ferric-oxide--saccharated and Hip-Fractures

to determine the safety and effect of intravenous iron sucrose on functional outcomes, delirium, nosocomial infections and transfusion requirements in older patients with hip fracture.. single-centre randomised, double-blind, placebo-controlled clinical trial.. orthogeriatric share care service at an academic tertiary care hospital. A total of 253 patients were recruited: 126 patients were assigned to intravenous iron and 127 to placebo.. on days 1, 3 and 5 after admission, the iron group received 200 mg Venofer® (iron sucrose) in 100 ml saline and the placebo group 100 ml saline. The primary outcome was absolute functional gain, considered as Barthel index (BI) at discharge minus BI on admission. Secondary outcomes included incidence of postoperative delirium according to the confusion assessment method, proportion of patients recovering prior functional status at 3 months, postoperative transfusion requirements, haemoglobin at 3 months, incidence of nosocomial infections and safety.. the median participant age was 87 (interquartile range, 82.5-91.5) years. Most patients were female (72.7%), and the median previous BI was 81(59-95). No significant effect of intravenous iron was observed for the primary outcome: the median AFG score was 17.1 points (4.8-23.3) in the intravenous iron group and 16 points (6-26) in the placebo group (P = 0.369). No significant treatment effects were observed for other functional outcomes or secondary end points.. while we found no impact of intravenous iron sucrose on functional recovery, incidence of postoperative delirium, transfusion requirements, haemoglobin at 3 months, mortality and nosocomial infections rates in older patients with hip fracture, we did find that the intervention was safe.

Topics: Administration, Intravenous; Aged; Aged, 80 and over; Delirium; Female; Ferric Oxide, Saccharated; Hip Fractures; Humans; Iron; Treatment Outcome

anaemia following hip fracture is common and associated with worse outcomes. Intravenous iron is a potential non-transfusion treatment for this anaemia and has been found to reduce transfusion rates in previous observational studies. There is good evidence for its use in elective surgical populations.. to examine the impact of intravenous iron on erythropoiesis following hip fracture.. two-centre, assessor-blinded, randomised, controlled trial of patients with primary hip fracture and no contra-indications to intravenous iron.. the intervention group received three doses of 200 mg iron sucrose over 30 min (Venofer, Vifor Pharma, Bagshot Park, UK) on three separate days. Primary outcome was reticulocyte count at day 7 after randomisation. Secondary outcomes included haemoglobin concentration, complications and discharge destination. Eighty participants were randomised.. there was a statistically significantly greater absolute final reticulocyte count in the iron group (89.4 (78.9-101.3) × 109 cells l-1 (n = 39) vs. the control (72.2 (63.9-86.4)) × 109 cells l-1 (n = 41); P = 0.019; (mean (95% confidence intervals) of log-transformed data). There were no differences in final haemoglobin concentration (99.9 (95.7-104.2) vs. 102.0 (98.7-105.3) P = 0.454) or transfusion requirements in the first week (11 (28%) vs. 12 (29%); P = 0.899). Functional and safety outcomes were not different between the groups.. although intravenous iron does stimulate erythropoiesis following hip fracture in older people, the effect is too small and too late to affect transfusion rates. Trial Registry Numbers: ISRCTN:76424792; EuDRACT: 2011-003233-34.

Topics: Administration, Intravenous; Aged, 80 and over; Anemia; Dose-Response Relationship, Drug; Erythropoiesis; Female; Ferric Oxide, Saccharated; Fracture Fixation; Hematinics; Hemoglobins; Hip Fractures; Humans; Male; Single-Blind Method

Anaemia following hip fracture is common. Approximately 30 to 45% of patients have haemoglobin concentrations below population norms on admission, and around 10% are severely anaemic. Anaemia on admission, and in the postoperative period, is associated with poor outcomes with regard to mobility, postoperative mortality and readmission. There is currently no clear consensus on the optimal method of managing perioperative anaemia in this group of frail patients with frequent comorbidity. Liberal red cell transfusion in the postoperative period does not appear to improve outcome, whereas tranexamic acid appears to reduce transfusion rate at the expense of increased cardiovascular morbidity. There are encouraging results from one centre with the use of agents to stimulate red cell production, including intravenous iron and erythropoietin. UK practice differs significantly from these patients and these studies, and it is not clear whether these promising results will translate to the UK population.. This is a single-centre randomized controlled parallel group trial, in a British university hospital.Randomization is achieved using a website and computer-generated concealed tables. Participants are 80 patients 70 years or over with acute hip fracture undergoing operative repair. The intervention group receive three daily infusions of 200 mg iron sucrose, starting within 24 hours of admission. The control group receive standard hospital care at the discretion of the clinical team. Red cell transfusions for each group are given in accordance with standard clinical triggers. The primary outcome is an increase in mean reticulocyte count in the intervention group at day 7. Secondary outcome measures include haemoglobin concentrations, early and late transfusion rates, infectious and cardiovascular complications, mobility and 30-day mortality.. This is a pilot study to demonstrate haematopoietic efficacy of intravenous iron in this setting. Hence, we have chosen to measure change in reticulocyte count rather than the more clinically relevant differences in haemoglobin concentration or transfusion rate. If our results are positive, the study will provide the necessary information for development of a full-scale trial of intravenous iron.. Current Controlled Trials ISRCTN76424792; UK Medicines and Healthcare products Regulatory Authority (EuDRACT: 2011-003233-34).

