Status:
UNKNOWN
Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With LEAD (IRONPAD)
Lead Sponsor:
Biocruces Bizkaia Health Research Institute
Collaborating Sponsors:
Sociedad Espanola de Angiologia y Cirugia Vascular
Conditions:
Anemia
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 r...
Detailed Description
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 perioperat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04083755
Start Date
August 15 2019
End Date
December 31 2025
Last Update
January 5 2023
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital de Galdakao-Usansolo.
Galdakao, Basque Country, Spain, 48960
2
Servicio de Angiología y Cirugía vascular del Hospital Universitario Cruces
Barakaldo, Biscay, Spain, 48903
3
Hospital de Getafe
Getafe, Madrid, Spain
4
Hospital General Universitario Gregorio Marañon
Madrid, Spain