Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients with Lower Extremity Peripheral Artery Disease (Ironpad)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

6 Jun 2019 → ongoing

Decision date (initial)

2024-05-22

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514593-50-00

EudraCT number

2018-003714-40

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Therapy

Reduce the incidence of transfusion from randomization up to 30 days after the main surgery in patients with anemia who undergo revascularization surgery with chronic lower limb ischemia

Secondary objectives 1

1. -Changes and evolution of hemoglobin during admission; difference in hemoglobin (Hb) between inclusion, intervention and discharge. Hb 30 days after discharge -Establish the optimal preoperative moment of increased intravenous iron yield to increase Hb -Impact of anemia and its treatment on the length of hospital stay, morbidity and mortality and quality of life during admission and first 30 days postoperatively

Conditions and MedDRA coding

Anemia in patients with chronic ischemia of the lower limb ischemia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. -Patients of both sexes over 18 years of age. years of age. - Diagnosed with anemia, considered as as Hb <13.0 g/dL in men and Hb<12g/dL in women. in women. - Diagnosed with chronic ischemia of MMII ischemia (Rutherford-Baker grades 2-5, both included; Fontaine grades II-IV), who are going to undergo who are to undergo surgical revascularization (endovascular or open) and who accept the treatment. treatment. - Planned revascularization surgery in the approximate minimum period of time, > 48 hours to 3 weeks, from inclusion. - Patients diagnosed with iron deficiency iron deficiency anemia under treatment with oral iron in their usual medication and with an inadequate iron inadequate iron deposit for a surgical intervention (ferritin (ferritin <100 ng/ml) or functional ferropenia: ferritin functional: ferritin 100-500 ng/ml with IST < 20%. - Who are able and willing to give written informed written informed consent at the time of at the time of screening.

Exclusion criteria 1

1. - Patients with acute ischemia will be excluded. - Severe anemia < 8 g/dL. - Arterial hypertension not controlled with antihypertensive medication (considered with systolic pressure >180mmHg or diastolic >100mmHg ). - Acute renal failure or renal insufficiency with creatinine clearance <30mmHg. - Patient with documented intolerance or allergy to iron or its derivatives. - Unstable angina, defined as electrocardiographic changes with chest pain indicating myocardial ischemia at rest. - History of stroke in the previous 6 months. - Patients with thrombocytopenia of less than 50,000ug/dl or coagulation alterations. - Simultaneously participating in a clinical trial that conditions or modifies the registry. - Pregnancy or lactation (pregnancy tests in women of childbearing age according to standard practice). - Refusal of treatment or inclusion in the registry by the patient. - Patients refusing blood product transfusions (e.g. Jehovah's Witnesses). - Patients with SEPSIS criteria. - Patients with Ferritin <30 ng/mL who will be referred for digestive study. - Patients with active neoplasia. - Patients who are not able to give informed consent or understand the study procedure. - Probable or confirmed case with active SARS-CoV-2 infection. - Considering probable infection as: person with severe acute respiratory infection with clinical and radiological picture compatible with COVID-19 and negative PDIA results, or suspected cases with inconclusive PDIA. -Confirmed case with active SARS-CoV-2 infection: - Person meeting suspect case criteria and with positive PDIA. - Person who meets the criteria of a suspected case, with negative PDIA and positive IgM result by high-throughput serology. - Asymptomatic person with a positive PDIA with negative IgG or not performed. o Suspect case is defined as: any person with a clinical picture of acute respiratory infection of sudden onset with of sudden onset acute respiratory infection of any severity presenting with, among others, fever, cough or shortness of breath, with fever, cough or shortness of breath. - Other symptoms such as odynophagia, anosmia, ageusia, muscle pain, diarrhea, chest pain or headache, among others, may also be considered symptoms of suspected SARS-CoV-2 infection according to clinical criteria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Reduce the incidence of transfusion from randomization up to 30 days after the main surgery in patients with anemia who undergo revascularization surgery with chronic lower limb ischemia

Secondary endpoints 1

1. - Establish the optimal preoperative time of highest yield of iv iron to increase HB. - Changes and evolution of hemoglobin during admission; difference in Hb between inclusion, intervention and discharge. Hb 30 days after discharge. - Impact of anemia and its treatment on length of hospital stay, morbimortality and quality of life during admission and first 30 postoperative days

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Sponsor organisation

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Address

Cruces Plaza 12

City

Barakaldo

Postcode

48903

Country

Spain

Scientific contact point

Organisation

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Contact name

REGULATORIA

Public contact point

Organisation

Asociacion Instituto De Investigacion Sanitaria Biobizkaia

Contact name

REGULATORIA

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications