NCT07083583 · Nicoletta C Machin
Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders
(IRON-BD)
What this study is about
This is a forward-looking, single-treatment group$1, single-center observational study evaluating the impact of given through a vein (IV) (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.
View original scientific description
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.
Interventions
DRUG
IV Iron (standard of care)
Participants will receive IV iron therapy as part of standard management for iron deficiency
Primary outcome measures
Change in bleeding assessment (ISTH-BAT score)
Time frame: Baseline to 3 months post-IV iron replacement
Change in bleeding severity 3 months after IV iron replacement, assessed using the ISTH-BAT (International Society on Thrombosis and Haemostasis Bleeding Assessment Tool). ISTH-BAT: Score range 0-56; higher scores indicate greater bleeding severity. Safety Issue: No
Change in Menstrual Blood Loss (PBAC Score)
Time frame: Baseline to 3 months post-IV iron replacement
Change in menstrual bleeding 3 months after IV iron replacement, measured using the Pictorial Blood Loss Assessment Chart (PBAC). Assessed only in menstruating female participants. PBAC: Score \<100 indicates normal menstrual blood loss; scores \>100 suggest heavy menstrual bleeding.
Change in Epistaxis Severity Score (ESS)
Time frame: Baseline to 3 months post-IV iron replacement
Change in epistaxis severity from baseline to 3 months post-IV iron replacement, measured using the Epistaxis Severity Score (ESS), a validated clinical tool for quantifying frequency, duration, and impact of nosebleeds. Score Range: 0 to 10 Scoring Interpretation: Higher scores indicate more severe or frequent nosebleeds. A reduction in score reflects clinical improvement.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Willingness to have blood drawn
- Willing to return to clinic 3 months post infusion for final blood draw, bleeding and quality of life assessments.
Exclusion criteria
- Previous thrombosis, VTE History.
- Platelet count \< 100,000 \
- Concomitant use of antiplatelet drugs, anticoagulants, aspirin, NSAIDs.
Where
- Pittsburgh, Pennsylvania
Collaborators
Health Resources and Services Administration (HRSA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 3, 2025 · Source of record for eligibility and locations