Intravenous iron treatment for anemia before surgery in patients with peripheral artery disease
Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With Lower Extremity Peripheral Artery Disease
This study is testing if giving intravenous iron to patients with anemia before surgery for leg artery problems can help them have better outcomes and fewer complications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biocruces Bizkaia Health Research Institute Government |
| Locations | 5 sites (Galdakao, Basque Country and 4 other locations) |
| Trial ID | NCT04083755 on ClinicalTrials.gov |
What this trial studies
The IRONPAD study is a phase IV randomized controlled trial that investigates the effectiveness of intravenous iron therapy in patients with anemia who are scheduled for revascularization surgery due to chronic lower limb ischemia. Patients will be randomly assigned to receive either a single dose of ferric carboxymaltose or no specific treatment. The study aims to determine if treating anemia with intravenous iron can improve surgical outcomes and reduce complications associated with anemia in this patient population. The trial will include patients with symptomatic chronic lower limb ischemia and will adhere to strict eligibility criteria to ensure accurate results.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with anemia and symptomatic chronic lower limb ischemia scheduled for elective revascularization surgery.
Not a fit: Patients with acute ischemia or severe anemia (Hb < 8 g/dL) may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve surgical outcomes and recovery for patients with anemia undergoing revascularization.
How similar studies have performed: While there is limited data on intravenous iron for preoperative anemia in peripheral artery disease, similar approaches have shown promise in other surgical contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Galdakao, Basque Country and 4 other locations
- Hospital de Galdakao-Usansolo. — Galdakao, Basque Country, Spain (Recruiting)
- Servicio de Angiología y Cirugía vascular del Hospital Universitario Cruces — Baracaldo, Biscay, Spain (Recruiting)
- Hospital de Getafe — Getafe, Madrid, Spain (Not_yet_recruiting)
- Hospital General Universitario Gregorio Marañon — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Ana Apodaka Diez, MD — Vascular Surgeon
- Study coordinator: Ana Apodaka, MD
- Email: ANA.APODAKADIEZ@osakidetza.eus
- Phone: 34946006000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.