated with an increased risk of blood transfusion, in-hospital complications, delayed hospital discharge, and poor recovery.[1,2] The commonest cause of anaemia is iron deficiency, either due to nutritional deficiency or blood loss leading to a state of absolute iron deficiency charac terised by low iron stores. Surgical patients often have inflammation or chronic diseases that cause disruptions to the normal pathways for iron transport and iron metabolism. The master regulator of iron metabolism, hepcidin, is elevated, which inhibits iron transport out of cells. This process prevents dietary iron absorption and promotes sequestering of avail able iron into macrophages, leading to a state of func tional iron deficiency that in turn leads to anaemia of chronic disease.[3,4,5] treatment of anaemic surgical patients with oral iron is considered ineffective.[6]
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