The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial

Garrido-Martín, Pilar; Nassar-Mansur, Mohamed Ibrahim; Llana-Ducrós, Ramiro de la; Virgos-Aller, Tirso; Fortunez, Patricia María Rodríguez; Ávalos-Pinto, Rosa; Jiménez-Sosa, Alejandro; Martínez‐Sanz, Rafael

doi:10.1093/icvts/ivs344

Cited by 88 publications

(84 citation statements)

References 24 publications

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“…The proportion of anaemic patients was significantly lower in the iron isomaltoside 1000 group compared to the placebo group at week 4 (92% of the placebo group patients were anaemic vs. 61·5% in the iron isomaltoside 1000 group). In the study by Garrido‐Martin and colleagues, they concluded that the use of IV or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements . One possible reason for this finding is that the patient might have received a lower dose of IV iron compared to our study.…”

Section: Discussionmentioning

confidence: 48%

Intravenous iron isomaltoside 1000 (Monofer^®) 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)

2015

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Background and ObjectivesThis trial explores whether intravenous iron isomaltoside 1000 (Monofer®) results in a better regeneration of haemoglobin levels and prevents anaemia compared to placebo in preoperative non-anaemic patients undergoing cardiac surgery.Study Design and MethodsThe trial is a prospective, double-blind, comparative, placebo-controlled trial of 60 non-anaemic patients undergoing cardiac surgery. The patients were randomized 1:1 to either 1000 mg intravenous iron isomaltoside 1000 administered perioperatively by infusion or placebo.ResultsMean preoperative haemoglobin in the active treatment group was 14·3 g/dl vs. 14·0 g/dl in the placebo group. At discharge 5 days after surgery, haemoglobin levels were reduced to 10·7 and 10·5 g/dl, respectively. One month after surgery, haemoglobin concentration had increased to an average of 12·6 g/dl vs. 11·8 g/dl (p = 0·012) and significantly more patients were non-anaemic in the intravenous iron isomaltoside 1000-treated group compared to the placebo group (38·5% vs. 8·0%; p = 0·019). There were no differences in side-effects between the groups.ConclusionA single perioperative 1000 mg dose of intravenous iron isomaltoside 1000 significantly increased the haemoglobin level and prevented anaemia 4 weeks after surgery, with a short-term safety profile similar to placebo. Future trials on potential clinical benefits of preoperative treatment with intravenous iron in non-anaemic patients are needed.

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Section: Discussionmentioning

confidence: 48%

Intravenous iron isomaltoside 1000 (Monofer^®) 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)

2015

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“…90 In another study, investigators randomly assigned 159 patients undergoing cardiac surgery requiring cardiopulmonary bypass, in a double-blinded manner, to one of three treatment groups. 91 Group I received 300 mg of intravenous iron(III) hydroxide sucrose complex per 24 h and one placebo tablet per 24 h during preoperative and postoperative hospitalization, with placebo only for 30 days after discharge. Group II received a placebo infusion while hospitalized, and one tablet of oral ferrous fumarate iron per day during hospitalization and for 30 days after discharge.…”

Section: Iron In Nontransplant Cardiac Surgerymentioning

confidence: 99%

“…Physical mobility and well-being were not recorded. 91 On the basis of these studies, no clear recommendation can be given with regard to the correction of iron deficiency in patients undergoing cardic surgery.…”

Section: Iron In Nontransplant Cardiac Surgerymentioning

confidence: 99%

Iron deficiency and cardiovascular disease

Haehling

Jankowska

Veldhuisen³

et al. 2015

Nat Rev Cardiol

237

151

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Iron deficiency affects up to one-third of the world's population, and is particularly common in elderly individuals and those with certain chronic diseases. Iron excess can be detrimental in cardiovascular illness, and research has now also brought anaemia and iron deficiency into the focus of cardiovascular medicine. Data indicate that iron deficiency has detrimental effects in patients with coronary artery disease, heart failure (HF), and pulmonary hypertension, and possibly in patients undergoing cardiac surgery. Around one-third of all patients with HF, and more than one-half of patients with pulmonary hypertension, are affected by iron deficiency. Patients with HF and iron deficiency have shown symptomatic improvements from intravenous iron administration, and some evidence suggests that these improvements occur irrespective of the presence of anaemia. Improved exercise capacity has been demonstrated after iron administration in patients with pulmonary hypertension. However, to avoid iron overload and T-cell activation, it seems that recipients of cardiac transplantations should not be treated with intravenous iron preparations.

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“…Only in subgroups of patients with surgery for intracapsular fractures or with preoperative Hb > 12 g/dl, post-hoc analysis showed significant reductions in RBC transfusion requirements in the IS arm (14 vs 46% [p < 0.005] and 19 vs 35% [p < 0.05], respectively). The last trial was a double-blind study performed in 159 patients undergoing cardiopulmonary bypass surgery [75]. Group 1 received i.v.…”

Section: Perioperative Iron Treatmentmentioning

confidence: 99%

Iron sucrose – characteristics, efficacy and regulatory aspects of an established treatment of iron deficiency and iron-deficiency anemia in a broad range of therapeutic areas

Béguin¹,

Jaspers

2014

Expert Opinion on Pharmacotherapy

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The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial

Cited by 88 publications

References 24 publications

Iron deficiency and cardiovascular disease

Iron sucrose – characteristics, efficacy and regulatory aspects of an established treatment of iron deficiency and iron-deficiency anemia in a broad range of therapeutic areas

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