Abstract
BackgroundAnemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery (including combined coronary artery bypass grafting). This trial explores whether intravenously administered iron isomaltoside 1000 (Monofer®) results in better clinical outcomes in patients undergoing complex heart valve surgery who are expected to receive transfusion.Methods/designIn this prospective, single-center, double-blinded, randomized controlled trial, 214 patients undergoing reoperation or multiple valve surgery are randomly allocated to either the iron isomaltoside 1000 (IVFe) or the control group from August 2016 to August 2018. The IVFe group receives iron isomaltoside 1000 mg (maximum dose 20 mg/kg) intravenously 3 days before and after the surgery. The control group receives an equivalent volume of normal saline. The primary endpoint is transfusion requirement (more than 1 unit of packed erythrocytes) for postoperative care until discharge and secondary endpoint are major complications, such as delayed ventilator therapy, acute kidney injury, and mortality. Reticulocyte count, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles, urinary analysis, and chemical profiles are measured for three preoperative baseline-data days and just before surgery, except for hepcidin. After surgery, daily routine basic laboratory tests are measured just before discharge and reticulocyte count, iron profiles, and hepcidin are repeatedly checked for three postoperative days.DiscussionsFrom our study, we can clarify the following points: the first is the perioperative IVFe effect on the demand for transfusion, and clinical outcomes in reoperation or complex valve surgery and the second is the role of hepcidin in the effect of IVFe on the hemoglobin level increase.Trial registrationClinicalTrials.gov, Identifier: NCT02862665. Registered on August 2016.
Highlights
Anemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery
Several studies have been published about the effect of erythropoietic agents such as Recombinant Human Erythropoietin [18–20] and intravenously administered (IV) iron isomaltoside 1000 (Monofer®) [21, 22]
For Recombinant Human Erythropoietin (rHuEPO), the theoretical basis for selecting the timing of rHuEPO administration was based on the assumption that a preemptive single dose of rHuEPO may mitigate the inflammatory response-induced blunting of erythropoiesis; this hypothesis remains speculative unless we evaluate the representative inflammatory markers
Summary
Anemia is a common postoperative disorder in cardiac surgery patients after cardiopulmonary bypass (CPB) [1, 2]. Some authors have suggested a role for intravenously administered (IV) iron in correcting anemia after orthopedic and oncological surgery, and in renal and obstetric patients [10, 11], but this route still remains controversial in cardiac surgery. Hepcidin acts by binding to the iron transport protein ferroportin, blocking iron absorption from the intestine and iron release from macrophages, leading to reduced iron delivery to erythroid precursors [13]. This hepcidin’s role under IV iron replacement remains unclear in patients undergoing cardiovascular surgery. We tried to assess the role of hepcidin as a biomarker, as well as any association of hematological parameters with outcome
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