ferric-oxide--saccharated and Postoperative-Complications

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

To compare the efficacy of intravenous iron versus placebo to correct postoperative functional iron deficiency anemia in patients undergoing cardiac valvular surgery.. A prospective, single-blinded, randomized controlled study.. National Center for Cardiovascular Diseases and a university hospital.. The study comprised 150 patients with postoperative functional iron deficiency anemia after cardiac valvular surgery.. The patients were randomly assigned (1:1) to either the treatment (intravenous iron) group or the control (placebo) group.. The hemoglobin and ferritin concentrations and postoperative adverse events were collected and compared between the 2 groups. The hemoglobin concentration and the proportion of patients who had their anemia corrected or achieved hemoglobin increments of >20 g/L in the intravenous iron group were significantly higher than that in the placebo group at postoperative day 14 (p = 0.023, p = 0.037, and p = 0.001), whereas there was no statistical difference at postoperative day 7. The ferritin concentration was substantially higher at postoperative day 7 and postoperative day 14 in the intravenous iron group compared with the placebo group (both p < 0.001). There were no significant differences in rates of death, blood tranfusion, antibiotic upgrade, ventilator time >24 hours, postoperative hospital stay >10 days, poor wound healing, and perivalvular leakage between the 2 groups.. Intravenous iron could significantly increase the hemoglobin level in patients with postoperative functional iron deficiency anemia at postoperative day 14. However, there is no difference in blood transfusion requirements or postoperative adverse outcomes between the 2 groups.

Topics: Administration, Intravenous; Adult; Aged; Anemia, Iron-Deficiency; Biomarkers; Female; Ferric Oxide, Saccharated; Follow-Up Studies; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Single-Blind Method; Treatment Outcome; Young Adult

We conducted a randomized study analyzing the impact of darbepoetin alfa (DA) administration with or without intravenous (i.v.) iron on erythroid recovery after autologous hematopoietic cell transplantation (HCT). Patients were randomized between no DA (Arm 1), DA 300 μg every 2 weeks starting on Day 28 after HCT (Arm 2), or DA plus i.v. iron 200 mg on Days 28, 42, and 56 (Arm 3). The proportion achieving complete hemoglobin (Hb) response within 18 weeks (primary end point) was 21% in Arm 1 (n = 24), 79% in Arm 2 (n = 25), and 100% in Arm 3 (n = 23; P < 0.0001). Erythropoietic response was shown to be significantly higher in Arm 3 (n = 46) than in Arm 2 (n = 50; P = 0.008), resulting in lower DA use, reduced drug costs, and improved quality of life scores, but the effect on transfusions was not significant. In multivariate analysis, DA administration (P < 0.0001), i.v. iron administration (P = 0.0010), high baseline Hb (P < 0.0001), and low baseline creatinine (P = 0.0458) were independently associated with faster achievement of complete Hb response. In conclusion, DA is highly effective to ensure full erythroid reconstitution after autologous HCT when started on Day 28 post-transplant. I.v. iron sucrose further improves erythroid recovery.

Topics: Aged; Anemia; Blood Transfusion; Combined Modality Therapy; Darbepoetin alfa; Drug Therapy, Combination; Erythropoiesis; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematopoietic Stem Cell Transplantation; Humans; Infusions, Intravenous; Injections, Subcutaneous; Lymphoma; Male; Middle Aged; Multiple Myeloma; Postoperative Complications; Quality of Life; Transferrin; Transplantation Conditioning; Transplantation, Autologous

