Evidence map›Paper›PMID 25900643›Full record

Trial reportVox sanguinis2015

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).

P I Johansson, A S Rasmussen, L L Thomsen

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vox sanguinis, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03094182 (Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery), which is not on this map. Cited by 51 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 7 pooled it
4.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03094182 naunknown statusnot on this mapstarted 2017, after this paper: background citation

Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery

TypeinterventionalSponsorYonsei UniversityRan2017 to 2019Enrolled58ConditionsFacial Asymmetry, Retrognathism, PrognathismArmsIron Isomaltoside 1000, Normal saline
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 7 syntheses or guidelines pooled it, 129 citations in OpenAlex.

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  7. Intravenous iron therapy for non-anaemic, iron-deficient adults.The Cochrane database of systematic reviews · 2019
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  10. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021
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  20. Which should be the target for preoperative hemoglobin optimization?Blood transfusion = Trasfusione del sangue · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

P I JohanssonDepartment of Clinical Immunology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
A S RasmussenDepartment of Clinical Immunology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
L L ThomsenPharmacosmos A/S, Holbaek, Denmark.
Copenhagen University Hospital · DKPharmacosmos (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

AgedAged, 80 and overAnemiaCoronary Artery BypassCoronary DiseaseDisaccharidesDouble-Blind MethodElective Surgical ProceduresFemaleFerric CompoundsHemoglobinsHumansMaleMiddle AgedPlacebo EffectPostoperative ComplicationsDisaccharidesFerric CompoundsHemoglobinsiron isomaltoside 1000anaemiacoronary artery bypass surgeryiron

Identifiers

PMID25900643
PMCPMC4690506
OpenAlexW1723550313

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.