ferric-carboxymaltose and Anemia

A number of intravenous iron formulations have been developed over the past 65 years which rely on dextran or other compounds to prevent uncontrolled release of free iron to the circulation. High molecular weight dextran was associated with a number of serious adverse reactions and was removed from markets worldwide in 2009. The preponderance of published evidence suggests that the formulations of parenteral iron currently available in the United States, including low molecular weight iron dextran, are all safe and effective and there are no major, clinically important differences among them in terms of either efficacy or safety. For patients with chemotherapy induced anemia or with anemia of end stage renal disease who are being treated with hemodialysis, it is reasonable to use any of the iron formulations, including iron sucrose and ferric gluconate, as frequent patient encounters with health caregivers are a routine part of care and the need to administer multiple low doses of IV iron is not a major disadvantage. However, a single infusion of a total iron dose is as effective and safe when giving iron preparations containing low molecular weight iron dextran, ferumoxytol, iron isomaltoside, or ferric carboxymaltose. Use of a single total dose infusion results in a decreased number of intravenous infusions with a lower cumulative risk for infusion reactions or extravasations, a reduced need for multiple office visits and repeated utilization of medical staff, and increased convenience for physicians and patients.

Topics: Anemia; Drug Compounding; Ferric Compounds; Ferrosoferric Oxide; Humans; Infusions, Intravenous; Iron; Kidney Failure, Chronic; Maltose; Renal Dialysis

Chronic heart failure is a substantial public health problem. Anemia is an important comorbidity frequently observed in patients with the disease and, in heart failure, anemia has only recently started to attract systematic epidemiological and therapeutical research endeavor. This article describes the many aspects of anemia in chronic heart failure, starting with the ongoing discussion of how to define anemia, which has important consequences for the estimation of its prevalence and incidence. Further, we discuss prognostic implications of anemia in patients with chronic or acute heart failure, the etiology of anemia in heart failure and treatment possibilities. Such therapeutic avenues embrace intravenous iron preparations and subcutaneous administration of erythropoietin and its derivatives, all of which have been extensively studied over the last several years. Finally, this article describes the potential costs incurred by treating anemic patients with heart failure.

Topics: Anemia; Comorbidity; Darbepoetin alfa; Erythropoietin; Ferric Compounds; Heart Failure; Hematinics; Humans; Injections, Intravenous; Iron Compounds; Maltose; Prognosis; Risk Assessment; Risk Factors; United States

To determine whether intravenous (IV) or oral iron suppletion is superior in improving physical fitness in anemic children with inflammatory bowel disease (IBD).. We conducted a clinical trial at 11 centers. Children aged 8-18 with IBD and anemia (defined as hemoglobin [Hb] z-score < -2) were randomly assigned to a single IV dose of ferric carboxymaltose or 12 weeks of oral ferrous fumarate. Primary end point was the change in 6-minute walking distance (6MWD) from baseline, expressed as z-score. Secondary outcome was a change in Hb z-score from baseline.. We randomized 64 patients (33 IV iron and 31 oral iron) and followed them for 6 months. One month after the start of iron therapy, the 6MWD z-score of patients in the IV group had increased by 0.71 compared with -0.11 in the oral group (P = .01). At 3- and 6-month follow-ups, no significant differences in 6MWD z-scores were observed. Hb z-scores gradually increased in both groups and the rate of increase was not different between groups at 1, 3, and 6 months after initiation of iron therapy (overall P = .97).. In this trial involving anemic children with IBD, a single dose of IV ferric carboxymaltose was superior to oral ferrous fumarate with respect to quick improvement of physical fitness. At 3 and 6 months after initiation of therapy, no differences were discovered between oral and IV therapies. The increase of Hb over time was comparable in both treatment groups.. NTR4487 [Netherlands Trial Registry].

Topics: Administration, Oral; Anemia; Anemia, Iron-Deficiency; Child; Ferric Compounds; Hemoglobins; Humans; Inflammatory Bowel Diseases; Iron; Maltose; Treatment Outcome

Acute gastrointestinal bleeding (GIB) is a life-threatening emergency with a critical economic burden. As a result of bleeding, anaemia often requires intravenous or oral iron supplementation. Elderly patients are even more prone to untoward outcomes after hospital discharge if iron supplementation is inefficient. There is a gap in current guidelines on which supplementation route clinicians should choose. We aim to investigate the effect of one dose of intravenous iron therapy versus 3-month oral iron administration on anaemia in an elderly population.. The FIERCE study is an open-label, randomised controlled, two-armed trial. At least 48 hours after the acute non-variceal GIB treatment, patients will be recruited in participating centres. A random sequence generator will allocate the participants to group A (intravenous ferric carboxymaltose, 1000 mg) or group B (oral ferrous sulfate (FS), ca. 200 mg every day) with an allocation ratio of 1:1 on the day of the planned discharge from the hospital. Randomisation will be stratified for participating centres and the need for transfusion within the same hospitalisation before recruitment to the trial. Quality of life assessment, functional measurement and laboratory tests will be performed at baseline, 1 and 3 months±7 days after enrolment to the trial. The primary endpoint is a composite endpoint, including all-cause mortality, anaemia-associated unplanned emergency visit and anaemia-associated unplanned hospital admission within 3 months of enrolment in the trial.. The study has been approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (46395-5/2021/EÜIG). We will disseminate our results to the medical community and will publish our results in peer-reviewed journals.. The trial has been registered at ClinicalTrials.gov (NCT05060731).

Topics: Aged; Anemia; Gastrointestinal Hemorrhage; Humans; Iron; Multicenter Studies as Topic; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome

Iron deficiency, with or without anemia, is an adverse prognostic factor in heart failure (HF). In AFFIRM-AHF (a randomized, double-blind placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalizations and mortality in iron-deficient subjects admitted for acute heart failure), intravenous ferric carboxymaltose (FCM), although having no significant effect on the primary end point, reduced the risk of HF hospitalization (hHF) and improved quality of life versus placebo in iron-deficient patients stabilized after an acute HF (AHF) episode. These prespecified AFFIRM-AHF subanalyses explored the association between hemoglobin levels and FCM treatment effects.. AFFIRM-AHF was a multicenter, double-blind, randomized, placebo-controlled trial of FCM in hospitalized AHF patients with iron deficiency. Patients were stratified by baseline hemoglobin level (<12 versus ≥12 g/dL). In each subgroup, the primary composite (total hHF and cardiovascular death) and secondary (total hHF; total cardiovascular hospitalizations and cardiovascular death; time to cardiovascular death, and time to first/days lost due to hHF or cardiovascular death) outcomes were assessed with FCM versus placebo at week 52. Sensitivity analyses using the World Health Organization anemia definition (hemoglobin level <12 g/dL [women] or <13 g/dL [men]) were performed, among others.. Of 1108 AFFIRM-AHF patients, 1107 were included in these subanalyses: 464 (FCM group, 228; placebo group, 236) had a hemoglobin level <12 g/dL, and 643 (FCM, 329; placebo, 314) had a hemoglobin level ≥12 g/dL. Patients with a hemoglobin level <12 g/dL were older (mean, 73.7 versus 69.1 years), with more frequent previous HF (75.0% versus 68.7%), serum ferritin <100 μg/L (75.4% versus 68.1%), and transferrin saturation <20% (87.9% versus 81.4%). For the primary outcome, annualized event rates per 100 patient-years with FCM versus placebo were 71.1 and 73.6 (rate ratio, 0.97 [95% CI, 0.66-1.41]), respectively, and 48.5 versus 72.9 (RR, 0.67 [95% CI, 0.48-0.93]) in the hemoglobin levels <12 and ≥12 g/dL subgroups, respectively. No significant interactions between hemoglobin subgroup and treatment effect were observed for primary (. The effects of intravenous FCM on outcomes in iron-deficient patients stabilized after an AHF episode, including improvements in iron parameters over time, did not differ between patients with hemoglobin levels <12 and ≥12 g/dL.. URL: https://www.. gov; Unique identifier: NCT02937454.

Topics: Anemia; Female; Ferric Compounds; Ferritins; Heart Failure; Hemoglobins; Humans; Iron; Iron Deficiencies; Male; Maltose; Quality of Life; Transferrins; Treatment Outcome

Anaemia affects 46% of pregnancies in Africa; oral iron is recommended by WHO but uptake and adherence are suboptimal. We tested a single dose of a modern intravenous iron formulation, ferric carboxymaltose, for anaemia treatment in Malawian pregnant women.. In this open-label, individually randomised controlled trial, we enrolled women with a singleton pregnancy of 13-26 weeks' gestation in primary care and outpatient settings across two regions in southern Malawi. Women were eligible if they had capillary haemoglobin of less than 10·0 g/dL and negative malaria rapid diagnostic test. Participants were randomised by sealed envelope 1:1. Assessors for efficacy outcomes (laboratory parameters and birthweight) were masked to intervention; participants and study nurses were not masked. Participants were given ferric carboxymaltose up to 1000 mg (given once at enrolment in an outpatient primary care setting), or standard of care (60 mg elemental iron twice daily for 90 days), along with intermittent preventive malaria treatment. The primary maternal outcome was anaemia at 36 weeks' gestation. The primary neonatal outcome was birthweight. Analyses were performed in the intention-to-treat population for mothers and liveborn neonates, according to their randomisation group. Safety outcomes included incidence of adverse events during infusion and all adverse events from randomisation to 4 weeks' post partum. The trial is registered with ANZCTR, ACTRN12618001268235. The trial has completed follow-up.. Between Nov 12, 2018, and March 2, 2021, 21 258 women were screened, and 862 randomly assigned to ferric carboxymaltose (n=430) or standard of care (n=432). Ferric carboxymaltose did not reduce anaemia prevalence at 36 weeks' gestation compared with standard of care (179 [52%] of 341 in the ferric carboxymaltose group vs 189 [57%] of 333 in the standard of care group; prevalence ratio [PR] 0·92, 95% CI 0·81 to 1·06; p=0·27). Anaemia prevalence was numerically lower in mothers randomly assigned to ferric carboxymaltose compared with standard of care at all timepoints, although significance was only observed at 4 weeks' post-treatment (PR 0·91 [0·85 to 0·97]). Birthweight did not differ between groups (mean difference -3·1 g [-75·0 to 68·9, p=0·93). There were no infusion-related serious adverse events or differences in adverse events by any organ class (including malaria; ≥1 adverse event: ferric carboxymaltose 183 [43%] of 430 vs standard of care 170 [39%] of 432; risk ratio 1·08 [0·92 to 1·27]; p=0·34).. In this malaria-endemic sub-Saharan African setting, treatment of anaemic pregnant women with ferric carboxymaltose was safe but did not reduce anaemia prevalence at 36 weeks' gestation or increase birthweight.. Bill & Melinda Gates Foundation (INV-010612).

Topics: Anemia; Anemia, Iron-Deficiency; Birth Weight; Female; Humans; Infant, Newborn; Iron; Malaria; Malawi; Pregnancy; Pregnancy Trimester, Second; Pregnant Women

Reducing the need for blood transfusion among patients undergoing cardiac surgery FLA reduce postoperative complications and mortality. Our study aimed to assess the effects of administering preoperative i.v. ferric carboxymaltose on postoperative red cell transfusion requirements in patients without anaemia undergoing on-pump cardiac surgery.. This double-blind, randomised, placebo-controlled trial was conducted between October 2016 and November 2019, with a follow-up period of up to 6 weeks after surgery. Patients without anaemia who underwent on-pump cardiac surgery were included as participants and administered i.v. iron in the form of ferric carboxymaltose or placebo once, 24-72 h before surgery. The primary outcome was the number of red cell units transfused during the first four postoperative days, and the secondary outcome measures were blood haemoglobin concentrations at 4 days and 6 weeks after surgery.. In patients without anaemia undergoing on-pump cardiac surgery, treatment with a single dose of 1000 mg ferric carboxymaltose i.v. 1-3 days before surgery significantly reduced the need for red cell transfusions and increased the postoperative haemoglobin concentration.. NCT02939794.

