Status:
UNKNOWN
IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Iron Deficiency Anemia Due to Blood Loss
Aortic Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Iron deficiency is common among patients undergoing TAVI. It is estimated at 54-79%. Previous non-randomized small trial have shown symptomatic benefit in treating iron deficiency in this group of pat...
Detailed Description
Iron deficiency (ID) among patients undergoing transcatheter aortic valve implantation (TAVI) is common (54%-79% .These patients suffer from higher mortality, unplanned readmission for worsening heart...
Eligibility Criteria
Inclusion
- Inclusion criteria: (All criteria need to be met)
- Patients admitted for TAVI.
- Hb level 8-14 mg/dl on admission.
- No evidence of active bleeding.
- Patient provided informed consent.
- The patient is able to walk without support for 6 minutes.
- LVEF \>= 45%
- Exclusion criteria:
- Previous allergy or anaphylaxis due to IV Iron.
- Active malignancy undergoing treatment.
- Status post major surgery involving substantial blood loss in the past 3 months.
- Infection indicating IV antibiotics, not including prophylaxis for TAVI.
- History of acquired iron overload; known haemochromatosis or first relatives with hemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
- Hemolytic anemia.
- 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.
- Recipient of immunosuppressive therapy or renal dialysis. History of erythropoietin, IV iron therapy, and blood transfusion in previous 30 days.
- Musculoskeletal limitation that, in the judgement of the investigator, would impair 6-minute walk.
- Pregnant or breastfeeding.
- Inability to comprehend study protocol.
- Parallel participation in another clinical trial.
- 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.
Exclusion
Key Trial Info
Start Date :
October 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04797832
Start Date
October 18 2020
End Date
October 31 2024
Last Update
October 27 2022
Active Locations (1)
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1
Rambam Medical Center
Haifa, Israel