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Recruiting NCT07083583

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

Trial Parameters

Condition Bleeding Disorders
Sponsor Nicoletta C Machin
Study Type OBSERVATIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 15 Years
Max Age N/A
Start Date 2025-08-08
Completion 2027-10-01
Interventions
IV Iron (standard of care)

Brief 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 Criteria

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 use of antiplatelet drugs, anticoagulants, aspirin, NSAIDs.

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