Topics: Administration, Intravenous; Anemia; Cardiac Surgical Procedures; Double-Blind Method; Erythrocyte Transfusion; Ferric Compounds; Hemoglobins; Humans; Iron; Maltose

Recent clinical guidelines suggest that treatment of postoperative anaemia in colorectal cancer surgery with intravenous iron reduces transfusion requirements and improves outcomes. The study aimed at comparing two intravenous iron regimens in anaemic patients after colorectal cancer surgery.. This was a single-centre, open-label, randomised, controlled trial in patients undergoing elective colorectal cancer surgery. Patients with moderate to severe anaemia (haemoglobin [Hb] <11 g/dL) after surgery were randomly assigned 1:1 to receive ferric carboxymaltose (FC; 1,000 mg, single dose) or iron sucrose (IS; 200 mg every 48 hours until covering the total iron deficit or discharge). Randomisation was stratified by Hb level: <10 g/dL (Group A) or ≥10-10.9 (Group B). The primary endpoint was the change in Hb concentration at postoperative day 30. Secondary endpoints included iron status parameters, transfusion requirements, complications, and length of hospital stay.. From September 2015 to May 2018, 104 patients were randomised (FC 50, IS 54). The median intravenous iron dose was 1,000 mg and 600 mg in the FC and IS groups, respectively. There were no between-group differences in mean change in Hb from postoperative day 1 to postoperative day 30 (FC: 2.5 g/dL, 95% CI: 2.1-2.9; IS: 2.4 g/dL, 95% CI: 2.0-2.8; p=0.52), in transfusion requirements or length of stay. The infection rate was lower in the FC group compared with the IS group (9.8% vs 37.2%, respectively).. The administration of approximately 500 mg of IS resulted in an increase in Hb at postoperative day 30 similar to that of 1,000 mg of FC, but it was associated with a higher infection rate. Future research will be needed to confirm the results, and to choose the best regime in terms of effectiveness and side effects to treat postoperative anaemia in colorectal cancer patients.

Topics: Administration, Intravenous; Anemia; Anemia, Iron-Deficiency; Colorectal Neoplasms; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Iron; Maltose

Anaemia is common and associated with poor outcomes in survivors of critical illness. However, the optimal treatment strategy is unclear.. We conducted a multicentre, feasibility RCT to compare either a single dose of ferric carboxymaltose 1000 mg i.v. or usual care in patients being discharged from the ICU with moderate or severe anaemia (haemoglobin ≤100 g L. A large, multicentre RCT of i.v. iron to treat anaemia in survivors of critical illness appears feasible and is necessary to determine the effects on patient-centred outcomes.. ISRCTN13721808 (www.isrctn.com).

Topics: Administration, Intravenous; Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Critical Care; Feasibility Studies; Female; Ferric Compounds; Follow-Up Studies; Hematinics; Hemoglobins; Humans; Length of Stay; Male; Maltose; Middle Aged; Patient Readmission; Patient Reported Outcome Measures; Young Adult

Radical abdominal surgery is part of the standard treatment for women with advanced gynaecological carcinoma. The surgery often leads to intraoperative blood loss frequently exceeding 1000 mL. Approximately 50% of women undergoing radical surgery require blood transfusions. Perioperative blood transfusions have been shown to increase the risk of postoperative complications, delayed wound healing, increased length of stay, increased postoperative morbidity and mortality. Previous studies have demonstrated an association between perioperative anaemia and surgical morbidity and mortality. By reducing transfusions and improving recovery from surgery, preoperative diagnostic and management of perioperative anaemia is a great opportunity to optimise postoperative patient outcome.. This is a single-blind, monocentre, randomised trial with four parallel groups (three therapeutic groups and one control group without treatment according to current standards of care) conducted in women undergoing radical gynaecological surgery. The primary study objective is to determine the effect of perioperative treatment with either intravenous iron, tranexamic acid or with a combination of both medicines on the reduction of intraoperative and postoperative red blood cell transfusions in gynaecological carcinoma patients. A total of N=126 women with gynaecological carcinoma will be recruited at the University Hospital Basel, Department of Gynaecology. Blood parameters will be measured at the recruitment, prior to surgery, 2 days after surgery and on the 21st-28th day after surgery. Recruitment started in August 2021.. The study will be performed according to the guidelines of the Declaration of Helsinki and is approved by the Ethics Committee for Northwest and Central Switzerland in Basel (EKNZ Protocol ID 2020-01194). The results of this study will be published and presented in various scientific forums.. NCT03792464.

Topics: Anemia; Blood Transfusion; Carcinoma; Female; Ferric Compounds; Gynecologic Surgical Procedures; Humans; Iron; Maltose; Randomized Controlled Trials as Topic; Single-Blind Method; Tranexamic Acid

Erythropoiesis-stimulating agents (ESA) are effective for chemotherapy-induced anemia (CIA) but associated with serious adverse events. Safer alternatives would be beneficial in this population. The efficacy and safety of ferric carboxymaltose (FCM) as monotherapy for CIA was evaluated. This Phase 3, 18-week, double-blind, placebo-controlled study randomized adults with ≥ 4 weeks of chemotherapy remaining for treatment of nonmyeloid malignancies with CIA to FCM (two 15 mg/kg infusions 7 days apart; maximum dose, 750 mg single/1500 mg total) or placebo. The primary efficacy endpoint was percentage of patients with decreases in hemoglobin (Hb) ≥ 0.5 g/dL from weeks 3 to 18; the key secondary efficacy endpoint was change in Hb from baseline to week 18. Inclusion criteria included: (Hb) 8-11 g/dL, ferritin 100-800 ng/mL, and transferrin saturation (TSAT) ≤35%. In 244 patients (n = 122, both groups), the percent of patients who maintained Hb within 0.5 g/dL of baseline from weeks 3 to 18 was significantly higher with FCM versus placebo (50.8% vs. 35.3%; p = 0.01). Mean change in Hb from baseline to week 18 was similar between FCM and placebo (1.04 vs. 0.87 g/dL) but significantly greater with FCM with baseline Hb ≤ 9.9 g/dL (1.08 vs. 0.42 g/dL; p = 0.01). The percent with ≥ 1 g/dL increase from baseline was significantly higher with FCM versus placebo (71% vs. 54%; p = 0.01), occurring in a median 43 versus 85 days (p = 0.001). Common adverse events in the FCM arm included neutropenia (17%), hypophosphatemia (16%), and fatigue (15%). FCM monotherapy effectively maintained Hb and was well tolerated in CIA.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Double-Blind Method; Female; Ferric Compounds; Humans; Induction Chemotherapy; Male; Maltose; Middle Aged; Neoplasms; Placebo Effect; Treatment Outcome

Anaemia in pregnancy remains a critical global health problem, affecting 46% of pregnant women in Africa and 49% in Asia. Oral iron therapy requires extended adherence to achieve correction of anaemia and replenishment of iron stores. Ferric carboxymaltose (FCM) is a recently established intravenous iron formulation associated with substantial advantages in safety, speed of delivery and total dose deliverable in a single infusion. We aim to determine whether FCM given once during the second trimester of pregnancy compared with standard oral iron distributed through routine antenatal services is effective and safe for treatment of moderate to severe maternal anaemia in sub-Saharan Africa.. The randomized controlled trial of the effect of intravenous iron on anaemia in Malawian pregnant women (REVAMP) is a two-arm confirmatory individually randomised trial set in Blantyre and Zomba districts in Malawi. The trial will randomise 862 women in the second trimester of pregnancy with a capillary haemoglobin concentration below 100.0 g/L. The study comprises two arms: (a) intravenous FCM (20 mg/kg up to 1000 mg) given once at randomisation, and (b) standard of care oral iron (65 mg elemental iron two times per day) for 90 days (or the duration of pregnancy, whichever is shorter) provided according to local healthcare practices. Both arms receive sulfadoxine-pyrimethamine as intermittent preventive treatment in pregnancy. The primary outcome is the prevalence of anaemia (Hb <110.0 g/L) at 36 weeks' gestation. Secondary outcomes include birth weight, gestation duration and safety outcomes, including clinical malaria, serious perinatal events and postpartum haematologic and health-related outcomes in the mother and child.. Ethical approval was granted by the Research Ethics Committee (COMREC P.02/18/2357) in Malawi and the Human Research Ethics Committee (WEHI: 18/02), Melbourne, Australia. The protocol is registered with the Australian and New Zealand Clinical Trials Registry. The results will be shared with the local community that enabled the research, and also to the international fora.. ACTRN12618001268235; Pre-results.

Topics: Anemia; Anemia, Iron-Deficiency; Australia; Female; Ferric Compounds; Humans; Malawi; Maltose; Multicenter Studies as Topic; Pregnancy; Pregnant Women; Randomized Controlled Trials as Topic; Standard of Care

Anemia is a recognized risk factor for perioperative related morbidity and mortality and is frequently reported in liver surgeries with an estimated incidence of 32%. We aim to assess the impact of intravenous iron administration in the immediate postoperative period on anemia and iron status as well as to determine the kinetics of hepcidin after liver surgery.. The HepciFer trial, a randomized controlled trial, included 50 patients undergoing liver surgery. In accordance with the randomization process, patients received either ferric carboxymaltose (15 mg/kg, maximum 1 g) or placebo 4 hours after surgery.. The mean hemoglobin level, 7 days after surgery, did not differ significantly between the intervention and control group (11.1 ± 1.8 g/dL and 10.4 ± 1.6 g/dL, respectively) with a mean difference of +0.7 g/dL ([95% confidence interval, -0.3 to +1.7], P = .173). Within patients receiving intravenous iron supplementation, none presented biological signs of functional iron deficiency. Hepcidin levels remained significantly higher during the observation period in the intervention group. Inflammatory biomarkers, red blood cells transfusion rate and hospital duration of stay were similar between groups.. Intravenous ferric carboxymaltose administration did not result in a significant increase of hemoglobin levels 7 days after surgery. However, this study suggests that intravenous iron supplementation in the immediate postoperative settings prevents functional iron deficiency. Intravenous iron supplementation overcame the hepcidin-mediated blockade of iron absorption and should be considered as the preferred route of administration in the postoperative period.

Topics: Aged; Anemia; C-Reactive Protein; Ferric Compounds; Ferritins; Hepatectomy; Hepcidins; Humans; Infusions, Intravenous; Interleukin-6; Iron; Male; Maltose; Postoperative Care; Postoperative Complications

Preoperative anaemia is highly prevalent among patients scheduled for total hip arthroplasty (THA), and is the main risk factor for perioperative red blood cell transfusion (RBCT). This retrospective cohort study aimed at assessing whether preoperative haemoglobin (Hb) optimisation reduced RBCT rates and improved outcome in this patient population.. All patients entered a Patient Blood Management (PBM) programme consisting of in-hospital erythropoiesis stimulation, tranexamic acid administration, and a restrictive RBCT policy. Data from preoperatively anaemic patients (Hb <13 g/dL) who underwent THA, before (2015-2016, control group, n=75) or after (2017-2018, study group, n=70) the incorporation of a preoperative Hb optimisation protocol (Ferric carboxymaltose IV, 1,000 mg ± epoetin-α, 40,000 IU; administered 4 weeks prior to surgery) to the PBM programme underwent a comparative analysis.. Haemoglobin concentrations at preoperative assessment were similar (12.1±0.7 g/dL vs 12.2±0.7 g/dL, for study and control groups, respectively; p=0.129). At hospital admission, significantly higher Hb were observed in the study group (13.4±0.8 g/dL vs 12.2±0.7 g/dL, respectively; p=0.001), with anaemia being corrected in 79% of cases. Compared to the control group, reduced perioperative RBCT rate (4% vs 24%, respectively; p=0.001), shorter length of hospital stay (6 [range 5-7] days vs 7 [5-8 days], respectively; p=0.002), and increased proportion of patients being discharged directly to their home (74% vs 47%, respectively; p=0.01) were observed in the study group. No treatment-related side-effects were witnessed.. Within a PBM programme for THA, preoperative Hb optimisation was efficacious at correcting anaemia and minimising RBCT requirements, thus contributing to an improvement in postoperative outcomes.

