Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders: a Single-arm Prospective Observational Study
Nicoletta C Machin
Summary
This is a prospective, single-arm, single-center observational study evaluating the impact of intravenous (IV) iron replacement in patients with inherited bleeding disorders and iron deficiency (ferritin \<50ng/dL). Subjects will undergo baseline bleeding assessments, quality-of-life measures, and laboratory tests before receiving standard-of-care IV iron. Follow-up blood work and questionnaires will be conducted post-replacement to assess for changes
Description
Iron deficiency is one of the most prevalent nutritional deficiencies globally. In particular, patients with an inherited bleeding disorder are at increased risk of iron deficiency/ iron deficiency anemia given the propensity of this patient population to bleed. The impact of iron deficiency on hemoglobin synthesis is well established as it remains the leading cause of anemia worldwide, especially among menstruating women. Studies have shown a prevalence of iron deficiency as high as 93% in Hemophilia B Carriers , and iron deficiency anemia in 75% of females with von Willebrand Disease. Howeve…
Eligibility
- Age range
- 15+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and Females \> 15 years of age 2. Diagnosed with an Inherited Bleeding Disorder (Von Willebrand disease, platelet disorders, factor deficiencies, or bleeding disorder of unknown cause) 3. Evidence of Iron Deficiency (Ferritin \< 50 ng/mL) 4. Receiving IV iron at Hemophilia Center of Western Pennsylvania 5. Willingness to have blood drawn 6. Willing to return to clinic 3 months post infusion for final blood draw, bleeding and quality of life assessments. Exclusion Criteria: 1. Previous thrombosis, VTE History. 2. Platelet count \< 100,000 \* 109/L 3. Concomitant…
Interventions
- DrugIV Iron (standard of care)
Participants will receive IV iron therapy as part of standard management for iron deficiency
Location
- Hemophilia Center of Western PennsylvaniaPittsburgh, Pennsylvania