Observational Study of IV Iron for Bleeding Symptoms in Inherited Bleeding Disorders
This observational study is looking at how intravenous (IV) iron, given as part of your usual care, affects bleeding symptoms in people with inherited bleeding disorders and low iron levels (iron deficiency). You could join if you are over 15, have a diagnosed inherited bleeding disorder (like Von Willebrand disease or platelet disorders), and are receiving IV iron at the Hemophilia Center of Western Pennsylvania for iron deficiency (ferritin below 50 ng/mL). The study will measure changes in bleeding using scores like the ISTH-BAT, PBAC (for menstrual blood loss), and ESS (for nosebleeds) from before you start IV iron to three months after. The current status of this study is unclear.
- Study design
- This is an observational study with 40 participants, meaning researchers will observe the effects of IV iron without assigning you to a treatment group. It is a single-arm study, where all participants receive the same intervention, and is being conducted at one center.
- What's involved
- You would have blood drawn and complete questionnaires at the start of the study. You will then receive standard-of-care IV iron, with follow-up blood work and questionnaires after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your bleeding symptoms will be assessed from the start of the study until three months after you receive IV iron replacement.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders
At a glance
Conditions
NCT07083583
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Nicoletta Machin, DO · PRINCIPAL_INVESTIGATOR · University of Pittburgh
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change in bleeding assessment (ISTH-BAT score)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)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)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.