NCT07083583 Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders
| NCT ID | NCT07083583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nicoletta C Machin |
| Condition | Bleeding Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-08-08 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Nicoletta Machin, DO
PRINCIPAL INVESTIGATOR
University of Pittburgh
Frequently Asked Questions
Who can join the NCT07083583 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Bleeding Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07083583 currently recruiting?
Yes, NCT07083583 is actively recruiting participants. Contact the research team at MANCHINN@pitt.edu for enrollment information.
Where is the NCT07083583 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07083583 clinical trial?
NCT07083583 is sponsored by Nicoletta C Machin. The principal investigator is Nicoletta Machin, DO at University of Pittburgh. The trial plans to enroll 40 participants.