Status:
TERMINATED
Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support
Lead Sponsor:
NYU Langone Health
Conditions:
Anemia
Eligibility:
All Genders
19-110 years
Phase:
PHASE4
Brief Summary
Ferumoxytol injection (Feraheme®) is a parenteral form of iron supplementation that is FDA-approved for treatment of iron deficiency anemia. Ferumoxytol injection achieves iron repletion in fewer dose...
Eligibility Criteria
Inclusion
- Status post placement of durable ventricular assist device with stable clinical status for \>30days
- Hemoglobin \>6 g/dL AND \<13 g/dL (men) or \<12 g/dL (women) within last 90 days
- Serum ferritin \<100 ng/mL OR Serum ferritin 100-299 ng/mL with transferrin saturation \<20% within last 90 days
- Able and willing to provide written informed consent
Exclusion
- Known hypersensitivity to Ferumoxytol injection or other intravenous iron preparation
- History of anaphylaxis
- Treatment with erythropoiesis stimulating agent or intravenous iron in last 3 months
- Renal failure on hemodialysis
- Respiratory failure on mechanical ventilation
- Disabling Stroke
- Ventricular assist device thrombosis
- Evidence of active gastrointestinal bleeding or other active blood loss
- Hospitalization \<30 days
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04080908
Start Date
January 15 2020
End Date
October 19 2021
Last Update
July 18 2023
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016