Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT04797832
Eligibility Criteria:
* Inclusion criteria: (All criteria need to be met)
1. Patients admitted for TAVI.
2. Hb level 8-14 mg/dl on admission.
3. No evidence of active bleeding.
4. Patient provided informed consent.
5. The patient is able to walk without support for 6 minutes.
6. LVEF \>= 45%
* Exclusion criteria:
1. Previous allergy or anaphylaxis due to IV Iron.
2. Active malignancy undergoing treatment.
3. Status post major surgery involving substantial blood loss in the past 3 months.
4. Infection indicating IV antibiotics, not including prophylaxis for TAVI.
5. History of acquired iron overload; known haemochromatosis or first relatives with hemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
6. Hemolytic anemia.
7. History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
8. Recipient of immunosuppressive therapy or renal dialysis. History of erythropoietin, IV iron therapy, and blood transfusion in previous 30 days.
9. Musculoskeletal limitation that, in the judgement of the investigator, would impair 6-minute walk.
10. Pregnant or breastfeeding.
11. Inability to comprehend study protocol.
12. Parallel participation in another clinical trial.
13. During TAVI or the day following the procedure:
I. Major complication of death. II. Cardiogenic shock or any other condition requiring IV vasopressors. III. Major bleeding according to BARC 2 criteria or above. IV. Need for more than 2 pack cells during or after the procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04797832
Study Brief:
Protocol Section:
NCT04797832