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Table 1 Randomized controlled trials of intravenous (i.v.) iron in major surgery

From: Iron Metabolism: An Emerging Therapeutic Target in Critical Illness

Study, year [ref], number (n) of patients Population Intervention Outcomes
Kim, 2017 (FAIRY trial) [48]
n = 454
Anemia post-radical gastrectomy 500–1000 mg i.v. FCM Significantly more Hb responders No significant differences in QoL
Johansson, 2015 (PROTECT trial) [49]
n = 60
Non-anemic patients undergoing cardiac surgery 100 mg i.v. iron isomaltoside More non-anemic patients in i.v. iron group
Higher Hb 1 month postoperative in i.v. iron group
Bernabeu-Wittel, 2016 [50]
n = 306
Hip fracture surgery 1 g i.v. FCM+  40,000 IU s.c. EPO Higher Hb at discharge and 60-days post-discharge
No significant differences in ABT, mortality, HRQoL, adverse events.
Froessler, 2016 [51]
n = 72
Abdominal surgery with IDA 500–1000 mg i.v. FCM Reduced ABT
Improved preoperative Hb
Improved postoperative Hb
Reduced LOS
Intravenous iron for Treatment of Anemia before Cardiac Surgery (ITACS; ClincialTrials.gov Identifier: NCT02632760) Anemic patients before elective cardiac surgery 1 g i.v. FCM (or similar product) Primary outcome: Number of days alive and out of hospital from surgery to 30 days post-surgery
Preoperative Intravenous Iron to Treat Anemia in Major Surgery (PREVENTT; ClinicalTrials.gov Identifier: NCT01692418) Anemic patients before major open abdominal surgery 1 g i.v. FCM Primary outcome: ABT requirement
Intravenous Iron, Functional Recovery and Delirium in Patients with Hip Fracture (FEDEREF; EudraCT: 2014–001923-53) Hip fracture patients 200 mg iron sucrose on days 1, 3 and 5 from admission Primary outcome: Functional variables, including ability to perform activities of daily living and walking.
Cognitive variables, including cognitive status and incidence of delirium ABT requirement
  1. ABT allogeneic blood transfusion, EPO erythropoietin, FCM ferric carboxymaltose, Hb hemoglobin, HRQoL health-related quality of life, IDA iron-deficiency anemia, LOS length of stay, QoL quality of life, s.c. subcutaneous