ABSTRACT
BACKGROUND: Perioperative anemia is common in cardiac surgery. Few studies investigated the effect of postoperative intravenous (IV) iron supplementation and were mostly inconclusive. METHODS: Design: A randomized single-center, double-blind, placebo-controlled, parallel-group trial. PARTICIPANTS: 195 non-anemic patients were recruited from December 2018 to December 2020: 97 patients received 1 g of ferric carboxymaltose (FCM) and 98 patients received 100 mL of physiological serum on postoperative day 1. MEASUREMENTS: hemoglobin levels, reticulocyte count, serum iron, serum ferritin, and transferrin saturation were measured at induction of anesthesia, postoperative days 1, 5, and 30. Transfusion rate, duration of mechanical ventilation, critical care unit length of stay, and side effects associated with IV iron administration were measured. The primary outcome was hemoglobin level on day 30. Secondary outcomes included iron balance, transfused red cell packs, and critical care unit length of stay. RESULTS: At day 30, the hemoglobine level was higher in the FCM group than in the placebo group (mean 12.9 ± 1.2 vs. 12.1 ± 1.3 g/dL (95%CI 0.41-1.23, p-value <0.001)). Patients in the FCM group received fewer blood units (median 1[0-2] unit vs. 2 [0-3] units, p-value = 0.037) and had significant improvement in iron balance compared to the control group. No side effects associated with FCM administration were reported. CONCLUSION: In this randomized controlled trial, administration of FCM on postoperative day 1 in non-anemic patients undergoing cardiac surgery increased hemoglobin levels by 0.8 g/dL on postoperative day 30, leading to reduced transfusion rate, and improved iron levels on postoperative day 5 and 30. CLINICAL TRIAL REGISTRY NUMBER: NCT03759964.
Subject(s)
Cardiac Surgical Procedures , Ferric Compounds , Humans , Ferric Compounds/therapeutic use , Ferric Compounds/pharmacology , Iron , HemoglobinsABSTRACT
OBJECTIVES: The aim of this study was to examine whether intravenous iron III-hydroxide sucrose complex (IHSC) used alone was sufficient to provide rapid correction of anemia after cardiac surgery and whether additional stimulation of erythropoiesis is possible by means of a single low dose of recombinant-human erythropoietin (r-HuEPO) administration. DESIGN: Prospective, randomized, double-blind study. SETTING: The study was conducted in a university hospital. PARTICIPANTS: One hundred twenty American Society of Anesthesiologists II or III patients, who underwent elective cardiac surgery using cardiopulmonary bypass and in whom postpump hemoglobin ranged between 7 and 10 g/dL. INTERVENTIONS: Patients were divided into 3 groups: group I = control; group II received postoperative intravenous iron supplementation with an iron III-hydroxide sucrose complex (IHSC); and group III received IV iron and a single dose of r-HuEPO (300 U/kg). MEASUREMENTS AND RESULTS: No significant difference in transfusion needs was observed among the 3 groups (22%, 25%, and 17% of patients transfused in groups I, II, and III, respectively). Hemoglobin levels, reticulocyte counts, and serum ferritin levels were evaluated at different time intervals (until day 30 postoperatively). No side effects because of iron administration were noted in the study. Reticulocyte counts increased rapidly at day 5 (2.24% +/- 1.11%, 1.99% +/- 1.44%, and 3.84% +/- 2.02% in groups I, II, and III, respectively) and decreased after day 15 in the 3 groups. Ferritin levels increased significantly at day 5 in the 2 treated groups (899.33 +/- 321.55 ng/mL in group II, 845.75 +/- 289.96 ng/mL in group III v 463.15 +/- 227.74 ng/mL in group I). In group I, ferritin levels, after a slight elevation on day 5, decreased at day 15 to lower than baseline levels. No significant difference in hemoglobin increase was noted among the 3 groups. CONCLUSION: Postoperative intravenous iron supplementation alone or in combination with a single dose of r-HuEPO (300 U/kg) is not effective in correcting anemia after cardiac surgery.