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
Who can join
Ages 15 and older · All sexes
Full 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.
About the study
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
What is being tested
- IV Iron (standard of care) (drug)
Sponsor: Nicoletta C Machin · Participants: 40 · Started: Aug 8, 2025
Contact the study team
- Nicoletta Machin, DO · Phone: (412) 209-7280
Official record on ClinicalTrials.gov — NCT07083583
Locations in the U.S.
| Pennsylvania | Hemophilia Center of Western Pennsylvania, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.