Topics: Aged; Aged, 80 and over; Anemia; Arthroplasty, Replacement, Hip; Elective Surgical Procedures; Erythrocyte Transfusion; Female; Ferric Compounds; Hemoglobins; Humans; Length of Stay; Male; Maltose; Middle Aged; Retrospective Studies

Anemia is the most common and serious cancer-related complication. This study aimed to evaluate the efficacy of administration of ferric carboxymaltose without erythropoiesis-stimulating agents for treating anemia in cancer patients. Moreover, we identified the biomarkers of hemoglobin response to predict the need for iron therapy.. We enrolled patients with solid cancers who were treated at a single institute (Samsung Medical Center, South Korea), from April 2015 to July 2017, in this prospective single-arm Phase II clinical trial. Patients received intravenous ferric carboxymaltose (1,000 mg) infusion on the first day (visit 1) of treatment. The primary end point was the number of hemoglobin responders, defined as patients with an increase in hemoglobin level ≥ 1.0 g/dL from the baseline, a hemoglobin level ≥ 11.0 g/dL, or both, within an 8-week observation period (week 3, 6, or 8). Secondary end points included changes in transferrin saturation and levels of soluble transferrin receptors, hepcidin, erythropoietin, interleukin-6, and C-reactive protein (CRP) at each visit. Of the 103 recruited patients, 92 were eligible for analysis. The mean patient age was 57.3 ± 12.5 years, and 54.3% of the patients were women. The most common diagnoses were breast cancer (n = 23, 25.1%), lung cancer (n = 21, 22.9%), gastrointestinal cancer (n = 20, 20.9%), and lymphoma (n = 16, 17.7%). A hemoglobin response was observed in 36 (39.1%), 53 (57.6%), and 61 (66.3%) patients in the third, fifth, and eighth weeks, respectively. The mean increase in hemoglobin levels from the baseline to the end of treatment was 1.77 ± 1.30 g/dL. Baseline values of hepcidin (p = 0.008), total iron binding capacity (p = 0.014), ferritin (p = 0.048), and CRP (p = 0.044) were significantly different between the responder and nonresponder groups. Multiple logistic regression analysis for baseline anemia-related biochemical variable significantly associated with the hemoglobin response showed that only baseline hepcidin level was a significant factor for hemoglobin response (odds ratio = 0.95, 95% confidence interval 0.90-1.0, p = 0.045). Hemoglobin responders had significantly lower hepcidin levels than nonresponders (mean [±standard deviation], 13.45 [±14.71] versus 35.22 [±40.470 ng/ml]; p = 0.007). However, our analysis had some limitations such as the different patient characteristics in the studies that were included, institutional differences in the measurement of hepcidin level, and missing data on long-term safety. Therefore, our findings need further validation.. Intravenous ferric carboxymaltose (1,000 mg) monotherapy increases hemoglobin levels without serious adverse events in patients with cancer. Hepcidin is a useful biomarker for predicting iron requirement in cancer patients.. Clinicaltrials.gov NCT02599012.

Topics: Anemia; Antineoplastic Agents; Biomarkers; Erythropoietin; Female; Ferric Compounds; Hemoglobins; Hepcidins; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Neoplasms; Pilot Projects; Republic of Korea; Transferrin; Treatment Outcome

Patients with colorectal cancer (CRC) often present with associated anaemia which is usually present at the time of diagnosis and is aggravated during the postoperative period due to blood loss during the surgery process. Several guidelines advocate for the treatment of postoperative anaemia in these patients in order to prevent complications and allogeneic blood transfusions. However, there are no publications to shed light on the effectiveness of intravenous iron (IVI) administration after CRC surgery and the optimal dose and regimen. We have started a clinical trial with the objective of comparing the effectiveness of 1000 mg of ferric carboxymaltose with fractionated iron sucrose 200 g/48 h for the treatment of postoperative anaemia, by measuring the change of haemoglobin (Hb) levels from postoperative day (POD) 1 to POD 30.. We designed an open label randomised controlled trial to compare two postoperative IVI treatment regimens. Patients aged > 18 years undergoing CRC surgery, with Hb < 11 g/dL on POD 1 are randomly assigned to receive either 1000 mg of ferric carboxymaltose (single dose) or 200 g/48 h of iron sucrose. The main study endpoint will be the change from POD 1 to POD 30 in Hb levels and the key secondary endpoint the percentage of patients with Hb levels ≥ 13 g/dL at POD 30. Other secondary endpoints include: changes in iron metabolism parameters (Fe, ferritin, transferrin, % saturated trasferrin) at POD 30; total doses of iron received; number of postoperative transfusions; compliance with oral iron treatment; number of medical and surgical complications; adverse reactions reported by the patient; use of health resources after surgery; and changes in quality of life (QoL). It has been estimated that a sample of 48 patients per group will allow detecting a difference of 0.75 g/dL in Hb in the change in Hb levels from POD 1 to POD 30.. The results of this study will confirm if the single dose of 1000 mg ferric carboxymaltose should be preferred in front of the fractionated doses and in which type of patients this regimen should be used preferably.. European Union Clinical Trials Register, EudraCT 2015-001005-13 . Registered on 6 January 2015.

Topics: Anemia; Colorectal Neoplasms; Ferric Compounds; Ferric Oxide, Saccharated; Humans; Infusions, Intravenous; Maltose; Postoperative Complications; Randomized Controlled Trials as Topic

Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes.. To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy.. The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea. Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included.. Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients).. The primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life at weeks 3 and 12.. Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group.. Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks.. clinicaltrials.gov Identifier: NCT01725789.

Topics: Adult; Aged; Anemia; Female; Ferric Compounds; Gastrectomy; Hematinics; Hemoglobins; Humans; Injections; Male; Maltose; Middle Aged; Postoperative Complications; Single-Blind Method

Clinical status in heart failure is conventionally assessed by the physician's evaluation, patients' own perception of their symptoms, quality of life (QoL) tools, and a measure of functional capacity. These aspects can be measured with tools such as the New York Heart Association functional class, QoL tools such as the EuropeanQoL-5 dimension, the Kansas City Cardiomyopathy Questionnaire, patient global assessment (PGA), and by 6-minute walk test (6MWT), respectively. The ferric carboxymaltose in patients with heart failure and iron deficiency (FAIR-HF) trial demonstrated that treatment with intravenous ferric carboxymaltose in iron-deficient patients with symptomatic heart failure with reduced left ventricular function, significantly improved all 5 outcome measures. This analysis assessed the correlations between the longitudinal changes in the measures of clinical status, as measured by QoL tools and the changes in the measures of functional capacity as measured by the 6MWT. This analysis used the database from the FAIR-HF trial, which randomized 459 patients with chronic heart failure (reduced left ventricular ejection fraction) and iron deficiency, with or without anemia to ferrous carboxymaltose or placebo. The degree of correlation between QoL tools and the 6MWT was assessed at 4, 12, and 24 weeks. The data demonstrate highly significant correlations between QoL and functional capacity, as measured by the 6MWT, at all time points (p <0.001). Changes in PGA, Kansas City Cardiomyopathy Questionnaire, and EuroQoL-5D correlated increasingly over time with changes in 6MWT performance. Interestingly, the strongest correlation at 24 weeks is for the PGA, which is a simple numerical scale (r = -0.57, p <0.001). This analysis provides evidence that QoL assessment show a significant correlation with functional capacity, as measured by the 6MWT. The strength of these correlations increased over time.

Topics: Aged; Anemia; Exercise Test; Exercise Tolerance; Female; Ferric Compounds; Follow-Up Studies; Heart Failure; Hematinics; Humans; Longitudinal Studies; Male; Maltose; Middle Aged; Quality of Life; Recovery of Function; Self Report; Treatment Outcome

The increasing incidence of osteoporotic hip fracture (HF) has raised the requirements of red blood cell (RBC) transfusions, whereas this scarce resource may cause morbidity and mortality.. This study was a multicenter, randomized, double-blind, clinical trial that aimed to assess efficacy of ferric carboxymaltose (FCM) with or without erythropoietin (EPO) in reducing RBC transfusion in the perioperative period of HF. Participants (patients > 65 years admitted with HF and hemoglobin [Hb] levels of 90-120 g/L) were randomly assigned to receive a preoperative single dose of 1 g of FCM (short intravenous [IV] infusion over 15 min), plus 40,000 IU of subcutaneous EPO (EPOFE arm); versus 1 g of IV FCM plus subcutaneous placebo (FE arm); and versus IV and subcutaneous placebo (placebo arm). Primary endpoint was the percentage of patients who received RBC transfusion, and secondary endpoints were the number of RBC transfusions per patient, survival, hemoglobinemia, and health-related quality of life (HRQoL; by means of Short Form 36 Version 2 questionnaire).. A total of 306 patients (85% women, mean age 83 ± 6.5 years) were included. A total of 52, 51.5, and 54% of patients required RBC transfusion in the EPOFE, FE, and placebo arms, respectively, with no significant differences in the number of RBC transfusions per patient, survival, HRQoL, and adverse events among treatment groups. A significant increase in Hb levels was achieved at discharge (102 g/L vs. 97 g/L) and 60 days after discharge (125 g/L vs. 119 g/L) in the EPOFE arm with respect to placebo arm; in addition, a higher rate of patients recovered from anemia in the EPOFE arm with respect to the placebo arm (52% vs. 39%), 60 days after discharge.. Preoperative treatment with FCM alone or in combination with EPO improved recovery from postoperative anemia, but did not reduce the needs of RBC transfusion in patients with HF.

Topics: Aged; Aged, 80 and over; Anemia; Double-Blind Method; Erythrocyte Transfusion; Erythropoietin; Female; Ferric Compounds; Hip Fractures; Humans; Male; Maltose; Quality of Life; Treatment Outcome

Both anaemia and allogenic red blood cell transfusion are common and potentially harmful in patients admitted to the intensive care unit. Whilst intravenous iron may decrease anaemia and RBC transfusion requirement, the safety and efficacy of administering iron intravenously to critically ill patients is uncertain.. The multicentre, randomized, placebo-controlled, blinded Intravenous Iron or Placebo for Anaemia in Intensive Care (IRONMAN) study was designed to test the hypothesis that, in anaemic critically ill patients admitted to the intensive care unit, early administration of intravenous iron, compared with placebo, reduces allogeneic red blood cell transfusion during hospital stay and increases the haemoglobin level at the time of hospital discharge.. Of 140 patients enrolled, 70 were assigned to intravenous iron and 70 to placebo. The iron group received 97 red blood cell units versus 136 red blood cell units in the placebo group, yielding an incidence rate ratio of 0.71 [95 % confidence interval (0.43-1.18), P = 0.19]. Overall, median haemoglobin at hospital discharge was significantly higher in the intravenous iron group than in the placebo group [107 (interquartile ratio IQR 97-115) vs. 100 g/L (IQR 89-111), P = 0.02]. There was no significant difference between the groups in any safety outcome.. In patients admitted to the intensive care unit who were anaemic, intravenous iron, compared with placebo, did not result in a significant lowering of red blood cell transfusion requirement during hospital stay. Patients who received intravenous iron had a significantly higher haemoglobin concentration at hospital discharge. The trial was registered at http://www.anzctr.org.au as # ACTRN12612001249842.

