Iron supplementation for patients undergoing cardiac surgery: a protocol for a systematic review and meta-analysis of randomized controlled trials

Matthew J Cameron, Latifa Al Kharusi, Adam Gosselin, Pouya Gholipour Baradari, Anissa Chirico, Alexandre Amar-Zifkin, Stephen S Yang, Matthew J Cameron, Latifa Al Kharusi, Adam Gosselin, Pouya Gholipour Baradari, Anissa Chirico, Alexandre Amar-Zifkin, Stephen S Yang

Abstract

Background: Iron administration has been evaluated in several randomized controlled trials for the potential of increasing baseline hemoglobin values and decreasing the incidence of red blood cell transfusion during cardiac surgery. We describe the protocol for a study aiming to evaluate the efficacy and safety of perioperative iron administration in patients undergoing cardiac surgery.

Methods: We will search MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and the Web of Science, from inception to Nov. 19, 2020, for randomized controlled trials in any language evaluating the perioperative administration of iron in adult patients undergoing cardiac surgery; we will also include the first 50 results from Google Scholar. The primary outcome will be the incidence of red blood cell transfusion from the study intervention time until 8 weeks postoperatively. The secondary outcomes will be the number of red blood cell units transfused; change in ferritin level, reticulocyte count and hemoglobin concentration after iron administration; and adverse events. We will assess the risk of bias with the Cochrane Collaboration Risk of Bias Tool, and will analyze the primary and secondary outcomes using a random-effects model.

Interpretation: This study will summarize the current evidence about perioperative iron administration in patients undergoing cardiac surgery, help determine whether this intervention should be included in enhanced-recovery protocols, and shape future research if needed. The final manuscript will be submitted to a peer-reviewed journal.

Trial registration: PROSPERO no. CRD42020161927.

Trial registration: ClinicalTrials.gov NCT02632760.

Conflict of interest statement

Competing interests: None declared.

© 2021 CMA Joule Inc. or its licensors.

References

    1. Hung M, Besser M, Sharples LD, et al. The prevalence and association with transfusion, intensive care unit stay and mortality of pre-operative anaemia in a cohort of cardiac surgery patients. Anaesthesia. 2011;66:812–8.
    1. Gulack BC, Kirkwood KA, Shi W, et al. Secondary surgical-site infection after coronary artery bypass grafting: a multi-institutional prospective cohort study. J Thorac Cardiovasc Surg. 2018;155:1555–62.e1.
    1. Cutrell JB, Barros N, McBroom M, et al. Risk factors for deep sternal wound infection after cardiac surgery: influence of red blood cell transfusions and chronic infection. Am J Infect Control. 2016;44:1302–9.
    1. Likosky DS, Paone G, Zhang M, et al. Red blood cell transfusions impact pneumonia rates after coronary artery bypass grafting. Ann Thorac Surg. 2015;100:794–800. discussion 1.
    1. Wan X, Wang W, Liu J, et al. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014;14:135.
    1. Alameddine AK, Visintainer P, Alimov VK, et al. Blood transfusion and the risk of atrial fibrillation after cardiac surgery. J Card Surg. 2014;29:593–9.
    1. Engoren M, Schwann TA, Jewell E, et al. Is transfusion associated with graft occlusion after cardiac operations? Ann Thorac Surg. 2015;99:502–8.
    1. Tantawy H, Li A, Dai F, et al. Association of red blood cell transfusion and short- and longer-term mortality after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2018;32:1225–32.
    1. LaPar DJ, Hawkins RB, McMurry TL, et al. Preoperative anemia versus blood transfusion: Which is the culprit for worse outcomes in cardiac surgery? J Thorac Cardiovasc Surg. 2018;156:66–74.e2.
    1. Mazer CD, Whitlock RP, Fergusson DA, et al. Restrictive or liberal red-cell transfusion for cardiac surgery. N Engl J Med. 2017;377:2133–44.
    1. Patel KV. Epidemiology of anemia in older adults. Semin Hematol. 2008;45:210–7.
    1. Rossler J, Schoenrath F, Seifert B, et al. Iron deficiency is associated with higher mortality in patients undergoing cardiac surgery: a prospective study. Br J Anaesth. 2020;124:25–34.
    1. 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;27:234–8.
    1. Xu H, Duan Y, Yuan X, et al. Intravenous iron versus placebo in the management of postoperative functional iron deficiency anemia in patients undergoing cardiac valvular surgery: a prospective, single-blinded, randomized controlled trial. J Cardiothorac Vasc Anesth. 2019;33:2941–8.
    1. Spahn DR, Schoenrath F, Spahn GH, et al. Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial. Lancet. 2019;393:2201–12.
    1. Lee SH, Shim JK, Soh S, et al. 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. Trials. 2018;19:350.
    1. Koch TA, Myers J, Goodnough LT. Intravenous iron therapy in patients with iron deficiency anemia: dosing considerations. Anemia. 2015;2015:763576.
    1. Johansson PI, Rasmussen AS, Thomsen LL. Intravenous iron isomaltoside 1000 (Monofer®) reduces postoperative anaemia in preoperatively nonanaemic 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;109:257–66.
    1. Schack A, Berkfors AA, Ekeloef S, et al. The effect of perioperative iron therapy in acute major non-cardiac surgery on allogenic blood transfusion and postoperative haemoglobin levels: a systematic review and meta-analysis. World J Surg. 2019;43:1677–91.
    1. Ng O, Keeler BD, Mishra A, et al. Iron therapy for preoperative anaemia. Cochrane Database Syst Rev. 2019;12:CD011588.
    1. Cho BC, Serini J, Zorrilla-Vaca A, et al. Impact of preoperative erythropoietin on allogeneic blood transfusions in surgical patients: results from a systematic review and meta-analysis. Anesth Analg. 2019;128:981–92.
    1. Dai L, Mick SL, McCrae KR, et al. Preoperative anemia in cardiac operation: Does hemoglobin tell the whole story? Ann Thorac Surg. 2018;105:100–7.
    1. Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1.
    1. Richards T, Baikady RR, Clevenger B, et al. Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial. Lancet. 2020;396:1353–61.
    1. Ouzzani M, Hammady H, Fedorowicz Z, et al. Rayyan — a web and mobile app for systematic reviews. Syst Rev. 2016;5:210.
    1. Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.
    1. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: What is “quality of evidence” and why is it important to clinicians? BMJ. 2008;336:995–8.
    1. Wetterslev J, Jakobsen JC, Gluud C. Trial Sequential Analysis in systematic reviews with meta-analysis. BMC Med Res Methodol. 2017;17:39.

Source: PubMed

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