Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Multicenter Double-bind Randomized Trial of Ferric Carboxymaltose With or Without Erythropoietin for the Prevention of Red-cell Transfusion in Hip Fracture Perioperative Period.
Brief Summary: In order to evaluate the efficacy of ferric carboxymaltose + erythropoietin versus ferric carboxymaltose versus placebo in reducing the percentage of patients who receive red-cell transfusion in the perioperative period of hip fracture, a multicenter, randomized, parallel groups, double-blind clinical trial in adult patients admitted for osteoporotic hip fracture is designed. Required sample size is of 87 patients per arm (87x3 = 261). Primary efficacy variable is the percentage of patients who receive red-cell transfusion during hospitalization; secondary end-points: average red-cell packs per patient,haemoglobin at 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge, hospital stay and mortality during hospital-stay and 60 days afterwards. Adverse clinical events and side effects are assessed as safety variables. In addition health related quality of life will be measured at inclusion and after 60 days. A cost-efficacy analysis (by means of incremental cost-efficacy method using as a primary endpoint each patient not requiring transfusion, and as secondary end-point every patient who survived the index admission is performed). The investigators would like to demonstrate a double benefits: optimizing precious resource such as blood products and reducing complications arising from their use.


Options:
A: Arm Label: Low transfusion trigger; Type: ACTIVE_COMPARATOR; Interventions: Biological: red blood cell transfusion | Arm Label: High transfusion trigger; Type: ACTIVE_COMPARATOR; Interventions: Biological: red blood cell transfusion | Intervention Type: BIOLOGICAL; Name: red blood cell transfusion; Assigned to Arm(s): High transfusion trigger, Low transfusion trigger
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: FE; Type: EXPERIMENTAL; Interventions: Drug: Ferric carboxymaltose | Arm Label: EPOFE; Type: EXPERIMENTAL; Interventions: Drug: Ferric carboxymaltose, Drug: Erythropoietin | Intervention Type: DRUG; Name: Ferric carboxymaltose; Assigned to Arm(s): EPOFE, FE | Intervention Type: DRUG; Name: Erythropoietin; Assigned to Arm(s): EPOFE | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Liberal Group; Type: EXPERIMENTAL; Interventions: Other: Haemoglobin 9.5 g/dL | Arm Label: Restrictive group; Type: ACTIVE_COMPARATOR; Interventions: Other: Haemoglobine 7.5g/dL | Intervention Type: OTHER; Name: Haemoglobin 9.5 g/dL; Assigned to Arm(s): Liberal Group | Intervention Type: OTHER; Name: Haemoglobine 7.5g/dL; Assigned to Arm(s): Restrictive group
D: Arm Label: Red blood cell transfusion; Type: ACTIVE_COMPARATOR; Interventions: Other: Red blood cell transfusion | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Red blood cell transfusion; Assigned to Arm(s): Red blood cell transfusion

Answer: B