The main objective of this study was to determine the efficacy of intravenous (IV) iron sucrose therapy reducing transfusion requirements in elderly patients undergoing hip fracture surgery.. This study was a prospective randomized controlled trial involving 200 patients undergoing hip fracture surgery. Group A (100 patients) received standard treatment, while Group B (100 patients) received iron sucrose (600 mg IV). The primary endpoint was the number of patients that were transfused postoperatively. The secondary endpoints were the rate of red blood cell units used, hematimetric variables of blood tests, mortality, infection rates, length of hospital stay, and appearance of side effects.. Differences in the percentage of patients requiring transfusion (Group A 41.3% vs. Group B 33.3%) and in the number of concentrates transfused (0.87±1.21 for Group A vs. 0.76±1.16 for Group B) were not significant for the patient group as a whole, but were significant for patients with intracapsular fractures (45.7% required transfusion in Group A vs. 14.3% in Group B; p<0.005) and in patients with a baseline hemoglobin (Hb) level of 12 g/dL or more (35.2% required transfusions in Group A vs. 19% in Group B; p<0.05).. Transfusion requirements in patients with intracapsular fracture or baseline Hb level of 12 g/dL or more appear to be reduced by IV iron sucrose therapy, but there was no difference in morbidity, mortality, or length of hospital stay. The treatment is safe and hastens recovery from blood loss.

Topics: Aged; Aged, 80 and over; Anemia; Blood Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hip Fractures; Humans; Infusions, Intraventricular; Male; Perioperative Period; Postoperative Complications

Preoperative anaemia is a major risk factor for allogeneic blood transfusion (ABT) in patients undergoing hip fracture repair. We investigated the efficacy of preoperative recombinant human erythropoietin (rHuEPO) administration for reducing ABT requirements in a series of consecutive hip fracture patients presenting with haemoglobin (Hb) between 10 g/dl and 13 g/dl.. The blood conservation protocol consisted of the application of a restrictive transfusion trigger (Hb < 8 g/dl) and the perioperative administration of intravenous iron sucrose (3 x 200 mg/48 h) (group 1, n = 115). Additionally, some patients received preoperative rHuEPO (40 000 IU sc) on admission to the orthopaedic ward (group 2, n = 81).. Overall, 103 of 196 patients (52.5%) received at least one ABT unit (2.1 +/- 1.0 U/patient). However, there were significant differences in perioperative ABT rates between groups (60% vs. 42%, for groups 1 and 2, respectively; P = 0.013). Postoperative Hb on postoperative days 7 and 30 was higher in group 2 than in group 1. In addition, in group 2, Hb levels were higher on postoperative day 30 than on admission (12.7 +/- 1.0 g/dl vs. 11.9 +/- 0.8 g/dl, respectively; P = 0.030). Administration of rHuEPO did not increase postoperative complications or 30-day mortality rate. Only three mild intravenous iron adverse effects were witnessed.. In anaemic hip fracture patients managed with perioperative intravenous iron and restrictive transfusion protocol, preoperative administration of rHuEPO is associated with reduced ABT requirements. However, appropriate training, education and awareness are needed to avoid protocol violations and to limit further exposure to ABT and ABT-related risks.

Topics: Aged; Aged, 80 and over; Ascorbic Acid; Blood Loss, Surgical; Blood Transfusion; Epoetin Alfa; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Folic Acid; Fracture Fixation, Internal; Glucaric Acid; Guideline Adherence; Hip Fractures; Hospitals, University; Humans; Male; Postoperative Complications; Premedication; Prospective Studies; Recombinant Proteins; Retrospective Studies; Vitamin B 12

The transfusion rate following colorectal cancer resection is between 10 and 30 per cent. Receipt of allogeneic blood is not without risk or cost. A preoperative adjunct that reduced the need for transfusion would mitigate these risks. This study was designed to determine whether iron sucrose reduces the likelihood of postoperative blood transfusion in patients undergoing elective colorectal cancer resection.. In this randomized prospective blinded placebo-controlled trial of patients undergoing resectional surgery with a preoperative diagnosis of colorectal cancer, 600 mg iron sucrose or placebo was given intravenously in two divided doses, at least 24 h apart, 14 days before surgery. The primary outcome measures were serum haemoglobin concentration, recorded at recruitment, immediately before surgery and at discharge, and perioperative blood transfusions.. No difference was demonstrated between treatment groups (iron sucrose, 34 patients; placebo, 26) for any of the primary outcome measures, for either the whole study population or a subgroup of anaemic patients.. This pilot study provided no support for the use of intravenous iron sucrose as a preoperative adjunct to increase preoperative haemoglobin levels and thereby reduce the likelihood of allogeneic blood transfusion for patients undergoing resectional surgery for colorectal cancer.. 2005-003608-13UK (Medicines and Healthcare products Regulatory Agency).