Topics: Administration, Intravenous; Adult; Aged; Allografts; Anemia; Confidence Intervals; Critical Illness; Double-Blind Method; Erythrocyte Transfusion; Female; Ferric Compounds; Hemoglobins; Humans; Intensive Care Units; Intention to Treat Analysis; Male; Maltose; Middle Aged

Anaemia is common in patients undergoing major surgery. The current standard of care for patients with low haemoglobin in the peri-operative period is blood transfusion. The presence of preoperative anaemia is associated with an increased likelihood of the patient receiving peri-operative transfusion and worsened outcomes following surgery, more post-operative complications, delayed recovery and greater length of hospital stay. Intravenous iron, if applied in the preoperative setting, may correct anaemia by the time of surgery and reduce the need for blood transfusion and improve outcomes.. PREVENTT is a phase III double-blind randomised controlled trial that will compare the use of intravenous ferric carboxymaltose (dose 1000 mg) with placebo 10-42 days before major open abdominal surgery in 500 patients with anaemia (haemoglobin < 120 g/L). The primary outcome measure will be the need for blood transfusion and secondary endpoints will include post-operative recovery, length of hospital stay, health care utilisation and cost analysis.. ISRCTN67322816--registered 9 October 2012. ClinicalTrials.gov identifier: NCT01692418.

Topics: Abdomen; Administration, Intravenous; Anemia; Biomarkers; Blood Transfusion; Clinical Protocols; Cost-Benefit Analysis; Double-Blind Method; Drug Costs; England; Ferric Compounds; Health Resources; Hematinics; Hemoglobins; Hospital Costs; Humans; Length of Stay; Maltose; Preoperative Care; Recovery of Function; Research Design; Time Factors; Treatment Outcome

Isovolemic anemia (decrease in hemoglobin concentration with normal or even increased blood volume) after gastric cancer surgery may negatively influence short- and long-term outcomes. Therefore correction of isovolemic postoperative anemia is supposed to be beneficial. This prospective randomized placebo-controlled multicenter trial is designed to evaluate the efficacy of ferric carboxymaltose administration with the primary end point of successful hemoglobin level increase by 2 g/dl at 12 weeks after randomization.. Gastric cancer patients after oncologic resection and postoperative hemoglobin level ≥ 7 g/dl to <10 g/dl at postoperative days 5 to 7 will be eligible for trial inclusion. After randomization, 450 patients (225 per group) are going to be subjected either to administration of ferric carboxymaltose (treatment group) or normal (0.9%) saline (placebo group). Patients will be blinded to the intervention. Patients will undergo evaluation for hemoglobin level, hematology and quality of life assessment 3 and 12 weeks after randomization.. Correction of isovolemic postoperative anemia in gastric cancer patients after oncologic resection is considered to be beneficial. Administration of ferric carboxymaltose is considered to be superior to placebo for anemia correction without the possible risks of red blood cell transfusion. Further, improved quality of life for patients with quick recovery of hemoglobin levels is expected.. NCT01725789 (international: http://www.clinicaltrials.gov) and NCCCTS-12-644 (NCC, Korea).

Topics: Anemia; Biomarkers; Blood Volume; Clinical Protocols; Female; Ferric Compounds; Gastrectomy; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Male; Maltose; Quality of Life; Republic of Korea; Research Design; Stomach Neoplasms; Time Factors; Treatment Outcome

Despite preoperative anaemia treatment, a risk of postoperative anaemia remains. This randomized, controlled study evaluated the efficacy of i.v. ferric carboxymaltose (FCM) as postoperative anaemia treatment after total knee arthroplasty (TKA).. TKA patients with postoperative anaemia [haemoglobin (Hb) 8.5-12.0 g dl(-1)] without prior transfusions were randomly assigned to FCM [700-1000 mg iron (according to calculate iron deficit on postoperative day 2)] or ferrous glycine sulphate (FS; 100 mg iron daily from day 7 onwards) and followed for Hb, iron status, quality-of-life (EQ-5D), and performance (6 min walk test) until day 30.. Of 161 preoperatively non-anaemic patients, 122 (75.8%) developed anaemia after operation (within 24 h) and were enrolled in this study (60 FCM, 62 FS). Hb substantially decreased until day 4 in both groups, and partly recovered by day 30. FCM-treated patients achieved Hb ≥12.0 g dl(-1) more frequently (42.3% vs 23.5%; P=0.04) and showed a trend towards higher Hb increase from day 4 to day 30 [+1.7 (1.2) vs +1.3 (1.0); P=0.075] compared with FS-treated patients. Patients with postoperative Hb <10 g dl(-1) experienced better Hb increase with FCM [+2.4 (0.3) g dl(-1)] than FS [+1.1 (0.4) g dl(-1); P=0.018]. Patients being iron-deficient at enrolment (56.7%) had a higher Hb increase with FCM [+1.9 (0.3) g dl(-1)] than FS [+1.2 (0.2) g dl(-1); P=0.03]. Total EQ-5D and performance outcomes were comparable between the groups, but FCM was associated with better scores for 'usual activities'. No i.v. iron-related adverse events were reported.. Preoperatively non-anaemic TKA patients are at high risk of postoperative anaemia. Postoperative i.v. FCM provided significant benefit over oral FS, particularly in patients with preoperative iron deficiency, severe postoperative anaemia, or both.. EudraCT 2010-023038-22; ClinicalTrials.gov NCT01913808.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Anemia; Arthroplasty, Replacement, Knee; Female; Ferric Compounds; Ferrous Compounds; Glycine; Humans; Male; Maltose; Middle Aged; Postoperative Complications; Prospective Studies; Single-Blind Method; Spain; Treatment Outcome

The study aimed to analyse the feasibility and efficacy of administration of a single intravenous iron infusion (IVI) in the preoperative optimization of colorectal cancer patients with anaemia.. Twenty patients were recruited at least 14 days before the planned date of surgery. A single 1000 mg dose of ferric carboxymaltose (Ferinject) was administered as an outpatient procedure. Blood samples were taken at recruitment prior to drug administration (REC), on the day of surgery prior to any intervention (DOS) and on the first postoperative day. Allogeneic red blood cell transfusions (ARBT) and outcomes were recorded from recruitment throughout the study period.. There was a significant median rise in haemoglobin levels (Hb) from REC to DOS of 1.8 g/dl [interquartile range (IQR) 0.75-2.45, P < 0.001] for the entire cohort. Two patients received ARBT preoperatively, and for those not transfused preoperatively (n = 18), this incremental Hb rise remained significant (P < 0.001, median 1.65 g/dl, IQR 0.5-2.3). Of these patients, those who responded to IVI had higher erythropoietin (EPO) levels at recruitment (P < 0.01) and lower recruitment Hb values, transferrin-saturation (TSAT) and C-reactive protein (CRP) levels (P < 0.05). REC Hb (Rs = -0.62, P < 0.01), REC TSAT levels (Rs = -0.67, P < 0.01) and REC EPO (Rs = 0.69, P < 0.01) correlated with the magnitude of treatment change in Hb levels. Five patients received ARBT until the fourth postoperative day, which was significantly fewer than predicted (P < 0.05).. IVI can be administered preoperatively in the outpatient clinic to colorectal cancer patients with anaemia, with associated reduction in ARBT use and increase in Hb levels.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Anemia; C-Reactive Protein; Colorectal Neoplasms; Erythrocyte Transfusion; Erythropoietin; Feasibility Studies; Female; Ferric Compounds; Hemoglobins; Humans; Infusions, Intravenous; Length of Stay; Male; Maltose; Middle Aged; Pilot Projects; Postoperative Complications; Preoperative Care; Transferrins

This randomized trial evaluated ferric carboxymaltose without erythropoiesis-stimulating agents (ESA) for correction of anemia in cancer patients with functional iron deficiency. Patients on treatment for indolent lymphoid malignancies, who had anemia [hemoglobin (Hb) 8.5-10.5 g/dL] and functional iron deficiency [transferrin saturation (TSAT) ≤ 20%, ferritin >30 ng/mL (women) or >40 ng/mL (men)], were randomized to ferric carboxymaltose (1,000 mg iron) or control. Primary end point was the mean change in Hb from baseline to weeks 4, 6 and 8 without transfusions or ESA. Difficulties with patient recruitment led to premature termination of the study. Seventeen patients (8 ferric carboxymaltose and 9 control) were included in the analysis. In the ferric carboxymaltose arm, mean Hb increase was significantly higher versus control at week 8 (p = 0.021). All ferric carboxymaltose-treated patients achieved an Hb increase >1 g/dL (control 6/9; p = 0.087), and mean TSAT was >20% from week 2 onwards. No treatment-related adverse events were reported. In conclusion, ferric carboxymaltose without ESA effectively increased Hb and iron status in this small patient population.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Anemia, Iron-Deficiency; Antineoplastic Agents; Female; Ferric Compounds; Hemoglobins; Humans; Injections, Intravenous; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Male; Maltose; Middle Aged; Multiple Myeloma; Treatment Outcome

Allogeneic red blood cell (RBC) transfusion is associated with significant increases in mortality and major morbidity in patients admitted to the intensive care unit, and the blood supplies it requires are an increasingly scarce and costly resource. Despite high levels of compliance with recommended transfusion thresholds in the ICU, RBC transfusion remains common. Novel interventions to reduce the incidence of RBC transfusion are required.. To describe the study protocol for a randomised controlled trial, the Intravenous Iron or Placebo for Anaemia in Intensive Care (IRONMAN) trial, comparing intravenous (IV) iron with placebo in patients who are admitted to an ICU and are anaemic.. A Phase IIb multicentre, randomised, placebo-controlled trial. Patients admitted to the ICU with a haemoglobin (Hb) level < 100 g/L and predicted to require critical care beyond the next calendar day will be randomly assigned in a 1 : 1 ratio to receive IV ferric carboxymaltose (500 mg) or placebo.. The primary end point will be the mean number of RBC units transfused from study enrolment to discharge from hospital. Secondary end points will include change in Hb level and incidence of nosocomial infection.. The IRONMAN trial is designed to determine whether IV iron administered to patients admitted to an ICU and who are anaemic is associated with a reduction in RBC transfusion, compared with placebo in addition to standard care. The results of this trial may determine whether a Phase III trial of IV iron in ICUs is feasible.. Australian New Zealand Clinical Trials Registry (ACTRN12612001249842).

Topics: Anemia; Clinical Protocols; Critical Care; Ferric Compounds; Infusions, Intravenous; Maltose; Research Design

Around one third to one half of patients with hip fractures require red-cell pack transfusion. The increasing incidence of hip fracture has also raised the need for this scarce resource. Additionally, red-cell pack transfusions are not without complications which may involve excessive morbidity and mortality. This makes it necessary to develop blood-saving strategies. Our objective was to assess safety, efficacy, and cost-effictveness of combined treatment of i.v. ferric carboxymaltose and erythropoietin (EPOFE arm) versus i.v. ferric carboxymaltose (FE arm) versus a placebo (PLACEBO arm) in reducing the percentage of patients who receive blood transfusions, as well as mortality in the perioperative period of hip fracture intervention.. Multicentric, phase III, randomized, controlled, double blinded, parallel groups clinical trial. Patients > 65 years admitted to hospital with a hip fracture will be eligible to participate. Patients will be treated with either a single dosage of i.v. ferric carboxymaltose of 1 g and subcutaneous erythropoietin (40.000 IU), or i.v. ferric carboxymaltose and subcutaneous placebo, or i.v. placebo and subcutaneous placebo. Follow-up will be performed until 60 days after discharge, assessing transfusion needs, morbidity, mortality, safety, costs, and health-related quality of life. Intention to treat, as well as per protocol, and incremental cost-effectiveness analysis will be performed. The number of recruited patients per arm is set at 102, a total of 306 patients.. We think that this trial will contribute to the knowledge about the safety and efficacy of ferric carboxymaltose with/without erythropoietin in preventing red-cell pack transfusions in patients with hip fracture. CLINICALTRIALS.GOV IDENTIFIER: NCT01154491.

