Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With LEAD (IRONPAD)
Status:
Unknown status
Trial end date:
2021-03-30
Target enrollment:
Participant gender:
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 230 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 seven days prior to lower
limb revascularisation surgery. The primary outcome is to reduce the incidence of transfusion
from randomisation up to 15-45 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 15-45 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.
Phase:
Phase 4
Details
Lead Sponsor:
Asociación Instituto de Investigación Sanitaria BioCruces Biocruces Bizkaia Health Research Institute