Topics: Adult; Aged; Anemia, Iron-Deficiency; Blood Transfusion; Colorectal Neoplasms; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Iron; Male; Middle Aged; Pilot Projects; Postoperative Complications; Prospective Studies; Transferrin; Treatment Outcome; Young Adult

Anaemia is the main complication following haemodilution in paediatric cardiac surgery. Iron oral therapy is ineffective to improve anaemia. The aim of this study is to assess the effect of a single dose of intravenous iron saccharate Venofer.. Open, randomized.. 93 patients were randomized in two groups. The first one is the control group without iron supplementation and the second one received a 5 mg/kg injection of Venofer administered at day 1. Three biological factors were studied on day 1 and day 5 following surgery: haemoglobin, ferrritin and reticulocyte rate. Student test was used for statistical analysis of results.. Age, weight, haemoglobin, ferritine and reticulocyte on day 1 were similar in both group (no significant difference). On day 5 ferritin was higher in the treated group 215+/-87 vs 101+/-55 mug/l in the non treated group (P<0.001). Reticulocyte rate was also higher in the treated group 3.25+/-1.16 vs 2.65+/-0.97% (P<0.005) in the untreated group.. Postoperative systemic inflammation is probably the factor which impaired the effect of oral iron therapy. Parenteral iron may act by treating a functional iron deficiency and/or by increasing endogenous erythropoietin synthesis. Faster reversibility of anaemia following iron injection improves quality of the postoperative recovery.

Topics: Anemia; Cardiac Surgical Procedures; Child; Child, Preschool; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemodilution; Hemoglobins; Humans; Infant; Infusions, Intravenous; Male; Postoperative Complications; Reticulocyte Count; Sucrose

Patients undergoing pertrochanteric hip fracture (PHF) repair surgery often receive perioperative allogeneic blood transfusions (ABTs) to avoid the deleterious effects of anemia. Nevertheless, concerns about adverse effects of ABTs have prompted the review of transfusion practice and the search for a safer treatment of perioperative anemia.. The effect of preoperative 200 to 300 mg of intravenous (IV; Group 2; n = 55) iron sucrose administration on transfusion requirements and postoperative morbidity-mortality in patients with PHF has been prospectively investigated. A previous series of 102 PHF patients served as the control group (Group 1). All patients were older than 65 years and were operated on at the third day after admission to the hospital, by the same medical team and with the same implant.. Iron sucrose was well tolerated and reduced the transfusion rate in patients with admission hemoglobin levels of greater than 120 g per L (p < 0.05) who also received fewer units of red blood cells (p < 0.05). In addition, iron sucrose reduced postoperative infection rate (p < 0.05), but not 30-day mortality rate or mean length of hospital stay.. The administration of IV iron sucrose seems to reduce ABT requirements in patients with PHF and is associated to lower postoperative morbidity. The possible mechanisms involved in these effects are discussed.

