Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15+
SponsorNicoletta C Machin
About this trial
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
Qualifiers
Males and Females > 15 years of age
Diagnosed with an Inherited Bleeding Disorder (Von Willebrand disease, platelet disorders, factor deficiencies, or bleeding disorder of unknown cause)
Evidence of Iron Deficiency (Ferritin < 50 ng/mL)
Receiving IV iron at Hemophilia Center of Western Pennsylvania
Disqualifiers
Previous thrombosis, VTE History.
Platelet count < 100,000 * 109/L
Concomitant use of antiplatelet drugs, anticoagulants, aspirin, NSAIDs.
Trial design
Treatments tested in this trial
- IV Iron (standard of care)
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Nicoletta C Machin
Lead sponsor
University of Pittsburgh
Sponsor institution
Health Resources and Services Administration (HRSA)
Collaborator
Source ClinicalTrials.gov