Actively Recruiting

Age: 15Years +
All Genders
ID07083583

Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders: a Single-arm Prospective Observational Study

Led by Nicoletta C Machin · Updated on 2025-10-03

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Nicoletta C Machin

Lead Sponsor

H

Health Resources and Services Administration (HRSA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates how intravenous (IV) iron replacement affects patients with inherited bleeding disorders who also have iron deficiency, defined by low ferritin levels below 50 ng/dL. People with bleeding disorders are more likely to experience iron deficiency and anemia, which can impact platelet production and function, potentially worsening bleeding symptoms. The study aims to better understand this relationship by evaluating bleeding severity and platelet function before and after iron treatment. Participants will receive standard-of-care IV iron therapy in this prospective, single-center observational study. Before treatment, baseline bleeding assessments, quality-of-life questionnaires, and laboratory tests will be conducted. After the IV iron replacement, participants will return for follow-up blood work and questionnaires about three months later to measure any changes. During the study, participants will complete bleeding assessment scores such as ISTH-BAT, menstrual blood loss scores, and epistaxis severity scores before and three months after treatment. Quality of life, fatigue, physical functioning, emotional well-being, and pain will also be assessed using standardized questionnaires. Blood samples will help analyze platelet function changes. This study helps clarify how iron replacement might influence bleeding symptoms and platelet activity in this patient group.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females older than 15 years of age
  • Diagnosed with an inherited bleeding disorder such as von Willebrand disease, platelet disorders, factor deficiencies, or bleeding disorder of unknown cause
  • Evidence of iron deficiency with ferritin less than 50 ng/mL
  • Receiving intravenous iron treatment at the Hemophilia Center of Western Pennsylvania
  • Willing to have blood drawn
  • Willing to return to clinic 3 months after infusion for final blood draw and assessments
Not Eligible

You will not qualify if you...

  • History of previous thrombosis or venous thromboembolism (VTE)
  • Platelet count less than 100,000 x 10^9/L
  • Current use of antiplatelet drugs, anticoagulants, aspirin, or NSAIDs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single infusion with follow-up over 3 months

Participants receive intravenous (IV) iron therapy as part of standard management for iron deficiency.

1 infusion visit and 1 follow-up visit at 3 months

Trial Site Locations

Total: 1 location

1

Hemophilia Center of Western Pennsylvania

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

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Research Team

N

Nicoletta Machin, DO

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

The relationship between iron parameters and platelet parameters in women with iron deficiency anemia and thrombocytosis.

Mi-Jung Park, Pil-Whan Park, Yiel-Hea Seo...

https://pubmed.ncbi.nlm.nih.gov/22738419

Alterations of platelet functions in children and adolescents with iron-deficiency anemia and response to therapy.

Galila M Mokhtar, Wafaa E Ibrahim, Nevine A Kassim...

https://pubmed.ncbi.nlm.nih.gov/25026531

Platelet reactivity and platelet count in women with iron deficiency treated with intravenous iron.

Benjamin K Elstrott, Hari H S Lakshmanan, Alexander R Melrose...

https://pubmed.ncbi.nlm.nih.gov/35356666

ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders.

F Rodeghiero, A Tosetto, T Abshire...

https://pubmed.ncbi.nlm.nih.gov/20626619