Iron deficiency and anemia in patients with inherited bleeding disorders.
Heather VanderMeulen, Michelle Sholzberg
https://pubmed.ncbi.nlm.nih.gov/30470664/Actively Recruiting
Led by Nicoletta C Machin · Updated on 2025-10-03
40
Participants Needed
1
Research Sites
N/A
Total Duration
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 ngdL. 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
Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders
N
Nicoletta Machin, DO
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Nicoletta C Machin
Lead Sponsor
Health Resources and Services Administration (HRSA)
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/22738419/Nicoletta C Machin
Lead Sponsor
Health Resources and Services Administration (HRSA)
Collaborating Sponsor