Topics: Aged; Aged, 80 and over; Anemia; Combined Modality Therapy; Double-Blind Method; Drug Therapy, Combination; Erythrocyte Transfusion; Erythropoietin; Female; Ferric Compounds; Hip Fractures; Humans; Male; Maltose; Osteoporotic Fractures; Postoperative Hemorrhage; Research Design; Treatment Outcome

Anaemia due to chronic kidney disease (CKD) is common and may be managed with erythropoiesis stimulating agents and/or iron preparations. Iron preparations may be administered orally, intravenously or by intramuscular injection. Oral preparations pose a significant tablet burden on patients who are often taking multiple medications and may have undesirable gastrointestinal side effects. The existing intravenous preparation Venofer requires multiple doses of drug (typically 100-200 mg) at multiple clinic visits. The preparation Cosmofer may be given as a single dose, but this requires four to six hours to administer. For these reasons, their use in pre-dialysis patients remains limited in practice. The new intravenous iron preparation Ferric Carboxymaltose (Ferinject) may be given as a single dose of up to 1000 mg (but not exceeding 15 mg/kg/week) as an infusion over 6-15 minutes. This offers a significant advance in the management of these patients. We describe our initial experience with using this drug in a non-dialysis patient population with chronic kidney disease.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Female; Ferric Compounds; Hematinics; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Premedication; Renal Dialysis; Renal Insufficiency, Chronic

To estimate efficacy of rapid, large-dose intravenous (IV) administration of ferric carboxymaltose compared with oral iron therapy in anemic postpartum women.. In a randomized, controlled trial, we assigned anemic women (hemoglobin [Hb] less than or equal to 10 g/dL) within 10 days postpartum to receive either IV ferric carboxymaltose (less than or equal to 1,000 mg over 15 minutes, repeated weekly to achieve a total calculated replacement dose) or ferrous sulfate (FeSO(4)) 325 mg orally thrice daily for 6 weeks.. One hundred seventy-four patients received 350 IV doses of ferric carboxymaltose (mean total dose 1,403.1 mg) in 3, 2, or 1 injection (10.9%, 79.3%, or 9.8% of patients, respectively); 178 received FeSO(4). Patients assigned to IV ferric carboxymaltose compared with those assigned to oral iron achieved a Hb rise greater than or equal to 2.0 g/dL earlier (7.0 compared with 14.0 days, P<.001), were more likely to achieve a Hb rise greater than or equal to 3.0 g/dL at any time (86.3% compared with 60.4%, P<.001), and were more likely to achieve a Hb greater than 12.0 g/dL (90.5% compared with 68.6%, P<.001). A similar proportion of patients achieved a Hb rise greater than or equal to 2.0 g/dL (96.4% compared with 94.1%, IV compared with oral, P=.443). There were no serious adverse drug reactions.. Large-dose IV ferric carboxymaltose administration is a new iron agent that is effective for the treatment of postpartum anemia. When compared with oral ferrous sulfate, IV ferric carboxymaltose is better tolerated, prompts a more rapid Hb response, and corrects anemia more reliably.. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00396292. I.

Topics: Administration, Oral; Adult; Anemia; Dietary Supplements; Drug Administration Schedule; Female; Ferric Compounds; Ferrous Compounds; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Maltose; Mexico; Postpartum Period; Pregnancy; United States

Gynecological pathologies are an important cause of anemia in women. In this study, we aimed to evaluate women who had been hospitalized because of anemia (Hb level <10 g/dL) caused by gynecologic pathologies and treated with either intravenous iron (ferric carboxymaltose) or blood transfusion.. This retrospective cross-sectional study was performed in a tertiary care center. Women who were hospitalized with the diagnosis of anemia with Hb level<10 g/dL and abnormal uterine bleeding between March 2015- September 2017 in the gynecology clinic were enrolled in the study. Hemoglobin levels, hemoglobin changes, uterine pathology and treatment of patients were recorded and compared.. One hundred and fifteen women received red blood cell transfusion and 100 women were treated with intravenous ferric carboxymaltose. The mean age of the women was 45.1±6.1 (22-57) years. Although the mean Hb levels were higher in the iv-iron replacement group at the end of the one month (P=0.001), the mean increase in Hb levels was similar between two treatment modalities (P=0.101). Among the anemic women who required surgery, iv iron replacement was the first choice in 75.9% of women; 34.1% received red blood cell transfusion in the preoperative period.. Gynecological pathologies are a common cause of anemia in reproductive age women and intravenous carboxymaltose treatment is a safe and cheaper alternative of blood-transfusion in appropriate cases to elevate the Hb levels in the preoperative period.

Topics: Adult; Anemia; Blood Transfusion; Cross-Sectional Studies; Female; Ferric Compounds; Hematinics; Hemoglobins; Humans; Iron; Middle Aged; Retrospective Studies

Iron deficiency anemia in children is a public health problem. Although oral iron treatment is the first choice, common side effects and compliance problems can cause the treatment to be interrupted. This study retrospectively evaluated children treated with intravenous (IV) iron sucrose or ferric carboxymaltose (FCM) and compared the treatment processes and efficacy. The demographic characteristics and treatment details of the 44 children with iron deficiency anemia were retrospectively evaluated. Iron sucrose was administered to 25 patients and FCM was administered to 19 patients. The IV iron infusion was applied to 64% of the patients because of unresponsiveness to oral treatment, 25% of the patients because of compliance problems, and 11% of the patients because of severe anemia. IV iron therapy increased hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin, red-cell distribution width, and serum ferritin levels and decreased platelet count. The mean number of infusions per patient in the FCM group was lower, and the total treatment time was shorter. In conclusion, IV iron sucrose or FCM can be used in children with nonadherence to oral therapy and severe anemia in addition to specific indications.

Topics: Administration, Intravenous; Anemia; Anemia, Iron-Deficiency; Child; Ferric Compounds; Ferric Oxide, Saccharated; Humans; Infusions, Intravenous; Iron; Retrospective Studies

Topics: Adult; Anemia; Epidermolysis Bullosa; Ferric Compounds; Humans; Retrospective Studies

Preoperative intravenous iron administration is a frequently used patient blood management procedure. If the timeframe of intravenous iron administration before surgery is short, (1) the concentration of the intravenous iron compound might still be high in patients' plasma when undergoing surgery and (2) this iron in patients' plasma is at risk to be lost due to blood loss. The aim of the current study was, therefore, to track the iron compound ferric carboxymaltose (FCM) before, during, and after cardiac surgery requiring cardiopulmonary bypass, with an emphasis on intraoperative iron losses in shed blood and potential recovery through autologous cell salvage.. Concentrations of FCM were analyzed in patients' blood using a hyphenation of liquid chromatography and inductively coupled plasma-mass spectrometry to distinguish between pharmaceutical compound FCM and serum iron. In this prospective, single-center pilot trial, 13 anemic and 10 control patients were included. Anemic patients with hemoglobin levels ≤12/13 g/dL in women and men were treated with 500 milligrams (mg) intravenous FCM 12 to 96 hours before elective on-pump cardiac surgery. Patients' blood samples were collected before surgery and at days 0, 1, 3, and 7 after surgery. One sample each was taken of the cardiopulmonary bypass, the autologous red blood cell concentrate generated by cell salvage, and the cell salvage disposal bag.. Patients who had received FCM <48 hours before surgery had higher FCM serum levels (median [Q1-Q3], 52.9 [13.0-91.6]) compared to ≥48 hours (2.1 [0.7-5.1] µg/mL, P = .008). Of 500-mg FCM administered <48 hours, 327.37 (257.96-402.48) mg were incorporated compared to administration ≥48 hours with 493.60 (487.78-496.70) mg. After surgery, patients' plasma FCM concentration in the FCM <48 hours group was decreased (-27.1 [-30 to -5.9] µg/mL). Little FCM was found in the cell salvage disposal bag (<48 hours, 4.2 [3.0-25.8] µg/mL, equivalent to 29.0 [19.0-40.7] mg total; equivalent to 5.8% or 1/17th of the 500 mg FCM initially administered), almost none in the autologous red blood cell concentrate (<48 hours, 0.1 [0.0-0.43] µg/mL).. The data generate the hypotheses that nearly all FCM is incorporated into iron stores with administration ≥48 hours before surgery. When FCM is given <48 hours of surgery, the majority is incorporated into iron stores by the time of surgery, although a small amount may be lost during surgical bleeding with limited recovery by cell salvage.

Topics: Administration, Intravenous; Anemia; Cardiac Surgical Procedures; Female; Ferric Compounds; Humans; Iron; Male; Maltose; Pilot Projects; Prospective Studies

Among cardio-surgical patients, the prevalence of iron deficiency conditions reaches 70 %, and anemia is detected in less than 50% cases. Meanwhile, both anemia and latent iron deficiency are risk factors for adverse outcomes in cardio-surgical patients. These conditions are associated with a high frequency and greater volume of blood transfusions as well as with a longer stay in the hospital. Timely diagnosis and correction of iron deficiency, regardless of the presence of anemia, are mandatory at the stage of preoperative preparation. The use of oral iron medicines is limited by their low efficacy in this category of patients and a high risk of adverse events. Intravenous iron medicines have a high potential for correcting iron deficiency, and their efficacy and safety have been previously demonstrated. Administration of ferric carboxymaltose has proved beneficial in studies on iron deficiency correction in cardiological and cardio-surgical patients. In these patients, ferric carboxymaltose improved the dynamics of ferritin and hemoglobin, reduced the risk of blood transfusion, and decreased the duration of stay in the hospital. Preoperative intravenous administration of ferric carboxymaltose to cardio-surgical patients can improve clinical outcomes and the cost effectiveness of cardiac surgery.

Topics: Administration, Intravenous; Anemia; Anemia, Iron-Deficiency; Cardiac Surgical Procedures; Hemoglobins; Humans; Iron; Iron Deficiencies

Anemia remains an essential concern affecting the quality of life and the survival of cancer patients. Although there are different approaches to treating anemia in cancer patients, the number of studies reporting the efficacy of iron replacement in cancer patients is limited. In this study, the efficacy and safety of iron carboxymaltose, a parenteral iron treatment option, in the treatment of anemia, were examined retrospectively. A total of 1102 adult patients who received IV ferric carboxymaltose treatment at Hacettepe Oncology Hospital between 2014 and 2020 were included. The mean hemoglobin change observed at the end of the 12th week was 1.8 g/dL, and the rate of patients with an increase in hemoglobin of 1 g/dL or more was 72.1%. It was observed that the treatment demonstrated effectiveness in patients receiving active cancer treatment in all tumor types. The treatment was generally safe, and no grade 3-5 side effects were observed in the patients included in the study. According to one of the most extensive series published in the literature, iron carboxymaltose is an efficient and safe alternative for cancer patients with iron-deficiency anemia.

Topics: Adult; Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Hemoglobins; Humans; Iron; Neoplasms; Quality of Life; Retrospective Studies

Heavy menstrual bleeding (HMB) is the most common cause of iron deficiency anemia (IDA) in premenopausal women. Clinical studies have shown that iron carboxymaltose (ICM) is an appropriate, effective, and well-tolerated treatment option for clinical situations associated with iron deficiency (ID).. This study took 78 out of 400 consecutive patients diagnosed with IDA due to HMB and intolerant or insufficient response of oral iron. All patients were administered the total calculated dose of ICM separately, based on the body weight and current hemoglobin (Hb) level. All the anemia parameters of the patients were compared before and after treatment.. All anemia parameters, including median Hb, ferritin, and transferrin saturation, significantly increased four weeks after treatment. Pre- and post-treatment mean Hb levels were 8.9 (± 1.7) g/dL and 12.3 (± 1.2) g/dL, respectively. The mean ferritin level of the patients before treatment was 3.93 (± 2.7) ng/mL. After treatment, the mean ferritin level was 244 (± 185) ng/mL. The mean transferrin saturation levels before and after treatment were 5.7% (± 5.0) and 43.1% (± 20.9), respectively. Although no serious side effects were observed in all patients, headache was detected in 2 patients (2.6%), urticaria in 3 patients (3.8%), and flushing in 2 patients (2.6%).. ICM is an effective and safe treatment option for patients with IDA due to HMB, in which oral iron therapy is insufficient or intolerant. In fact, without waiting for the failure or intolerance of oral iron therapy, moving ICM to the frontline could be cost-effective and more convenient to patients with HMB and health care providers.

