Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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 doses (2) when compared with other available injectable iron formulations (5-6) available at NYU Langone Health, and thus may be useful to reduce travel burden and expedite full iron repletion in patients with iron deficiency. Iron-deficiency anemia is common in patients after placement of a ventricular assist device (VAD) for treatment of end-stage heart disease. This is a pilot study to test the feasibility of iron repletion with ferumoxytol injection in 20 eligible subjects with laboratory evidence of iron deficiency after placement of a VAD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Treatments: Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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