Topics: Aged; Anemia; Biomarkers; Clinical Protocols; Drug Administration Schedule; England; Erythrocyte Transfusion; Ferric Compounds; Ferric Oxide, Saccharated; Fracture Fixation; Glucaric Acid; Hematinics; Hemoglobins; Hip Fractures; Hospitals, University; Humans; Infusions, Intravenous; Pilot Projects; Postoperative Hemorrhage; Research Design; Reticulocyte Count; Time Factors; Treatment Outcome

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

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

To explore the clinical efficacy of iron sucrose combined with recombinant human erythropoietin(EPO) for the treatment of anemia in elderly patients with hip fracture.. From February 2016 to April 2018, 96 elderly anemia patients who underwent hip fracture surgery were divided into three groups according to the treatment methods. All the three groups received anti-anemia treatment 3 days before operation. Among them, 32 cases in group A were treated with iron sucrose alone, 32 cases in group B were treated with recombinant human erythropoietin alone, and 32 cases in group C were treated with iron sucrose combined with recombinant human erythropoietin. The therapeutic effects of the three groups were observed and compared.. The clinical effective rate in group C was significantly higher than that in group A and B (. Compared with single drug, the combined use of sucrose and iron and recombinant human erythropoietin in the treatment of elderly hip fracture anemia has a definite effect. It can not only effectively improve the level of hemoglobin, ensure the smooth operation, but also reduce the blood transfusion rate of patients and promote their recovery after operation.

Topics: Aged; Anemia; Erythropoietin; Ferric Oxide, Saccharated; Hemoglobins; Hip Fractures; Humans; Recombinant Proteins

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

To assess the cost-effectiveness and the budget impact of a Blood Saving Program (BSP) in patients older than 65 undergoing perthrocanteric hip fracture surgery.. Two groups of patients with perthrocanteric fracture were included. Group 1: patients not receiving treatment for perisurgical anaemia or treated with oral iron; Group 2: patients included in a BSP (treatment with endovenous iron sucrose and alfa epoetin, plus restrictive transfusional criteria). Effectiveness issues were: transfusion rate and number of red blood cell units transfused, length of postoperative stay and infection rate. Treatment cost was calculated using drug and transfused red blood cell unit prizes in 2003. We calculated potential patient population according to 2003 data.. 144 patients were included, 43 of which were in the BSP. Both groups were comparable in gender, age, preoperative length of stay, ASA and haemoglobin level at admission. Patients included in the BSP were less transfused and had less infections but postoperative stay was similar in both groups. The budget impact was 239,148 euros 95% [confidence interval (CI) 202,312-311,980] at group 1 and 311,980 euros [95% CI 275,288-348,672] at the BSP group. Including the whole potential population in the BSP (during one year 400 patients) would mean a cost increase of 72,832 euros, avoiding transfusion in 92 patients, infection in 70 patients, and saving 328 red blood cell units.. The cost increase due to endovenous iron sucrose and alfa-epoetin can be considered affordable for the hospital budget. BSP provides lower transfusion and infection rates and saves red blood cell units, compared to the standard procedure. Differences in postoperative stay should be analyzed in further larger and prospective studies including more patients.

Topics: Administration, Oral; Age Factors; Aged, 80 and over; Anemia; Budgets; Confidence Intervals; Cost-Benefit Analysis; Costs and Cost Analysis; Data Interpretation, Statistical; Epoetin Alfa; Erythrocyte Transfusion; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hip Fractures; Humans; Iron; Length of Stay; Male; Recombinant Proteins

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

An important percentage of patients with hip fracture need allogeneic transfusion to resolve their perioperative anemia. Our goal was to determine the safety profile and usefulness of parenteral iron in order to avoid allogeneic transfusions in trochanteric hip fracture (THF).. A pseudo-experimental study was performed comparing a historic THF group (n = 104) with another group (n = 23) treated with parenteral iron (Venofer) (doses of 100 mg). Patients who had primary blood diseases or were receiving anticoagulation therapy were excluded. Age, gender, elapsed time, type of THF (international AO classification), surgical procedure, transfusion procedure and quantity, hemoglobin and hematocrit at days 0 and +2 (if a surgical procedure was not performed) and postoperatively were examined. We also analyzed the morbidity (post-surgical infection) and hospital stay and mortality rate at the first month.. We have not observed any adverse reactions upon iron administration. The iron group was transfused less times (39.1% vs. 56.7%) and had lower morbidity (infection) (20.3% vs. 35.4%) (p = 0.04), lower mortality (13% vs. 16.3%), less blood consumption (0.87 vs. 1.31 units) and less stay (13.7 vs. 14.3 days).. Parenteral administration of iron could be a safe and effective way to avoid or reduce allogeneic blood transfusions in THF patients. The reduction in the transfusional rate in the iron treated group is also accompanied by a reduction in the morbidity, infection rate, mortality rate and hospital stay.

Topics: Aged; Aged, 80 and over; Anemia; Blood Loss, Surgical; Blood Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hip Fractures; Humans; Infusions, Intravenous; Iron; Male; Sucrose