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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer®) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial

Authors: Seung Hyun Lee, Jae-Kwang Shim, Sarah Soh, Jong Wook Song, Byung Chul Chang, Sak Lee, Young-Lan Kwak

Published in: Trials | Issue 1/2018

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Abstract

Background

Anemia 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/design

In 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.

Discussions

From 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 registration

ClinicalTrials.​gov, Identifier: NCT02862665. Registered on August 2016.
Appendix
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Literature
1.
Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993;55(2):552–9.CrossRefPubMed
2.
Huyzen RJ, van Oeveren W, Wei F, Stellingwerf P, Boonstra PW, Gu YJ. In vitro effect of hemodilution on activated clotting time and high-dose thrombin time during cardiopulmonary bypass. Ann Thorac Surg. 1996;62(2):533–7.CrossRefPubMed
3.
Leal-Noval SR, Rincon-Ferrari MD, Garcia-Curiel A, et al. Transfusion of blood components and postoperative infection in patients undergoing cardiac surgery. Chest. 2001;119(5):1461–8.CrossRefPubMed
4.
De Santo LS, Romano G, Galdieri N, et al. RIFLE criteria for acute kidney injury in valvular surgery. J Heart Valve Dis. 2010;19(1):139–47. discussion 148PubMed
5.
Bucerius J, Gummert JF, Borger MA, et al. Stroke after cardiac surgery: a risk factor analysis of 16,184 consecutive adult patients. Ann Thorac Surg. 2003;75(2):472–8.CrossRefPubMed
6.
Koch CG, Li L, Van Wagoner DR, Duncan AI, Gillinov AM, Blackstone EH. Red cell transfusion is associated with an increased risk for postoperative atrial fibrillation. Ann Thorac Surg. 2006;82(5):1747–56.CrossRefPubMed
7.
Silverberg DS, Iaina A, Peer G, et al. Intravenous iron supplementation for the treatment of the anemia of moderate to severe chronic renal failure patients not receiving dialysis. Am J Kidney Dis. 1996;27(2):234–8.CrossRefPubMed
8.
Rohling RG, Zimmermann AP, Breymann C. Intravenous versus oral iron supplementation for preoperative stimulation of hemoglobin synthesis using recombinant human erythropoietin. J Hematother Stem Cell Res. 2000;9(4):497–500.CrossRefPubMed
9.
Schaefer RM, Schaefer L. Iron monitoring and supplementation: how do we achieve the best results? Nephrol Dial Transplant. 1998;13(Suppl 2):9–12.CrossRefPubMed
10.
Macdougall IC. Strategies for iron supplementation: oral versus intravenous. Kidney Int Suppl. 1999;69:S61–6.CrossRefPubMed
11.
Berniere J, Dehullu JP, Gall O, Murat I. Intravenous iron in the treatment of postoperative anemia in surgery of the spine in infants and adolescents. Rev Chir Orthop Reparatrice Appar Mot. 1998;84(4):319–22.PubMed
12.
Ranucci M, Baryshnikova E, Castelvecchio S, Pelissero G. Major bleeding, transfusions, and anemia: the deadly triad of cardiac surgery. Ann Thorac Surg. 2013;96(2):478–85.CrossRefPubMed
13.
Bregman DB, Morris D, Koch TA, He A, Goodnough LT. Hepcidin levels predict nonresponsiveness to oral iron therapy in patients with iron deficiency anemia. Am J Hematol. 2013;88(2):97–101.CrossRefPubMed
14.
Molitoris BA, Levin A, Warnock DG, et al. Improving outcomes from acute kidney injury. J Am Soc Nephrol. 2007;18(7):1992–4.CrossRefPubMed
15.
Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The important role for intravenous iron in perioperative patient blood management in major abdominal surgery: a randomized controlled trial. Ann Surg. 2016;264(1):41–6.CrossRefPubMedPubMedCentral
16.
Munoz M, Gomez-Ramirez S, Cuenca J, et al. Very-short-term perioperative intravenous iron administration and postoperative outcome in major orthopedic surgery: a pooled analysis of observational data from 2547 patients. Transfusion. 2014;54(2):289–99.PubMed
17.
Scott BH, Seifert FC, Grimson R. Blood transfusion is associated with increased resource utilisation, morbidity and mortality in cardiac surgery. Ann Card Anaesth. 2008;11(1):15–9.CrossRefPubMed
18.
Kiyama H, Ohshima N, Imazeki T, Yamada T. Autologous blood donation with recombinant human erythropoietin in anemic patients. Ann Thorac Surg. 1999;68(5):1652–6.CrossRefPubMed
19.
Gombotz H. Subcutaneous epoetin alfa as an adjunct to autologous blood donation before elective coronary artery bypass graft surgery. Semin Hematol. 1996;33(2 Suppl 2):69–70. discussion 71-62PubMed
20.
Yoo YC, Shim JK, Kim JC, Jo YY, Lee JH, Kwak YL. Effect of single recombinant human erythropoietin injection on transfusion requirements in preoperatively anemic patients undergoing valvular heart surgery. Anesthesiology. 2011;115(5):929–37.CrossRefPubMed
21.
Johansson PI, Rasmussen AS, Thomsen LL. Intravenous iron isomaltoside 1000 (Monofer(R)) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical trial (the PROTECT trial). Vox Sang. 2015;109(3):257–66.CrossRefPubMedPubMedCentral
22.
Garrido-Martin P, Nassar-Mansur MI, de la Llana-Ducros R, et al. The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial. Interact Cardiovasc Thorac Surg. 2012;15(6):1013–8.CrossRefPubMedPubMedCentral
Metadata
Title
The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer®) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial
Authors
Seung Hyun Lee
Jae-Kwang Shim
Sarah Soh
Jong Wook Song
Byung Chul Chang
Sak Lee
Young-Lan Kwak
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2545-3

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