Study | Serrano-Trenas et al. (2011) | Mudge et al. (2012) | Bernabeu-Wittel et al. (2016) |
---|---|---|---|
Patient population | Age > 65 undergoing hip fracture surgery | Adults undergoing living-donor or deceased-donor kidney transplantation | Age > 65 requiring hip fracture surgery with Hb levels between 90 and 120 g/L |
Country | Spain | Australia | Spain |
No. of centres | 1 | 1 | 13 |
No. of patients randomised | 200 | 102 | 303 |
Intervention | 600 mg of IV iron sucrose (Venofer) in three doses of 200 mg at 48-h intervals - First dose always administered before surgery | 500 mg of IV iron polymatose on the 4th postoperative day | 3 arms • EPOFE—subcutaneous single dose of EPO 40,000 IU and 1000 mg of IV ferric carboxymaltose • FE—1000 mg of IV ferric carboxymaltose and subcutaneous placebo (saline) |
Comparator | Usual care | 210 mg of oral slow release ferrous sulfate daily until primary endpoint was reached | Subcutaneous single dose placebo and IV placebo (saline) |
Primary outcome(s) | • Number and rate of patients transfused postoperatively in each arm | • Resolution of anaemia defined as haemoglobin concentration more than or equal to 11 g/dL for both men and women | • Percentage of patients who received an RBC transfusion during hospitalisation and after 60 days from hospital discharge |
Secondary outcome(s) | • Mean number of RBCs per patient • Changes in haematinic variables (admission, 24 h and 7 days postoperatively) • Hospital length of stay • Infection • 30-day mortality • Side-effects | • Gastrointestinal symptoms • Infusion reactions • Acute rejection episodes • Infectious episodes • Blood transfusion • ESA administration | • Number of RBC transfusions per patient • Hb levels 24 and 72 h after surgery, at discharge, and after 60 days • All-cause mortality • Adverse events • HRQoL • Medical complications—acute coronary disease, stroke, heart failure, VTE, COPD exacerbation, deterioration in renal function, infection, delirium, pressure ulcers |