Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With LEAD (IRONPAD)

• Status: Unknown status
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

Summary

Introduction: Anaemia due to iron and vitamin deficiency among patients with critical limb ischemia is high (>50%). The prevalence of a higher rate of anaemia extends into the three months prior to revascularization surgery, it is associated with longer hospital stays and more transfusions in addition to being a factor in poor prognoses. Study and treatment of anaemia within the perioperative period could improve the surgical outcomes, including the recovery and the quality of patients' lives. There are several types of intravenous iron preparations with different administration protocols, but there is not a consensus on the timing and type of the appropriate iron therapy. To the best of our knowledge, there is no data on the performance of intravenous iron in the management of preoperative anaemia in patients with peripheral artery disease (PAD) in vascular surgery.

Methods and analysis: The IRONPAD Study is a phase IV randomised controlled trial with two branches of treatment on the efficacy of intravenous iron therapy for the optimisation of blood use and prognosis in the perioperative period of patients with anaemia undergoing revascularisation for chronic lower limb ischemia. The study randomises 230 patients with anaemia to: treat with a single intravenous dose of ferric carboxymaltose (1000 mg) or no treatment vs oral iron supplements (if severe anaemia) a minimum of seven days prior to lower limb revascularisation surgery. The primary outcome is to reduce the incidence of transfusion from randomisation up to 15-45 days after the main surgery. The secondary outcomes will be included to establish the optimal preoperative moment of increased intravenous iron administration, to raise haemoglobin levels; to study the evolution of haemoglobin from inclusion to 15-45 days after surgery; and to determine the impact of anaemia and its treatment on the length of hospital stay, morbidity and mortality, as well as the quality of life in this period.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asociación Instituto de Investigación Sanitaria BioCruces; Biocruces Bizkaia Health Research Institute
• Treatments: Ferric Compounds; Iron

Criteria

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

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