Topics: Anemia; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Hemoglobins; Humans; Iron; Maltose; Menorrhagia; Transferrins

Chronic non-specific multiple ulcers of the small intestine is a disease condition postulated in Japan. It is an uncommon gastrointestinal disease that causes chronic anemia and hypoalbuminemia by causing numerous ulcers without any histopathologically identifiable features. In recent years, it has been revealed that the mutations of SLCO2A1, which codes the prostaglandin transporter protein, are the cause of this disease;it is called the new name "chronic enteropathy associated with SLCO2A1 gene." The ileum, except the terminal ileum, is the most common place making it difficult to identify major lesions. Other than conservative treatments, such as nutrition therapy and iron supplements, no effective treatment has been identified so far. We present a case of chronic non-specific multiple ulcers of the small intestine diagnosed by capsule endoscopy and effectively treated by ferric carboxymaltose. A 48-year-old female had chronic iron deficiency anemia since around the age of 15. Because of severe anemia, the patient had upper and lower endoscopy at the age of 47 to find the source of the bleeding, but it was not detected. Except for the terminal ileum, the capsule endoscopy revealed ring-like ulcers, tape-like ulcers, and oblique ulcer scars in the ileum. Genetic analysis showed a homozygous mutation in intron 7, c.940+1G>A, indicating a definitive diagnosis of non-specific multiple ulcers of the small intestine. Anemia and anemia-related symptoms such as general malaise persisted despite continuous oral administration of iron drugs. Three intravenous injections of ferric carboxymaltose increased hemoglobin and enhanced the symptoms.

Topics: Anemia; Anemia, Iron-Deficiency; Capsule Endoscopy; Female; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Iron; Maltose; Middle Aged; Organic Anion Transporters; Ulcer

Ferric carboxymaltose (FCM) can be used in Patient Blood Management (PBM) to promote the optimization of preoperative haemoglobin (Hb), which aims to minimise the use of allogeneic blood components and improve clinical outcomes, with better cost-effectiveness. This was an observational study conducted in a retrospective and multicentre cohort with adults from elective orthopaedic, cardiac and colorectal surgeries, treated according to local standards of PBM with allogeneic blood product transfusions (ABTs) on demand and with FCM to correct iron deficiency with or without anaemia. In this work, only the first pillar of the PBM model issue by Directorate-General for Health (DGS) was evaluated, which involves optimising Hb in the preoperative period with iron treatment if it's necessary/indicated. Before the implementation of PBM in Portugal, most patients did not undergo preoperative laboratory evaluation with blood count and iron kinetics. Therefore, the existence of Iron Deficiency Anaemia (IDA) or Iron Deficiency (ID) without anaemia was not early detected, and there was no possibility of treating these patients with iron in order to optimise their Hb and/or iron stores. Those patients ended up being treated with ABTs on demand. A total of 405 patients from seven hospitals were included; 108 (26.7%) underwent FCM preoperatively and 197 (48.6%) were transfused with ABTs on demand. In the FCM preoperative cohort, there was an increase in patients with normal preoperative Hb, from 14.4 to 45.7%, before and after FCM, respectively, a decrease from 31.7 to 9.6% in moderate anaemia and no cases of severe anaemia after FCM administration, while 7.7% of patients were severely anaemic before FCM treatment. There were significant differences (p < 0.001) before and after correction of preoperative anaemia and/or iron deficiency with FCM in Hb, serum ferritin and transferrin saturation rate (TS). In the ABT group, there were significant differences between pre- and postoperative Hb levels (p < 0.001). Hb values tended to decrease, with 44.1% of patients moving from mild anaemia before transfusion to moderate anaemia in the postoperative period. Concerning the length of hospital stay, the group administered with ABTs had a longer hospital stay (p < 0.001). Regarding the clinical outcomes of nosocomial infection and mortality, there was no evidence that the rate of infection or mortality differed in each group (p = 0.075 and p = 0.243, respectively). However, there we

Topics: Adult; Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Hemoglobins; Hospitals; Humans; Iron; Maltose; Portugal; Retrospective Studies; State Medicine

Topics: Administration, Intravenous; Adolescent; Anemia; Anemia, Iron-Deficiency; Child; Ferric Compounds; Humans; Iron; Maltose; Risk Assessment

Anemia is one of the most common problems of pregnancy. In this study, we aimed to compare the maternal and fetal outcomes in labor and delivery in women whose anemia was treated with intravenous iron and women who delivered with uncorrected anemia.. METHODS: This retrospective case-control study was carried out in a tertiary obstetric care center. Term (> 37 weeks), singleton, low-risk pregnant women who were admitted for delivery were evaluated. Seventy-two pregnant women who had intravenous ferric carboxymaltose treatment in the third trimester were compared with 72 women who were anemic (Hb < 10 g/dL) at the time Queryof admission for delivery.. The groups were similar in terms of age, parity, and gestational age. The mean gestational age of the study group was 38.6 weeks. Their mean Hb of 8.2 ± 0.8 g/dL improved to 11.1 ± 1.3 g/dL prior birth. The mean Hb of the anemic group was 9.1 ± 0.5 g/dL upon admission for birth. The mean APGAR scores, admission to neonatal intensive care unit, and the rates of preterm delivery, small for gestational age, and low-birth weight infant were similar between groups. The primary cesarean section rate was significantly higher in anemic women (4.2% vs. 19.4%; p < 0.001) and the need for postpartum blood transfusion also decreased with iv iron treatment (8.3% vs. 29.2%; p = 0.02).. Correction of anemia with intravenous ferric carboxymaltose in the third trimester does not significantly change neonatal outcomes but it is effective in reducing maternal morbidity.

Topics: Adult; Anemia; Case-Control Studies; Cesarean Section; Female; Ferric Compounds; Gestational Age; Humans; Infant; Infant, Newborn; Infant, Small for Gestational Age; Injections, Intravenous; Iron; Maltose; Pregnancy; Pregnancy Complications, Hematologic; Pregnancy Outcome; Pregnancy Trimester, Third; Pregnant Women; Retrospective Studies; Turkey

Topics: Aged; Anemia; Erythrocyte Volume; Erythrocytes, Abnormal; Female; Ferric Compounds; Gastrointestinal Hemorrhage; Hemoglobins; Hemorrhoids; Humans; Infusions, Intravenous; Leucovorin; Maltose; Rectum; Reticulocyte Count; Vitamin B 12

Topics: Abdomen; Administration, Intravenous; Anemia; Biomarkers; Blood Loss, Surgical; Blood Transfusion; Drug Administration Schedule; Ferric Compounds; Hematinics; Hemoglobins; Humans; Maltose; Randomized Controlled Trials as Topic; Risk Factors; Treatment Outcome

In non-dialysis-dependent chronic kidney disease (NDD-CKD), erythropoiesis-stimulating agents (ESAs) and iron supplementation are essential for anemia management. Ferric carboxymaltose (FCM) is a relatively novel intravenous iron formulation used in different clinical settings, although scarce data exist in NDD-CKD patients. Primary objective of this study was to retrospectively evaluate the efficacy of FCM compared with oral ferrous sulfate for the treatment of iron-deficiency anemia in a cohort of NDD-CKD patients, considering also the treatment costs. This was a monocentric, retrospective observational study reviewing 349 NDD-CKD patients attending an outpatient clinic between June 2013 and December 2016. Patients were treated by either FCM intravenous infusion or oral ferrous sulfate. We collected serum values of hemoglobin, ferritin and transferrin saturation (TSAT) and ESAs doses at 12 and 18 months. The costs related to both treatments were also analysed. 239 patients were treated with FCM intravenous infusion and 110 patients with oral ferrous sulfate. The two groups were not statistically different for age, BMI and eGFR values. At 18 months, hemoglobin, serum ferritin and TSAT values increased significantly from baseline in the FCM group, compared with the ferrous sulfate group. ESAs dose and rate of infusion decreased only in the FCM group. At 18 months, the treatment costs, analysed per week, was higher in the ferrous sulfate group, compared with the FCM group, and this was mostly due to a reduction in ESAs prescription in the FCM group. Routine intravenous FCM treatment in an outpatient clinic of NDD-CKD patients results in better correction of iron-deficiency anemia when compared to ferrous sulfate. In addition to this, treating NDD-CKD patients with FCM leads to a significant reduction of the treatment costs by reducing ESAs use.

Topics: Aged; Anemia; Costs and Cost Analysis; Darbepoetin alfa; Ferric Compounds; Ferrous Compounds; Hematologic Tests; Hemoglobins; Humans; Iron; Maltose; Renal Insufficiency, Chronic; Retrospective Studies; Time Factors; Treatment Outcome

Preoperative treatment of anemia with intravenous iron is inconsistent despite known risks of anemia and allogeneic blood transfusions. Limited research exists on the effectiveness of preoperative intravenous iron for chronic kidney disease (CKD) patients. We discuss a patient with severe anemia from advanced CKD, endometrial cancer, and menometrorrhagia. Her hemoglobin increased more than 2 g/dL after erythropoietin and two 750-mg ferric carboxymaltose infusions 5 weeks before a total abdominal hysterectomy and avoided blood transfusions perioperatively. By raising hemoglobin, preoperative intravenous iron and erythropoietin reduce blood transfusions and consequent risk of future allograft rejection and alloimmunization in potential transplant recipients.

Topics: Administration, Intravenous; Anemia; Endometrial Neoplasms; Erythropoietin; Female; Ferric Compounds; Hemoglobins; Humans; Hysterectomy; Infusions, Intravenous; Iron; Kidney Diseases; Maltose; Middle Aged; Preoperative Care; Severity of Illness Index; Trace Elements; Treatment Outcome

Anaemia is highly prevalent in cancer patients, adversely affects quality of life and impacts survival. The pathogenesis is multifactorial, with iron deficiency being a major and potentially treatable contributor. This study aimed to assess the effectiveness and economic impact of ferric carboxymaltose in chemotherapy-induced anaemia. This prospective cohort study between 2015-2016 of chemotherapy-treated patients for solid tumours, grade ≥2 anaemia and iron deficiency evaluated hematopoietic response four weeks after ferric carboxymaltose treatment. Transfusion rate of all cancer patients treated at our ambulatory unit during the two-year study period (2015-2016) was compared to a retrospective cohort (2013-2014) who received blood transfusion only. Between 2015-2016, 99 patients were included and treated with ferric carboxymaltose, the majority of whom (n = 81) had relative iron deficiency. Mean haemoglobin concentrations improved from 9.2 [6.7-10.8] g/dL to 10.6 [7.8-14.2] g/dL four weeks after treatment. A 26% reduction in the transfusion rate was observed from control retrospective to the prospective study group including ferric carboxymaltose treated patients [relative risk 0.74 (95% CI:0.66-0.83)]. The cost analysis showed a benefit for the use of ferric carboxymaltose in chemotherapy-induced anaemia. This study shows that ferric carboxymaltose is an effective, cost-saving support treatment, reducing the need for allogeneic transfusions saving blood units which are a limited resource.

Topics: Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Female; Ferric Compounds; Humans; Male; Maltose; Middle Aged; Neoplasms; Quality of Life; Retrospective Studies; Treatment Outcome

The aim of this study was to assess the efficacy and safety of intravenous ferric carboxymaltose (FCM) following hospitalization for acute gastrointestinal bleeding (AGIB) in the context of a restrictive transfusion strategy.. A retrospective single-center study analyzed patients with AGIB (excluding AGIB secondary to portal hypertension) administered a single FCM dose with or without blood transfusion.. Eighty-six episodes in 84 patients were analyzed. Seventy-nine patients had upper AGIB. Nineteen episodes were associated with hemodynamic instability. FCM was administered during hospitalization as a single dose of 1000 mg iron in 84/86 episodes and as a single dose of 500 mg iron in two episodes, with blood transfusion in 60/86 (69.8%) episodes. The mean hemoglobin (Hb) was 9.0 g/dl at admission, 7.6 g/dl at the lowest in-hospital value, 9.4 g/dl at discharge, and 12.7 g/dl at follow-up (mean: 55 days postdischarge) (P<0.001 for follow-up vs. all other timepoints). The lowest mean in-hospital Hb value was 7.2 and 8.8 g/dl, respectively, in patients with transfusion+FCM versus FCM alone; the mean Hb was 12.4 versus 13.7 g/dl at follow-up. In patients administered FCM alone, the mean Hb at follow-up in the subpopulations aged older than or equal to 75 years (n=33), Charlson comorbidity index of at least 3 (n=48), and Hb of up to 10 g/dl at admission (n=47) were 12.6, 13.1, and 13.3 g/dl, respectively. No adverse effects were detected.. Treatment with FCM for AGIB is associated with a good erythropoietic response and anemia correction after hospitalization, even in severe episodes or when transfusion is needed. FCM is safe and well tolerated, and may support a restrictive transfusion policy.

