Intravenous iron for bleeding symptoms in iron-deficient people 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
This single-center study will try IV iron infusions to see if they reduce bleeding symptoms and improve quality of life for people over 15 with inherited bleeding disorders and low iron (ferritin <50 ng/mL).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07083583 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people over 15 with a diagnosed inherited bleeding disorder, ferritin under 50 ng/mL, not taking antiplatelet or anticoagulant drugs, willing to have blood drawn and to return for a 3-month follow-up after IV iron.
Not a fit: Patients with a history of thrombosis, platelet count below 100,000/μL, or those using antiplatelet or anticoagulant medications are excluded and are unlikely to gain benefit from this protocol.
Why it matters
Potential benefit: If successful, IV iron replacement could reduce bleeding symptoms and improve quality of life in iron-deficient patients with inherited bleeding disorders.
How similar studies have performed: Preclinical mouse studies and limited human data in women with iron-deficiency anemia suggest iron affects platelet function, but using IV iron to alter bleeding in inherited bleeding disorders is relatively novel and under-studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.