Topics: Aged; Cross Infection; Erythrocyte Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hip Fractures; Humans; Infusions, Intravenous; Iron; Length of Stay; Male; Orthopedic Procedures; Pilot Projects; Postoperative Complications; Preoperative Care

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia; Blood Transfusion; Cardiac Surgical Procedures; Erythrocyte Count; Erythropoietin; Female; Ferric Oxide, Saccharated; Hemoglobins; Humans; Male; Middle Aged; Postoperative Complications; Retrospective Studies; Thoracotomy; Treatment Outcome

Anemia is common but under-diagnosed and often inadequately treated in KTX recipients. ID is the major cause of early-onset anemia. We introduced routine use of parenteral (IV) iron in patients (2-18 years) who had KTX between January 2011 and December 2015. We explored the clinical benefits of this practice by comparing the iron-treated subjects [TX] with historical controls who had KTX between 2005 and 2010. The prevalence of anemia at 6 months (early-onset) for the cohort (both the study group and controls) was 55% and for anemia at 12 months (late-onset) was 60%. Although cause-effect relationship may not be proven in a retrospective study design, there was a significant greater frequency of ID and anemia at 3 (P < .02) and 6 months (P < .04), and a reduced allograft function (eGFR < 60 mL/min/1.73 m

Topics: Adolescent; Allografts; Anemia, Iron-Deficiency; Child; Dose-Response Relationship, Drug; Female; Ferric Oxide, Saccharated; Follow-Up Studies; Hematinics; Humans; Infusions, Parenteral; Kidney Transplantation; Male; Postoperative Complications; Prevalence; Retrospective Studies; Time Factors; Transplant Recipients; United States

CASE 1: An 80-year-old man presented at our hospital with pain in both knees.He had received continuous intravenous administration of saccharated ferric oxide (SFO) over a period of five years following a diagnosis of iron-deficiency anemia.Blood tests revealed hypophosphatemia (1.4 mg/dl) and high circulating levels of fibroblast growth factor 23 (FGF23) at 248.8 mg/dl.These findings led to the diagnosis of FGF23-related osteomalacia due to SFO administration.Accordingly, the treatment plan was first to discontinue SFO, which led to a decrease in pain and normalization of phosphorus and FGF23 after 1 month.CASE 2: A 63-year-old woman presented at our hospital with leg pain.She had undergone total gastrectomy for gastric cancer at 36 years of age.Blood tests revealed hypocalcemia (8.3 mg/dl) and hypophosphatemia (2.2 mg/dl), and 25(OH)D at no more than 5 pg/ml.Bone X-rays showed significantly diminished bone shadowing.These findings led to a diagnosis of vitamin D-deficient osteomalacia due to impaired absorption following total gastrectomy.For therapy, she was treated with 1 μg/day oral alfacalcidol.Two months after initiating treatment, the pain improved.. When a patient is diagnosed with unexplained pain, it is important to pay attention to the possibility of an iatrogenic etiology.

Topics: Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Gastrectomy; Glucaric Acid; Humans; Hypophosphatasia; Iatrogenic Disease; Male; Middle Aged; Osteomalacia; Postoperative Complications; Vitamin D Deficiency

To determine whether administration of intravenous iron in a patient diagnosed with hip fracture reduces the need for blood transfusion.. A retrospective observational case-control study was performed comparing a control group of 63 patients diagnosed with hip fracture with another group of 57 patients treated with parenteral iron. Demographic, clinical condition/clinical record and hematometric differences of the case-control patients were described. We analyzed the morbidity (post-surgical infection) and mortality rate. SPSS(®) was used for statistical studies.. Being statistically significant, after the administration of intravenous iron sucrose, the need of blood transfusion was reduced in the case group, as well as the quantity of concentrates required (1.37 vs 0.6). In the case group, there was a statistically significant decreasing trend in hospital mortality rate (case group: 0.8%/control group: 8.3%). It was not been proven the relation between the decrease in nosocomial infection and the administration of intravenous iron. The administration of intravenous iron sucrose in patients diagnosed with hip fracture before surgery could be effective blood saving measure in this type of trauma surgery. Furthermore, its use has been reliable without causing any side effects.

