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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Nicoletta C Machin
Study ID
NCT07083583
Status
Recruiting
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Conditions

  • Bleeding
  • Bleeding Disorders
  • Iron
  • Platelet

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IV Iron (standard of care) — DRUG
    Participants will receive IV iron therapy as part of standard management for iron deficiency

Study Details

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

Key Dates

Start date
Aug 8, 2025
Status verified
Oct 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Iron Deficient patients with underlying bleeding disorders
    Subjects ≥15 years old with a history of an inherited bleeding disorder (including von Willebrand disease, platelet disorders, factor deficiencies, or bleeding disorder of unknown cause) and ferritin \<50 ng/mL identified during routine clinic evaluation.

Primary Outcome Measure

Change in bleeding assessment (ISTH-BAT score) [ Time Frame: Baseline to 3 months post-IV iron replacement ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hemophilia Center of Western PennsylvaniaPittsburghPennsylvania15232
Deborah Vehec
[email protected]
(412) 209-7564
Anuj Kaul
[email protected]
(412) 209-7563

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By research site
Hemophilia Center of Western Pennsylvania· Pittsburgh, PA

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