Topics: Aged; Aged, 80 and over; Anemia; Biomarkers; Blood Transfusion; Erythropoiesis; Female; Ferric Compounds; Gastrointestinal Hemorrhage; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Length of Stay; Male; Maltose; Middle Aged; Patient Admission; Retrospective Studies; Spain; Time Factors; Treatment Outcome

Erythropoietin (EPO) is proposed preoperatively to reduce blood transfusion in anemic patients (hemoglobin < 13 g/dL) scheduled for a major orthopedic surgery. New intravenous iron formulations allow infusion of higher doses, increasing EPO response. In that context, we evaluated in a before-after study (n = 62 and 65 patients for each period) a new EPO administration protocol (2 injections 4 and 3 weeks before surgery, and a third if hemoglobin <13 g/dL instead of <15 g/dL 2 weeks before surgery). After this protocol implementation, the mean (standard deviation) number of EPO injections decreased from 2.8 (0.5) to 2.2 (0.4)/patient (P < .0001) without changing transfusion rates (3% in the 2 periods).

Topics: Aged; Aged, 80 and over; Anemia; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Biomarkers; Blood Loss, Surgical; Blood Transfusion; Drug Administration Schedule; Drug Compounding; Erythropoietin; Female; Ferric Compounds; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Injections, Subcutaneous; Male; Maltose; Middle Aged; Program Evaluation; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

Anemia represents one of the most common and often the least treated complications of inflammatory bowel disease (IBD).. Our study investigates experiences and preferences concerning anemia treatment in patients with IBD.. IBD patients previously diagnosed with anemia were invited to participate in an anonymous survey between July and September 2015, which assessed demographic and clinical data, and experiences regarding anemia treatment.. A total of 118 IBD patients were invited to participate in the study, of which 100 (85%) were included in the analysis. Seventy-five percent of patients reported a high personal burden related to intravenous therapy, while the majority of companions (76%) declared a moderate burden. The increased importance assigned to the possibility of a single session treatment was significantly associated with age (Beta=0.01; p=0.03), working status (Beta=0.02; p=0.04), anemia severity (severe vs. mild, Beta=0.42; p=0.03), and intravenous treatment (Beta=0.44; p=0.001).. Most patients reported a high personal and a moderate companions' burden. Having the possibility of effective single dose intravenous therapy was of great importance. Patients' perspective provides key information for evaluating the indirect costs of anemia treatment in IBD which, according to the health technology assessment approach, could be useful in a patient centered decision making process.

Topics: Absenteeism; Administration, Intravenous; Administration, Oral; Adult; Anemia; Caregivers; Cost of Illness; Cross-Sectional Studies; Employment; Female; Ferric Compounds; Health Care Surveys; Hemoglobins; Humans; Inflammatory Bowel Diseases; Iron; Male; Maltose; Middle Aged; Patient Preference; Severity of Illness Index

Topics: Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Humans; Maltose

Topics: Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Humans; Maltose

This report describes the results of an observational, retrospective cohort study, evaluating the use of iron sucrose (IS) and red blood cell (RBC) transfusions in patients with cancer in routine clinical practice in France. A parallel investigated cohort treated with ferric carboxymaltose (FCM) has been reported earlier.. Data of patients with a solid tumour or haematological malignancy who have received IS or an RBC transfusion during 2010 from 3 months prior (M. Both IS and RBC transfusions effectively increased Hb levels in patients with cancer. IS was safe and well tolerated in this population. Considering prior reported results with FCM, using FCM may reduce ESA dose requirements and the required number of infusions.

Topics: Adult; Aged; Anemia; Erythrocyte Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; France; Glucaric Acid; Hematologic Neoplasms; Hemoglobins; Humans; Male; Maltose; Middle Aged; Neoplasms; Retrospective Studies

The purpose of the study was to evaluate the efficacy of preoperative intravenous (IV) ferric carboxymaltose (FCM) administration vs. no-IV iron in colon cancer (CC) anemic patients undergoing elective surgery with curative intention.. This was a multicenter, observational study including two cohorts of consecutive CC anemic patients: the no-IV iron treatment group was obtained retrospectively while FCM-treated patients were recorded prospectively.. A total of 266 patients were included: 111 received FCM (median dose 1000 mg) and 155 were no-IV iron subjects. Both groups were similar in terms of demographic characteristics, tumor location, surgical approach, and intra-operative bleeding severity. The FCM group showed a significant lower need for red blood cell (RBC) transfusion during the study (9.9 vs. 38.7%; OR: 5.9, p < 0.001). In spite of lower hemoglobin levels at baseline diagnosis and lower transfusion rates in the FCM group, the proportion of responders was significantly higher with respect to the no-IV group both at hospital admission (48.1 vs. 20.0%, p < 0.0001) and at 30 days post-surgery (80.0 vs. 48.9%, p < 0.0001). The percentage of patients with normalized hemoglobin levels was also higher in the FCM group (40.0 vs. 26.7% at 30 days, p < 0.05). A lower number of reinterventions and post-surgery complications were seen in the FCM group (20.7 vs. 26.5%; p = 0.311). The FCM group presented a significant shorter hospital stay (8.4 ± 6.8 vs. 10.9 ± 12.4 days to discharge; p < 0.001).. Preoperative ferric carboxymaltose treatment in patients with CC and iron deficiency anemia significantly reduced RBC transfusion requirements and hospital length of stay, reaching higher response rates and percentages of normalized hemoglobin levels both at hospital admission and 30 days post-surgery.

Topics: Aged; Anemia; Blood Transfusion; Colonic Neoplasms; Erythrocyte Indices; Female; Ferric Compounds; Hemoglobins; Humans; Iron; Length of Stay; Male; Maltose; Postoperative Complications; Transplantation, Homologous; Treatment Outcome

Patient blood management (PBM) must be promoted in orthopedic surgery and relies on different strategies implemented during the entire perioperative period. Our aim was to assess whether the introduction of a pre-, intra-, and postoperative PBM protocol combining erythropoietin (EPO), ferric carboxymaltose (FCM), and tranexamic acid was effective in reducing perioperative transfusion and postoperative anemia.. In a two-phase prospective observational study, all patients admitted for total hip or knee arthroplasty were included the day before surgery. In Phase 1, use of EPO, iron, and tranexamic acid was left to the discretion of the anesthesiologists. In Phase 2, a protocol combining these treatments was implemented in the perioperative period. Perioperative hemoglobin levels and transfusion rates were recorded.. A total of 367 patients were included (184 and 183 in Phase 1 and 2, respectively). During Phase 2, implementing a PBM protocol allowed an increase in preoperative EPO prescription in targeted patients (i.e., with Hb < 13 g/dL; 18 [38%] vs. 34 [62%], p = 0.03) and in postoperative use of intravenous iron (12 [6%] vs. 32 [18%], p = 0.001) and tranexamic acid (157 [86%] vs. 171 [94%] patients, p = 0.02). In Phase 2, the number of patients who received transfusions (24 [13%] vs. 5 [3%], p = 0.0003) and of patients with a Hb level of less than 10 g/dL at discharge (46 [25%] vs. 26 [14%], p = 0.01) were reduced.. Introduction of a PBM protocol, using EPO, FCM, and tranexamic acid, reduces the number of perioperative transfusions and of patients with a Hb level of less than 10 g/dL at discharge.

Topics: Adult; Anemia; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Blood Transfusion; Controlled Before-After Studies; Erythropoietin; Female; Ferric Compounds; Humans; Male; Maltose; Orthopedic Procedures; Perioperative Period; Postoperative Period; Prospective Studies; Tranexamic Acid

Introduction Preoperative anaemia remains undertreated in the UK despite advice from national agencies to implement blood conservation measures. A local retrospective audit of 717 primary hip/knee replacements in 2008-2009 revealed 25% of patients were anaemic preoperatively. These patients experienced significantly increased transfusion requirements and length of stay. We report the results of a simple and pragmatic blood management protocol in a district general hospital. Methods Since 2010 patients at our institution who are found to be anaemic when listed for hip/knee replacement have been offered iron supplementation and/or erythropoietin depending on haemoglobin and ferritin levels. In this study, postoperative blood transfusions, length of stay and readmissions were assessed retrospectively for all patients undergoing elective primary hip/knee replacement in 2014 and compared with the baseline findings. Results During the 12-month study period, 406 patients were eligible for inclusion and none were excluded. Eighty-nine patients (22%) were anaemic preoperatively and sixty-five received treatment. The transfusion rate fell from the baseline levels of 23.0% and 6.7% to 4.3% and 0.5% for hip and knee replacements respectively (p<0.001). The median length of stay reduced from 6 to 3 days (p<0.001) for both hip and knee replacements. The rate for readmissions within 90 days fell from 13.5% to 8.9% (p<0.05). Conclusions Preoperative anaemia is common in patients listed for hip/knee replacement and it is associated strongly with increased blood transfusion. The introduction of a blood management protocol has led to significant reductions in transfusion and length of stay, sustained over a four-year period. This suggests that improved patient outcomes, conservation of blood stocks and cost savings can be achieved.

Topics: Anemia; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Blood Transfusion; Clinical Protocols; Epoetin Alfa; Ferric Compounds; Ferritins; Hematinics; Hemoglobins; Hospitals, General; Humans; Length of Stay; Maltose; Patient Readmission; Postoperative Complications; Preoperative Care; Retrospective Studies; United Kingdom

Intravenous iron supplementation is an effective therapy in iron deficiency anemia (IDA), but controversial in anemia of inflammation (AI). Unbound iron can be used by bacteria and viruses for their replication and enhance the inflammatory response. Nowadays available high molecular weight iron complexes for intravenous iron substitution, such as ferric carboxymaltose, might be useful in AI, as these pharmaceuticals deliver low doses of free iron over a prolonged period of time. We tested the effects of intravenous iron carboxymaltose in murine AI: Wild-type mice were exposed to the heat-killed Brucella abortus (BA) model and treated with or without high molecular weight intravenous iron. 4h after BA injection followed by 2h after intravenous iron treatment, inflammatory cytokines were upregulated by BA, but not enhanced by iron treatment. In long term experiments, mice were fed a regular or an iron deficient diet and then treated with intravenous iron or saline 14 days after BA injection. Iron treatment in mice with BA-induced AI was effective 24h after iron administration. In contrast, mice with IDA (on iron deficiency diet) prior to BA-IA required 7d to recover from AI. In these experiments, inflammatory markers were not further induced in iron-treated compared to vehicle-treated BA-injected mice. These results demonstrate that intravenous iron supplementation effectively treated the murine BA-induced AI without further enhancement of the inflammatory response. Studies in humans have to reveal treatment options for AI in patients.