Topics: Aged; Aged, 80 and over; Blood Loss, Surgical; Blood Transfusion; Case-Control Studies; Cross Infection; Drug Evaluation; Erythrocyte Transfusion; Erythropoiesis; Female; Femoral Neck Fractures; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hip Fractures; Humans; Infusions, Intravenous; Male; Postoperative Complications; Premedication; Preoperative Care; Retrospective Studies; Surgical Wound Infection

Topics: Anemia, Iron-Deficiency; Blood Transfusion; Colorectal Neoplasms; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Postoperative Complications; Preoperative Care; Randomized Controlled Trials as Topic

Topics: Anemia, Iron-Deficiency; Blood Transfusion; Colorectal Neoplasms; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Postoperative Complications; Randomized Controlled Trials as Topic

An important percentage of patients affected by hip fracture require the administration of allogenic blood transfusion (ABT) to avoid the risks of perioperative acute anaemia. However, concerns about ABT risks have led to the search for alternatives, especially in elective orthopaedic surgery.. We have prospectively investigated the effect of preoperative intravenous 200-300 mg (group 2; n=20) iron sucrose on ABT requirements and postoperative morbid-mortality in patients undergoing surgery for displaced subcapital hip fracture (DSHF) repair. A previous series of 57 DSHF patients served as the control group (group 1). All patients were older than 65 years, were operated on the 3rd day after admission to the hospital, by the same medical team, and using the same implant. Age, gender, ASA classification, surgical procedure, perioperative haemoglobin, requirements for ABT, postoperative infection, length of hospital stay (LOS) and 30-day mortality rate were examined.. No adverse reactions to the iron administration were observed. The iron group had a lower transfusion rate (15% vs 36.8%), lower transfusion index (0.26 vs 0.77 units per patient), lower 30d mortality rate (0 vs 19.3%), shorter LOS (11.9 vs 14.1 days), as well as a trend to a lower postoperative infection rate (15% vs 33%).. Preoperative parenteral iron administration could be a safe and effective way to reduce the ABT requirements in DSHF patients. This reduction in the ABT requirements is accompanied by a reduction in the morbid-mortality rate and LOS. A large, randomised, controlled trial to confirm these results is warranted.

Topics: Aged; Aged, 80 and over; Anemia; Arthroplasty, Replacement, Hip; Blood Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hip Fractures; Humans; Infusions, Intravenous; Male; Postoperative Complications; Prospective Studies

Spinal fusion surgery often leeds to massive bleeding responsible for anemia in the postoperative period. The aim of this study was to compare the effect of IV iron III hydroxide sucrose complex (Venofer) versus oral iron fumarate administration in postoperative anemia. The efficacy of both treatments was evaluated by comparing hemoglobin level in the postoperative period.. Two groups of sixteen patients, scheduled for anterior and/or posterior spinal fusion, were compared. Group 1, historical, was treated by supplementation of 10 mg/kg/day oral iron fumarate. Administration was started when hemoglobin level fell below 9 g/100 ml. Group 2 was treated by intravenous iron sucrose complex using same criteria as in group 1 for starting administration. The dosage of iron was individually adapted according to a target hemoglobin level of 13 g/100 ml and to the actual lowest hemoglobin level measured. The total iron deficit was calculated with the following formula: total iron deficit (mg) = 0.24 x body weight (kg) x (target Hb-actual Hb)(g/l). The patients were supplemented by 3 mg/kg/day until the calculated iron deficit was compensated.. Both groups were identical regarding age and lowest hemoglobin level reached in the postoperative period. Hemoglobin increased by 0.25 g/day in group 1, and by 0.36 g/day in group 2. In others words, the beneficial effect of IV iron versus oral iron administration was as high as 45 per cent (p = 0.003).. Intravenous iron therapy as ferric sucrose complex is a new and more effective form of iron therapy than oral iron therapy to restore postoperative hemoglobin after spinal surgery in children.

Topics: Administration, Oral; Adolescent; Adult; Anemia; Blood Loss, Surgical; Child; Child, Preschool; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Injections, Intravenous; Iron; Postoperative Complications; Spinal Fusion; Sucrose