Anemia in patients with chronic lower limb ischemia MedDRA version: 20.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851
Conditions
Interventions
Trade Name: Ferinject
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concen
Sponsors
Servicio de Angiología y Cirugía Vascular del Hospital Universitario Cruces
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients of both sexes over 18 years -Patients diagnosed with anemia, considered as , Hb 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 this age range
Exclusion criteria
Exclusion criteria: -Patients with acute ischemia will be excluded -Severe anemia 180mmHg or diastolic> 100mmHg) - Acute renal failure or renal failure with creatinine clearance <30mmHg -Patient with documented intolerance or allergy to iron or its derivatives -Unstable angina, defined as electrocardiographic changes with chest pain that indicate resting myocardial ischemia -History of stroke in the previous 6 months -Patients with thrombocytopenia less than 50,000ug/dl or alterations in coagulation -That you are simultaneously participating in a clinical trial that conditions or modifies the registry -Patients already diagnosed with iron-deficiency anemia in oral iron treatment in their usual medication -Pregnancy or lactation (pregnancy tests in women of childbearing age according to usual practice) -Rejection of treatment or inclusion in the registry by the patient -Patients who refuse to receive transfusions of blood products (for example, Jehovah's Witnesses) -Patients with criteria of SEPSIS -Patients with Ferritin <30 ng/ml that will be directed for digestive study -Patients with active neoplasia -Patients who are not able to give their informed consent or understand the study procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; 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 ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 18 months;Timepoint(s) of evaluation of this end point: 18 months | — |
Countries
Spain
Contacts
Public ContactServicio Vascular
Servicio de Angiología y Cirugía Vascular del Hospital Universitario Cruces
Outcome results
None listed