Authorised Therapeutic use (Phase IV) Anemia in patients with chronic ischemia of the lower limb ischemia

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

EU CTIS ID: 2024-514593-50-00

What this study is testing

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

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • -Patients of both sexes over 18 years of age. years of age. - Diagnosed with anemia, considered as as Hb <13.0 g/dL in men and Hb<12g/dL in women. in women. - Diagnosed with chronic ischemia of MMII ischemia (Rutherford-Baker grades 2-5, both included; Fontaine grades II-IV), who are going to undergo who are to undergo surgical revascularization (endovascular or open) and who accept the treatment. treatment. - Planned revascularization surgery in the approximate minimum period of time, > 48 hours to 3 weeks, from inclusion. - Patients diagnosed with iron deficiency iron deficiency anemia under treatment with oral iron in their usual medication and with an inadequate iron inadequate iron deposit for a surgical intervention (ferritin (ferritin <100 ng/ml) or functional ferropenia: ferritin functional: ferritin 100-500 ng/ml with IST < 20%. - Who are able and willing to give written informed written informed consent at the time of at the time of screening.

You likely can't join if

  • - Patients with acute ischemia will be excluded. - Severe anemia < 8 g/dL. - Arterial hypertension not controlled with antihypertensive medication (considered with systolic pressure >180mmHg or diastolic >100mmHg ). - Acute renal failure or renal insufficiency with creatinine clearance <30mmHg. - Patient with documented intolerance or allergy to iron or its derivatives. - Unstable angina, defined as electrocardiographic changes with chest pain indicating myocardial ischemia at rest. - History of stroke in the previous 6 months. - Patients with thrombocytopenia of less than 50,000ug/dl or coagulation alterations. - Simultaneously participating in a clinical trial that conditions or modifies the registry. - Pregnancy or lactation (pregnancy tests in women of childbearing age according to standard practice). - Refusal of treatment or inclusion in the registry by the patient. - Patients refusing blood product transfusions (e.g. Jehovah's Witnesses). - Patients with SEPSIS criteria. - Patients with Ferritin <30 ng/mL who will be referred for digestive study. - Patients with active neoplasia. - Patients who are not able to give informed consent or understand the study procedure. - Probable or confirmed case with active SARS-CoV-2 infection. - Considering probable infection as: person with severe acute respiratory infection with clinical and radiological picture compatible with COVID-19 and negative PDIA results, or suspected cases with inconclusive PDIA. -Confirmed case with active SARS-CoV-2 infection: - Person meeting suspect case criteria and with positive PDIA. - Person who meets the criteria of a suspected case, with negative PDIA and positive IgM result by high-throughput serology. - Asymptomatic person with a positive PDIA with negative IgG or not performed. o Suspect case is defined as: any person with a clinical picture of acute respiratory infection of sudden onset with of sudden onset acute respiratory infection of any severity presenting with, among others, fever, cough or shortness of breath, with fever, cough or shortness of breath. - Other symptoms such as odynophagia, anosmia, ageusia, muscle pain, diarrhea, chest pain or headache, among others, may also be considered symptoms of suspected SARS-CoV-2 infection according to clinical criteria.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.