Bleeding DisordersIRON-BDNCT07083583
Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders
An observational study of Bleeding Disorders and Iron, run by Nicoletta C Machin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Bleeding Disorders, Iron, Platelet
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient in the outpatient setting with a bleeding disorder and Iron Deficiency planned for IV Iron as per Standard of care followed at the Hemophilia Center of Western Pennsylvania
Who may be able to join
- 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.
Who cannot join
- Previous thrombosis, VTE History.
- Platelet count < 100,000 * 109/L
- Concomitant use of antiplatelet drugs, anticoagulants, aspirin, NSAIDs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, 15232
Alyssa Rogalski, RN, (412) 209-7020, arogalski@vitalant.org
Dana Ivanco, (412) 209-7425, des2@pitt.edu
About this study
Official title: Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders: a Single-arm Prospective Observational Study
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
Read the detailed description
Iron deficiency is one of the most prevalent nutritional deficiencies globally. In particular, patients with an inherited bleeding disorder are at increased risk of iron deficiency/ iron deficiency anemia given the propensity of this patient population to bleed. The impact of iron deficiency on hemoglobin synthesis is well established as it remains the leading cause of anemia worldwide, especially among menstruating women. Studies have shown a prevalence of iron deficiency as high as 93% in Hemophilia B Carriers , and iron deficiency anemia in 75% of females with von Willebrand Disease. However, platelets are also affected by iron deficiency. The effect of iron deficiency, as described in the past, is primarily seen in platelet production, where iron deficiency anemia (IDA) leads to increased platelet production or thrombocytosis. This is achieved through increased megakaryopoietic differentiation. Nonetheless, little is known about the effect of iron deficiency on platelet function and the mechanism by which it happens. In addition to that, it is unknown whether iron deficiency in patient with an underlying bleeding disorder could mitigate worsening bleeding symptoms.
Studies in mice have demonstrated that platelet function was suppressed in iron-deficient mice, with evidence of iron-dependent platelet activation promoted through calcium mobilization and αIIbβ3 activation. A recent study in women with IDA demonstrated that iron levels may affect platelet function. Flow cytometry showed that women with IDA have quiescent platelets circulating in a degranulated state, which might be refractory to hemostatic activation. That same study showed that iron repletion decreased P-selectin levels and enhanced degranulation of quiescent platelets when exposed to CRP-XL or ADP. That translated into increased adhesion to collagen. A study done in children, adolescents, and young adults highlighted that mean PFA-100 closure times were significantly longer in patients with IDA, with reduced Platelet aggregation with ADP, epinephrine, and ristocetin. That same study showed that treatment with Iron improved platelet aggregation tests and significantly decreased PFA-100.
The clinical relationship between bleeding, platelet function, and iron deficiency remains poorly understood. It is hypothesized that patients with iron deficiency may experience increased bleeding, with anecdotal evidence suggesting that bleeding improves as iron levels are restored. This effect is believed to be mediated by alterations in platelet function. However, the specific cellular and molecular mechanisms underlying platelet hyporesponsiveness in iron deficiency are poorly elucidated. This would particularly impact patients with an underlying inherited bleeding disorder who are at an increased risk of blood loss.
This study addresses the critical gap in understanding the bleeding phenotype in iron-deficient patients with inherited bleeding disorders. To date, no studies have comprehensively evaluated this relationship. The investigator proposes a prospective study to assess bleeding phenotypes through validated bleeding assessment scores and quality of life metrics, pre and post IV iron replacement. Additionally, the investigator will analyze platelet samples pre- and post-treatment to investigate the impact of iron replenishment on platelet function and hemostatic parameters. These findings will provide valuable insights into the interplay between iron deficiency, platelet function, and bleeding severity, advancing our understanding and management of this unique patient population.
- Conditions
- Bleeding Disorders, Iron, Platelet, Bleeding
- Being tested
- IV Iron (standard of care)
- Keywords
- Iron deficiency, bleeding disorder, platelet function
- Medical subject headings
- Hemostatic Disorders, Hemorrhage, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Iron (standard of care)Drug
Participants will receive IV iron therapy as part of standard management for iron deficiency
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IV Iron (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bleeding assessment (ISTH-BAT score)
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
Measured: Baseline to 3 months post-IV iron replacement
Change in Menstrual Blood Loss (PBAC Score)
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.
Measured: Baseline to 3 months post-IV iron replacement
Change in Epistaxis Severity Score (ESS)
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.
Measured: Baseline to 3 months post-IV iron replacement
Secondary outcomes (9)
Change in Fatigue (FACIT-F Score)
Change in fatigue levels from baseline to 3 months after IV iron replacement, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F).
Score Range: 0 to 160
Scoring Interpretation: Lower scores indicate greater fatigue; higher scores indicate improved energy and well-being.
Measured: Baseline to 3 months post-IV iron replacement
Change in Physical Functioning (SF-36)
Change in physical functioning score on the SF-36 from baseline to 3 months post-IV iron.
Score Range: 0 to 100
Scoring Interpretation: Higher scores indicate better physical functioning.
Measured: Baseline to 3 months
Change in Role Limitations Due to Physical Health (SF-36)
Change in score from the Role Physical domain of the SF-36, which evaluates problems with work or daily activities due to physical health.
Score Range: 0 to 100
Scoring Interpretation: Higher scores reflect fewer role limitations.
