Preoperative IV iron to anemic patients may not reduce blood transfusion need, death: Lancet
London, UK: The administration of preoperative intravenous iron to anemic patients 10–42 days before elective major abdominal surgery was not effective than a placebo for reducing the need for blood transfusion, according to findings from the PREVENTT trial. The study is published in the journal Lancet.
About 30-60% of the patients undergoing major elective surgery are affected by preoperative anemia. It is associated with an increased risk of blood transfusion, in-hospital complications, poor recovery, and delayed hospital discharge. Toby Richards, Fiona Stanley Hospital, Perth, WA, Australia, and colleagues aimed to test the hypothesis whether the administration of intravenous iron to anemic patients before major open elective abdominal surgery would help in correcting anemia, improving patient outcomes, and reducing the need for blood transfusions.
The researchers recruited adult participants halving anemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centers. Anemia was defined as hemoglobin of less 120 g/L for women and 130 g/L for men.
487 were randomly assigned in the ratio 1:1 to receive intravenous iron (n=244) or placebo (n=243) 10–42 days before surgery. complete data for the primary endpoints were available for 474 (97%) individuals. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and the placebo was 100 mL normal saline, both given as an infusion over 15 min.
Coprimary endpoints were the risk of the composite outcome of blood transfusion or death, and the number of blood transfusions from randomization to 30 days postoperatively.
Key findings of the study include:
- 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).
- There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98).
- There were no significant differences between the two groups for any of the prespecified safety endpoints.
"Findings from the trial showed that intravenous iron was not superior to placebo when administered to patients with anaemia 10–42 days before elective major abdominal surgery in reducing blood transfusion or death in the perioperative period," concluded the authors.
The study, "Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial," is published in the journal Lancet.