Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With LEAD (IRONPAD)

NCT04083755 | Unknown Phase 4 DMC

• 1 other identifier: 2018-003714-40
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Anemia; Peripheral Arterial Occlusive Disease

Keywords

anemia; iron; surgery; PAD

Outcome Measures

Primary Outcomes (1)

• To reduce the incidence of transfusion (receiving any volume of 1 unit or more than 1 unit of packed red cells) from randomisation up to 30 days (with +/- 15-day window) after the main surgery

  Number of red blood cell units of or any other blood component transfused during the surgical procedure and from the postoperative period until discharge. If surgery does not finally take place, data from the 30 days after inclusion will be registered for analysis with intention to treat.

  From inclusion date to 30 days (with +7 window) after the main surgery

Secondary Outcomes (6)

• Changes and evolution of hemoglobin during admission; difference in hemoglobin (Hb) between inclusion, intervention and discharge.

  From inclusion date to 30 days (with +7day window) after surgical procedure

• Establish the optimal preoperative moment of increased intravenous iron yield to increase Hb

  From inclusion date to 30 days (with +7 window) after the main surgery

• Impact of anemia and its treatment on the length of hospital stay

  From inclusion date to 30 days (with +7 window) after the main surgery

• Impact of anemia and its treatment on morbidity

  From inclusion date to 30 days (with +7 window) after the main surgery

• Impact of anemia and its treatment on mortality

  From inclusion date to 30 days (with +7 window) after the main surgery

Study Arms (2)

Line A

ACTIVE COMPARATOR

One dose of Ferric carboxymaltose (1000mg) intravenous. Duration of administration 15 minutes.

Drug: Ferric Carboxymaltose Injection [Injectafer]

Line B

OTHER

No treatment or treatment oral with iron supplementation if iron-deficiency anemia

Other: no treatment or oral iron supplementation

Interventions

Ferric Carboxymaltose Injection [Injectafer] DRUG

1000mg intravenous

Also known as: Ferinject

Line A

no treatment or oral iron supplementation OTHER

No treatment or treatment oral with iron supplementation if iron-deficiency anemia

Line B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• They are able and willing to give written informed consent at the time of selection

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Biobizkaia Health Research Institute: lead
• Sociedad Espanola de Angiologia y Cirugia Vascular: collaborator

Study Sites (5)

Hospital de Galdakao-Usansolo.

Galdakao, Basque Country, 48960, Spain

RECRUITING

Servicio de Angiología y Cirugía vascular del Hospital Universitario Cruces

Barakaldo, Biscay, 48903, 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

Related Publications (30)

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MeSH Terms

Conditions

Anemia; Peripheral Arterial Occlusive Disease 1

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ana Apodaka Diez, MD

  Vascular Surgeon

  PRINCIPAL INVESTIGATOR

• Jose Manuel Rodriguez Chinesta, MD

  Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Apodaka, MD

CONTACT

34946006000; ANA.APODAKADIEZ@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 10, 2019
• Study Start: August 15, 2019
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: open access to read as soon as published
• Access Criteria: open

Locations

ES (5)