Ferric carboxymaltose with or without erythropoietin in anemic patients with hip fracture: a randomized clinical trial

Bernabéu-Wittel, Máximo; Romero, Manuel; Ollero-Baturone, Manuel; Aparicio, Reyes Jiménez; Murcia-Zaragoza, José; Rincón-Gómez, Manuel; Monte-Secades, Rafael; Melero-Bascones, María; Rosso, Chelsea R. Del; Ruiz-Cantero, Alberto

doi:10.1111/trf.13624

Cited by 60 publications

(151 citation statements)

References 53 publications

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“…In hip fracture repair surgery, five studies (three RCTs, two observational; 2063 patients) have evaluated the effect of perioperative intravenous iron administration (iron sucrose or ferric carboxymaltose), with or without EPO, on transfusion requirements, with varying results (Table ).…”

Section: Resultsmentioning

confidence: 99%

“…Conversely, in a third RCT that only included patients with Hb <12 g/dl, treatment with intravenous iron, with or without EPO, did not reduce transfusion rates in relation to placebo (52%, 52%, 54%, respectively). However, compared to placebo, the group receiving intravenous iron and EPO showed higher Hb levels at discharge (10·3 g/dl vs. 9·7 g/dl, respectively; P = 0·009) and 60 days after the intervention (12·5 g/dl vs. 11·9 g/dl, respectively; P = 0·05), with fewer patients being anaemic 60 days after discharge (52% vs. 39%, respectively; P = 0·015), though there were no differences in quality of life scores .…”

Section: Resultsmentioning

confidence: 99%

“…However, there were differences between RCTs regarding mean time to surgery from hospital admission (Table ) and transfusion protocols that might have influenced the results. Thus, patients may receive a RBC transfusion when: (1) postoperative Hb <8 g/dl or <9 g/dl in patients with a history of cardiorespiratory conditions, or any Hb in patients with symptoms of untreated anaemia ; (2) postoperative Hb <9 g/dl or any discomfort or pathologic signs from cardiovascular, central nervous or renal system related to anaemia ; or (3) postoperative Hb <7 g/dl independently of symptoms (3 RBC units) or postoperative Hb 7·1–8·9 g/dl plus severe symptoms and/or cardiovascular risk factors (2 RBC units) .…”

Section: Resultsmentioning

confidence: 99%

“…Thus, the overall incidence of ADEs with intravenous iron, with or without EPO, was 1·13%. Of these 25 ADEs, 13 were gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or constipation) , five hypotension (one severe) , two headache , two general discomfort , one skin rash , one flushing and tingling in the lips , and one anaphylaxis . However, neither severe hypotension nor anaphylaxis was considered treatment‐related by study authors .…”

Section: Resultsmentioning

confidence: 99%

“…For instance, in the multicentre, double‐blinded RCT by Bernabeu‐Vittel et al . inclusion criteria and transfusion protocol might have been misleading. They included 306 anaemic hip fracture patients (Hb 9–12 g/dl).…”

Section: Discussionmentioning

confidence: 99%

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Short‐term perioperative iron in major orthopedic surgery: state of the art

Gómez‐Ramírez

Maldonado-Ruiz²,

Campos-Garrigues

et al. 2018

Vox Sanguinis

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In major orthopaedic surgery, it is recommended to detect and correct preoperative anaemia several weeks prior to surgery. However, in many cases, the procedure is urgent or the patient is evaluated shortly before the intervention. As iron deficiency is the leading cause of perioperative anaemia, an exhaustive review of the literature was performed to assess the efficacy and safety of short‐term perioperative intravenous, with or without erythropoietin, or postoperative oral or intravenous supplementation in major orthopaedic surgery. Overall, 20 studies met the inclusion criteria. There were 13 randomized trials (moderate quality) and seven observational studies (low to very low quality). The primary outcomes were reduction in transfusion requirements, haemoglobin increase and medication side‐effects during the study period. Data analysis showed that postoperative oral iron administration neither increased haemoglobin nor reduced transfusion requirements, and it was associated with significant gastrointestinal adverse effects (15%). In contrast, for some patient populations, perioperative or postoperative administration of intravenous iron, with or without recombinant erythropoietin, may reduce transfusion requirements and/or hasten the recovery from postoperative, with few clinically relevant adverse effects (<2%). However, discrepancies between randomized trials and observational studies on the possible beneficial effects of short‐term perioperative intravenous iron administration were found for patients undergoing surgery for hip fracture repair. Further studies are needed to elucidate when the treatment should be started, which combination of drugs should be used, and which patient groups would be most benefit.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Short‐term perioperative iron in major orthopedic surgery: state of the art

Gómez‐Ramírez

Maldonado-Ruiz²,

Campos-Garrigues

et al. 2018

Vox Sanguinis

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Risk of Infection Associated With Administration of Intravenous Iron

et al. 2021

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IMPORTANCEIntravenous iron is recommended by many clinical guidelines based largely on its effectiveness in reducing anemia. However, the association with important safety outcomes, such as infection, remains uncertain. OBJECTIVE To examine the risk of infection associated with intravenous iron compared with oral iron or no iron. DATA SOURCES Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials (RCTs) from 1966 to January 31, 2021. Ongoing trials were sought from ClinicalTrials.gov, CENTRAL, and the World Health Organization International Clinical Trials Search Registry Platform. STUDY SELECTION Pairs of reviewers identified RCTs that compared intravenous iron with oral iron or no iron across all patient populations, excluding healthy volunteers. Nonrandomized studies published since January 1, 2007, were also included. A total of 312 full-text articles were assessed for eligibility. DATA EXTRACTION AND SYNTHESIS Data extraction and risk of bias assessments were performed according to the Preferred Reporting Items of Systematic Reviews and Meta-analyses (PRISMA) and Cochrane recommendations, and the quality of evidence was assessed using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach. Two reviewers extracted data independently. A random-effects model was used to synthesize data from RCTs. A narrative synthesis was performed to characterize the reporting of infection. MAIN OUTCOMES AND MEASURESThe primary outcome was risk of infection. Secondary outcomes included mortality, hospital length of stay, and changes in hemoglobin and red blood cell transfusion requirements. Measures of association were reported as risk ratios (RRs) or mean differences.RESULTS A total of 154 RCTs (32 920 participants) were included in the main analysis. Intravenous iron was associated with an increased risk of infection when compared with oral iron or no iron (RR, 1.17; 95% CI, 1.04-1.31; I 2 = 37%; moderate certainty of evidence). Intravenous iron also was associated with an increase in hemoglobin (mean difference, 0.57 g/dL; 95% CI, 0.50-0.64 g/dL; I 2 = 94%) and a reduction in the risk of requiring a red blood cell transfusion (RR, 0.93; 95% CI, 0.76-0.89; I 2 = 15%) when compared with oral iron or no iron. There was no evidence of an effect on mortality or hospital length of stay. (continued) Key Points Question In patients who require treatment with intravenous iron, what is the evidence that this intervention increases the risk of developing a new infection? Findings In this systematic review and meta-analysis of 154 randomized clinical trials that included 32 920 participants, intravenous iron was associated with an increased risk of infection. Meaning The results of this study suggest that, despite broad advocacy in clinical guidelines, intravenous iron may increase the risk of infection, which must be balanced with the potential benefits of treating anemia and reducing blood transfusion requirements.

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