RecruitingNCT07083583

Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders

Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders: a Single-arm Prospective Observational Study


Sponsor

Nicoletta C Machin

Enrollment

40 participants

Start Date

Aug 8, 2025

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 15 Years

Inclusion Criteria6

  • Males and Females > 15 years of age
  • Diagnosed with an Inherited Bleeding Disorder (Von Willebrand disease, platelet disorders, factor deficiencies, or bleeding disorder of unknown cause)
  • Evidence of Iron Deficiency (Ferritin < 50 ng/mL)
  • Receiving IV iron at Hemophilia Center of Western Pennsylvania
  • Willingness to have blood drawn
  • Willing to return to clinic 3 months post infusion for final blood draw, bleeding and quality of life assessments.

Exclusion Criteria3

  • Previous thrombosis, VTE History.
  • Platelet count < 100,000 * 109/L
  • Concomitant use of antiplatelet drugs, anticoagulants, aspirin, NSAIDs.

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Interventions

DRUGIV Iron (standard of care)

Participants will receive IV iron therapy as part of standard management for iron deficiency


Locations(1)

Hemophilia Center of Western Pennsylvania

Pittsburgh, Pennsylvania, United States

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NCT07083583


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