Intravenous iron for bleeding symptoms in iron-deficient people with inherited bleeding disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, single-center observational protocol enrolling patients older than 15 with inherited bleeding disorders and ferritin <50 ng/mL who are receiving standard-of-care IV iron at the Hemophilia Center of Western Pennsylvania. Participants complete baseline bleeding assessments, platelet/hematology labs, and quality-of-life questionnaires, receive an IV iron replacement per routine care, and return about three months later for repeat bloodwork and surveys. The study tracks changes in bleeding frequency, laboratory markers including platelet function and ferritin/hemoglobin, and patient-reported outcomes. All interventions are standard clinical care and the design is intended to observe whether correcting iron deficiency correlates with changed platelet function or bleeding symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hemophilia Center of Western Pennsylvania
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Nicoletta Machin, DO — University of Pittburgh
• Study coordinator: Nicoletta Machin, DO
• Email: MANCHINN@pitt.edu
• Phone: (412) 209-7280

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.