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

Launched by BIOCRUCES BIZKAIA HEALTH RESEARCH INSTITUTE · Sep 6, 2019

Keywords

ClinConnect Summary

The IRONPAD trial is studying how intravenous iron treatment can help patients with anemia who are scheduled for surgery to improve blood flow in their legs. Anemia, which is a condition where you have low levels of hemoglobin (the protein that carries oxygen in your blood), is common in these patients and can lead to longer hospital stays and complications after surgery. This study aims to see if giving a single dose of intravenous iron before surgery can reduce the need for blood transfusions and improve recovery.

To participate, you need to be at least 18 years old, diagnosed with anemia (with specific hemoglobin levels), and scheduled for a type of surgery to help with chronic leg pain caused by poor blood flow. You should not have certain medical conditions, such as severe anemia or uncontrolled high blood pressure. If you decide to join the study, you will either receive the iron treatment or oral iron supplements a few days before your surgery. The research will look at how well your hemoglobin levels improve, how long you stay in the hospital, and how your overall health and quality of life are affected after surgery.

Gender

ALL

Eligibility 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 two days, (\> 48 hours) from the inclusion, Patients diagnosed with iron deficiency anemia being treated with oral iron in their usual medication and with inadequate iron storage for surgical intervention (ferritin \<100 ng/ml) or functional iron deficiency: ferritin 100-500 ng/ml with TSI \< 20% .
• • 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
• • 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
• • Probable or confirmed case with active SARS-CoV-2 infection
• • Patients who are not able to give their informed consent or understand the study procedure