IMPACT OF INTRAVENOUS IRON TREATMENT OF PREOPERATIVE ANEMIA IN PATIENTS WITH LOWER EXTREMITY PERIPHERAL ARTERY DISEASE

INTERVENTION: Trade Name: Ferinject Pharmaceutical Form: Solution for infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007‐72‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.000‐ Trade Name: TARDYFERON Product Name: TARDYFERON Pharmaceutical Form: Tablet INN or Proposed INN: IRON SULFATE DIHYDRATE Current Sponsor code: IRON SULFATE DIHYDRATE Other descriptive name: IRON SULFATE DIHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ CONDITION: Anemia in patients with chronic lower limb ischemia ; MedDRA version: 20.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851 Therapeutic area: Diseases [C] ‐ Blood and lymphatic diseases [C15] PRIMARY OUTCOME: ; Secondary Objective: ‐Changes and evolution of hemoglobin during admission; difference in hemoglobin (Hb) between inclusion, intervention and discharge. Hb 30 days after discharge; ‐Establish the optimal preoperative moment of increased intravenous iron yield to increase Hb; ‐Impact of anemia and its treatment on the length of hospital stay, morbidity and mortality and quality of life during admission and first 30 days postoperatively; Main Objective: Reduce the incidence of transfusion from randomization up to 30 days after the main surgery in patients with anemia who undergo revascularization surgery with chronic lower limb ischemia Primary end point(s): Reduce the incidence of transfusion from randomization up to 30 days after the main surgery in patients with anemia who undergo revascularization surgery with chronic lower limb ischemia Timepoint(s) of evaluation of this end point: 18 months SECONDARY OUTCOME: Secondary end point(s): 18 months Timepoint(s) of evaluation of this end point: 18 months INCLUSION CRITERIA: ‐Patients of both sexes over 18 years ‐Patients diagnosed with anemia, considered as , Hb <13.0 g/dL in mens and Hb<12g/dL in women ‐Patients diagnosed with symptomatic chronic lower limb ischemia (degrees 2‐5 by Rutherford‐Baker, both included, Fontaine II‐IV), who will undergo surgical revascularization (endovascular or open) and accept treatment ‐ Revascularization surgery scheduled in the approximate minimum period of one week, (> 7 days) from the inclusion ‐They are able and willing to give written informed consent at the time of selection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 230 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for th