Topics: Administration, Intravenous; Anemia; Animals; Biomarkers; Brucella abortus; Cytokines; Diet; Ferric Compounds; Hepcidins; Inflammation; Iron; Maltose; Mice; Reticulocytes; RNA, Messenger

Topics: Anemia; Ferric Compounds; Humans; Iron; Maltose; Prospective Studies

Topics: Anemia; Anemia, Iron-Deficiency; Dietary Supplements; Ferric Compounds; Humans; Iron; Maltose; Prospective Studies

There is no standard treatment for patients with severe anemia who refuse blood transfusion or cannot receive red blood cells.. After an orthotopic liver transplantation, an elderly Jehovah's Witness who refused blood transfusion presented with severe acute anemia with hemorrhagic shock. The calculated red blood cell loss was near 70%. Associated with surgical treatment and supportive measures, the patient was treated with high-dose erythropoietin and ferric carboxymaltose.. The patient presented a rapid increase in hemoglobin concentration and reticulocyte count with resolution of hemorrhagic shock after the proposed pharmacologic treatment combined with local hemostatic measures. She was transferred to a low-risk unit 4 days after transplantation and was discharged from the hospital on day 10. The hemoglobin concentration was normal 35 days after the bleeding event.. This case demonstrated that a protocol with high-dose erythropoietin and ferric carboxymaltose may be an option for patients with severe anemia who refuse blood transfusion or cannot receive red blood cells.

Topics: Anemia; Blood Transfusion; Erythropoietin; Female; Ferric Compounds; Humans; Jehovah's Witnesses; Liver Transplantation; Maltose; Middle Aged; Reticulocyte Count; Shock, Hemorrhagic; Treatment Outcome; Treatment Refusal

Iron deficiency and anemia are being increasingly recognized as a complication of inflammatory bowel disease (IBD). The aim of this study was to observe, in a non-interventional way, how Swedish gastroenterologists adhere to guidelines in IBD outpatients treated with intravenous ferric carboxymaltose (FCM), and the result of treatment.. Altogether 394 IBD patients (Crohn's disease (CD) 60%, ulcerative colitis (UC) 40%) from 14 centers were included. Group A (n = 216) was observed from November 2008 and group B (n = 178) from March 2010. Time of observation ranged from 12 to 29 months.. S-Ferritin (µmol/l) and transferrin saturation (T-Sat; %) were recorded at baseline in 62% and 50% in group A. Median values for Hb, ferritin and T-Sat at baseline were 111 g/l, 10 µmol/l and10%, respectively, and 134 g/l, 121 µmol/l and 20% after iron treatment (p < 0.001 for all three parameters). Similar results were found in group B. Approximately three-quarters of all patients had only one iron infusion during the study period. Median time to reinfusion was 6 (1-25) months. Only previously described infusion reactions occurred in 27 (7%) patients.. Adherence to European guidelines was rather poor and needs to be improved. The effect on iron parameters of intravenous FCM was significant, and resulted in a ferritin level that indicates an effect on the iron stores. The effect was mostly sustained for a year since only one-quarter of the patients were given repeated iron infusions. No unforeseen safety concerns emerged during the observation period.

Topics: Administration, Intravenous; Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Colitis, Ulcerative; Crohn Disease; Erythrocyte Indices; Female; Ferric Compounds; Ferritins; Guideline Adherence; Hematinics; Hemoglobins; Humans; Iron Deficiencies; Male; Maltose; Middle Aged; Practice Guidelines as Topic; Prospective Studies; Quality of Life; Sweden; Transferrin; Young Adult

To evaluate the economic impact of intravenous iron (in the form of intravenous iron preparation of ferric carboxymaltose) in three different clinical settings of iron deficiency anemia: chemotherapy-induced anemia in breast cancer, chemotherapy-induced anemia in digestive cancer, and perioperative anemia in knee and hip surgery.. The economic model compared the usual therapeutic strategies of anemia without intravenous iron and strategies including intravenous iron, in each of the three clinical settings selected. Costs related to anemia treatment by erythropoiesis-stimulating agents (ESA), blood transfusion, and intravenous iron were estimated and compared inside each setting. Cost savings were calculated from the French healthcare payer perspective. Data included in the economic model were obtained from scientific literature, public health agencies, and medical experts.. The most prominent annual cost savings were observed in chemotherapy-induced anemia in breast cancer (€997 and €360 per patient for metastatic and non-metastatic breast cancers, respectively; global cost saving, €33.6 million). This large impact of intravenous iron on costs was mainly explained by both a lower number of women treated and lower ESA dosing. Mean annual cost saving in digestive cancers and knee and hip surgery were estimated to €168 and €216 per patient and global cost savings of €7.5 and €12.1 million, respectively. Overall, annual cost savings in these three settings were estimated to €53 million including €39 million for ESA cost savings. Sensitivity analysis showed that strategies including intravenous iron remained cost-effective even with wide variations in the assumptions, particularly for cost savings on ESA.. Economic model based on literature data and expert opinions.. The present economic model suggests that use of intravenous iron, according to recommendations of international guidelines, is cost saving, particularly in chemotherapy-induced anemia in breast cancers.

Topics: Anemia; Blood Transfusion; Cost Savings; Costs and Cost Analysis; Dose-Response Relationship, Drug; Erythropoiesis; Female; Ferric Compounds; France; Hematinics; Humans; Maltose; Models, Economic

Topics: Accidents, Traffic; Adolescent; Anemia; Erythrocyte Count; Ferric Compounds; Hemoglobins; Hemorrhage; Humans; Male; Maltose; Wounds and Injuries

Anemia is common in critically ill patients, due to inflammation and blood loss. Anemia can be associated with iron deficiency and low serum hepcidin levels. However, iron administration in this setting remains controversial because of its potential toxicity, including oxidative stress induction and sepsis facilitation. The objective of this work was to determine the efficacy and toxicity of iron administration using a mouse model mimicking critical care anemia as well as a model of acute septicemia.. Prospective, randomized, open label controlled animal study.. University-based research laboratory.. C57BL/6 and OF1 mice.. Intraperitoneal injection of zymosan inducing generalized inflammation in C57BL/6 mice, followed in our full model by repeated phlebotomies. A dose equivalent to 15 mg/kg of ferric carboxymaltose was injected intravenously on day 5. To assess the toxicity of iron in a septicemia model, OF1 mice were simultaneously injected with iron and different Escherichia coli strains.. To investigate the effect of iron on oxidative stress, we measured reactive oxygen species production in the blood using luminol-amplified chemiluminescence and superoxide dismutase 2 messenger RNA levels in the liver. These markers of oxidative stress were increased after iron administration in control mice but not in zymosan-treated mice. Liver catalase messenger RNA levels decreased in iron-treated control mice. Iron administration was not associated with increased mortality in the septicemia model or in the generalized inflammation model. Iron increased hemoglobin levels in mice fed with a low iron diet and subjected to phlebotomies and zymosan 2 wks after treatment administration.. Adverse effects of intravenous iron supplementation by ferric carboxymaltose seem to be minimal in our animal models. Furthermore, iron appears to be effective in correcting anemia, despite inflammation. Studies of efficacy and safety of iron in critically ill patients are warranted.

Topics: Anemia; Animals; Antimicrobial Cationic Peptides; Catalase; Diet; Disease Models, Animal; Ferric Compounds; Hematinics; Hemoglobins; Hepcidins; Inflammation; Injections, Intravenous; Iron; Liver; Luminescence; Maltose; Mice; Mice, Inbred C57BL; Phlebotomy; Random Allocation; Reactive Oxygen Species; RNA, Messenger; Sepsis; Spleen; Superoxide Dismutase; Trace Elements; Zymosan

Topics: Anemia; Animals; Ferric Compounds; Hematinics; Maltose

Oral iron substitution has shown to be insufficient for treatment of severe iron deficiency anemia in pregnancy. Ferric carboxymaltose is a new intravenous (i.v.) iron formulation promising to be more effective and as safe as iron sucrose. We aimed to assess side effects and tolerance of ferric carboxymaltose compared to i.v. iron sucrose in pregnant women.. We performed a retrospective analysis of 206 pregnant women who were treated either with ferric carboxymaltose or iron sucrose for iron-deficiency anemia with intolerability to oral iron substitution, or insufficient hemoglobin increase after oral iron treatment, or need for rapid hemoglobin reconstitution. Primary endpoint was to evaluate the maternal safety and tolerability. Secondary endpoint was to assess efficacy of the treatment and exclude safety concerns for the fetus.. The incidence of drug-related adverse events was low and mostly mild in both groups. Mild adverse events occurred in 7.8% for ferric carboxymaltose and in 10.7% for iron sucrose. The mean rise of hemoglobin value was 15.4 g/L for ferric carboxymaltose and 11.7 g/L for iron sucrose.. Ferric carboxymaltose administration in pregnant women is well tolerated and is not associated with any relevant clinical safety concerns. Ferric carboxymaltose has a comparable safety profile to iron sucrose but offers the advantage of a much higher iron dosage at a time reducing the need for repeated applications and increasing patients' comfort. Ferric carboxymaltose is the drug of choice, if i.v. iron treatment becomes necessary in the second or third trimester of pregnancy.

Topics: Administration, Intravenous; Adolescent; Adult; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Maltose; Middle Aged; Pregnancy; Pregnancy Complications, Hematologic; Retrospective Studies; Young Adult

Topics: Adult; Aged; Aged, 80 and over; Anemia; Costs and Cost Analysis; Elective Surgical Procedures; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Male; Maltose; Middle Aged; Preoperative Care

Ferric carboxymaltose (FCM, Ferinject) was effective and well tolerated in the treatment of iron-deficiency anemia (IDA) in nine, Phase III, randomized, controlled, multicenter trials in a diverse range of indications, including patients with inflammatory bowel disease (IBD), post-partum anemia (PPA) or abnormal uterine bleeding (AUB), chronic heart failure (CHF), non-dialysis-dependent chronic kidney disease (CKD) and those undergoing hemodialysis (HD). In most trials, patients received either FCM doses of < or = 1000 mg, administered intravenously (i.v.) over < or = 15 min. or oral ferrous sulfate (FeSulf) 325 mg (65 mg iron), three times daily (t.i.d.), or 304 mg (100 mg iron), twice daily (b.i.d.). In one trial, patients on HD received 200 mg i.v. of either FCM or iron sucrose (ISC), two-to-three times weekly. In a pilot study in patients with CHF and CKD, patients received 200 mg of FCM by push injection compared with 200 mg of ISC slow injection. FCM was usually administered until the patient's calculated total iron replacement dose was achieved. Treatment with FCM improved indices of anemia (hemoglobin [Hb], ferritin and transferrin saturation [TSAT] values). In patients on HD with IDA secondary to CKD, FCM demonstrated comparable efficacy to ISC in achieving an increase in Hb. In patients with IBD or PPA, improvements in Hb levels were more rapid with FCM than with FeSulf. Patients with PPA receiving FCM compared with those receiving oral iron achieved an Hb rise > or = 2.0 g/dl earlier (7 days compared with 14 days; p < 0.001), were more likely to achieve an Hb rise > or = 3.0 g/dl at any time beginning at day 14 (86.3% compared with 60.4%; p < 0.001), and achieve an Hb > 12.0 g/dl at the end of the study (Day 42; 90.5% compared with 68.6%, p < 0.01). Serum ferritin increased in the i.v. FCM treatment group, but not in the oral iron group. Differences between groups were significant at each study interval. TSAT increased significantly at every interval in both groups; however, FCM-treated patients showed higher TSAT at each interval after the first week. FCM improved patient quality of life to an equivalent extent to oral FeSulf in patients with IBD or PPA, and to a greater extent than oral FeSulf in women with AUB. FCM also improved quality of life as well as functional symptoms and exercise capacity in patients with CHF. Safety data from more than 3000 patients showed that FCM was well tolerated. No safety concerns have been identified in breas

Topics: Anemia; Anemia, Iron-Deficiency; Breast Feeding; Female; Ferric Compounds; Ferritins; Heart Failure; Humans; Infant; Inflammatory Bowel Diseases; Maltose; Pilot Projects; Puerperal Disorders; Randomized Controlled Trials as Topic; Renal Insufficiency; Safety; Transferrin

Topics: Anemia; Drug Approval; Female; Ferric Compounds; Heart Diseases; Hematinics; Humans; Infusions, Intravenous; Maltose; Puerperal Disorders; Randomized Controlled Trials as Topic; United States