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

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2018-003714-40-ES
• Lead Sponsor: Servicio de Angiología y Cirugía Vascular del Hospital Universitario Cruces

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 230

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 this age range

Exclusion Criteria

-Patients with acute ischemia will be excluded
-Severe anemia < 8 gr/dL
-Arterial hypertension not controlled with antihypertensive medication (considered with systolic blood pressure> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified