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

Phase 4TerminatedNCT04080908

NYU Langone Health1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes