Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With Lower Extremity Peripheral Artery Disease

Who is this study for? Patients with lower extremity peripheral artery disease
What treatments are being studied? Ferric Carboxymaltose
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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 240 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 two days prior to lower limb revascularisation surgery. The primary outcome is to reduce the incidence of transfusion from randomisation up to 30+7 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 30+7 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Servicio de Angiología y Cirugía vascular del Hospital Universitario Cruces
RECRUITING
Barakaldo
Hospital de Galdakao-Usansolo.
RECRUITING
Galdakao
Hospital de Getafe
NOT_YET_RECRUITING
Getafe
Hospital General Universitario Gregorio Marañon
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Contact Information
Primary
Ana Apodaka, MD
ANA.APODAKADIEZ@osakidetza.eus
34946006000
Time Frame
Start Date: 2019-08-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 240
Treatments
Active_comparator: Line A
One dose of Ferric carboxymaltose (1000mg) intravenous. Duration of administration 15 minutes.
Other: Line B
No treatment or treatment oral with iron supplementation if iron-deficiency anemia
Sponsors
Leads: Biocruces Bizkaia Health Research Institute
Collaborators: Sociedad Espanola de Angiologia y Cirugia Vascular

This content was sourced from clinicaltrials.gov

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