Recruiting

IV Iron Replacement

Sponsor:

Nicoletta C Machin

Code:

NCT07083583

Conditions

Bleeding Disorders

Iron

Platelet

Bleeding

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

IV Iron (standard of care)

Study Details

Brief summary:

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

Conditions

Bleeding Disorders

Iron

Platelet

Bleeding

Study ID

NCT07083583

Start date

Aug 8, 2025

Status verified date

Oct, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and Females > 15 years of age
2. Diagnosed with an Inherited Bleeding Disorder (Von Willebrand disease, platelet disorders, factor deficiencies, or bleeding disorder of unknown cause)
3. Evidence of Iron Deficiency (Ferritin < 50 ng/mL)
4. Receiving IV iron at Hemophilia Center of Western Pennsylvania
5. Willingness to have blood drawn
6. Willing to return to clinic 3 months post infusion for final blood draw, bleeding and quality of life assessments.

Exclusion Criteria:

1. Previous thrombosis, VTE History.
2. Platelet count < 100,000 \* 109/L
3. Concomitant use of antiplatelet drugs, anticoagulants, aspirin, NSAIDs.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Iron Deficient patients with underlying bleeding disorders

Subjects ≥15 years old with a history of an inherited bleeding disorder (including von Willebrand disease, platelet disorders, factor deficiencies, or bleeding disorder of unknown cause) and ferritin <50 ng/mL identified during routine clinic evaluation.

Interventions

IV Iron (standard of care)

Participants will receive IV iron therapy as part of standard management for iron deficiency

Primary outcome measure

  • Change in bleeding assessment (ISTH-BAT score) [ Time Frame: Baseline to 3 months post-IV iron replacement ]
  • Change in Menstrual Blood Loss (PBAC Score) [ Time Frame: Baseline to 3 months post-IV iron replacement ]
  • Change in Epistaxis Severity Score (ESS) [ Time Frame: Baseline to 3 months post-IV iron replacement ]

Central Contacts and Locations

Central contacts

Nicoletta Machin, DO

(412) 209-7280MANCHINN@pitt.edu

Locations

Hemophilia Center of Western Pennsylvania

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Deborah Vehec

(412) 209-7564dvehec@vitalant.org

Anuj Kaul

(412) 209-7563akaul@vitalant.org

More Information

Sponsor

Nicoletta C Machin

Last update posted

Oct 3, 2025

Last verified

Oct, 2025

Keywords

  • Iron deficiency
  • bleeding disorder
  • platelet function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nicoletta C Machin on 2025-10-03.