Measured: Baseline to 3 months
Change in Role Limitations Due to Emotional Problems (SF-36)
Change in the Role Emotional domain score of the SF-36, which assesses limitations in daily activities due to emotional difficulties.
Score Range: 0 to 100
Scoring Interpretation: Higher scores indicate better emotional role functioning.
Measured: Baseline to 3 months
Change in the Vitality domain of the SF-36, measuring energy levels and fatigue.
Change in the Vitality domain of the SF-36, measuring energy levels and fatigue.
Score Range: 0 to 100
Scoring Interpretation: Higher scores indicate greater energy and less fatigue.
Measured: Baseline to 3 months
Change in Social Functioning (SF-36)
Change in the Social Functioning domain score, reflecting the extent to which physical or emotional health interferes with normal social activities.
Score Range: 0 to 100
Scoring Interpretation: Higher scores indicate better social functioning.
Measured: Baseline to 3 months
Change in Pain Score (SF-36)
Change in the Bodily Pain domain of the SF-36, evaluating intensity of pain and its effect on daily activities.
Score Range: 0 to 100
Scoring Interpretation: Higher scores indicate less pain and better pain management.
Measured: Baseline to 3 months
Change in Emotional Well-Being (SF-36)
Change in the Mental Health domain score of the SF-36, assessing psychological well-being, mood, and anxiety.
Score Range: 0 to 100
Scoring Interpretation: Higher scores indicate better emotional well-being.
Measured: Baseline to 3 months
Change in General Health Perception (SF-36)
Change in the General Health domain score of the SF-36, which assesses overall health perceptions.
Score Range: 0 to 100
Scoring Interpretation: Higher scores reflect better perceived general health.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start8 Aug 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Bleeding DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicoletta C Machin
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor-investigator, Nicoletta C Machin, University of Pittsburgh
- Investigators
- Nicoletta Machin, DO, Principal investigator, University of Pittburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083583
- Sponsor's protocol ID
- STUDY25020144
- Acronym
- IRON-BD
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share individual participant data (IPD) that underlie the results reported in the publication, after de-identification. This may include demographic data, primary and secondary outcomes, and relevant covariates. Data will be made available to researchers who provide a methodologically sound proposal for use in academic, non-commercial research. Proposals should be directed to machinnc2@upmc.edu. Access will be granted following approval by our institutional review board or ethics committee and the execution of a data use agreement. Data will be available beginning 6 months after publication and will remain accessible for 5 years.
Publications
McLaughlin JM, Munn JE, Anderson TL, Lambing A, Tortella B, Witkop ML. Predictors of quality of life among adolescents and young adults with a bleeding disorder. Health Qual Life Outcomes. 2017 Apr 7;15(1):67. doi: 10.1186/s12955-017-0643-7.
PubMed 28388906Kassebaum NJ, Jasrasaria R, Naghavi M, Wulf SK, Johns N, Lozano R, Regan M, Weatherall D, Chou DP, Eisele TP, Flaxman SR, Pullan RL, Brooker SJ, Murray CJ. A systematic analysis of global anemia burden from 1990 to 2010. Blood. 2014 Jan 30;123(5):615-24. doi: 10.1182/blood-2013-06-508325. Epub 2013 Dec 2.
PubMed 24297872VanderMeulen H, Sholzberg M. Iron deficiency and anemia in patients with inherited bleeding disorders. Transfus Apher Sci. 2018 Dec;57(6):735-738. doi: 10.1016/j.transci.2018.10.015. Epub 2018 Nov 17.
PubMed 30470664Lu Z, Machin NC. 2024. Assessment of bleeding severity and prevalence of iron deficiency among hemophilia b carriers by factor ix activity levels. Blood. 144(Supplement 1):2586-2586.
Chen YC, Chao TY, Cheng SN, Hu SH, Liu JY. Prevalence of von Willebrand disease in women with iron deficiency anaemia and menorrhagia in Taiwan. Haemophilia. 2008 Jul;14(4):768-74. doi: 10.1111/j.1365-2516.2008.01777.x. Epub 2008 May 17.
PubMed 18498402Park MJ, Park PW, Seo YH, Kim KH, Park SH, Jeong JH, Ahn JY. The relationship between iron parameters and platelet parameters in women with iron deficiency anemia and thrombocytosis. Platelets. 2013;24(5):348-51. doi: 10.3109/09537104.2012.699641. Epub 2012 Jun 27.
PubMed 22738419Liu S, Guo F, Zhang T, Zhu Y, Lu M, Wu X, He F, Yu R, Yan D, Ming Z, Shu D. Iron deficiency anemia and platelet dysfunction: A comprehensive analysis of the underlying mechanisms. Life Sci. 2024 Aug 15;351:122848. doi: 10.1016/j.lfs.2024.122848. Epub 2024 Jun 15.
PubMed 38885879Mokhtar GM, Ibrahim WE, Kassim NA, Ragab IA, Saad AA, Abdel Raheem HG. Alterations of platelet functions in children and adolescents with iron-deficiency anemia and response to therapy. Platelets. 2015;26(5):448-52. doi: 10.3109/09537104.2014.931570. Epub 2014 Jul 15.
PubMed 25026531Elstrott BK, Lakshmanan HHS, Melrose AR, Jordan KR, Martens KL, Yang CJ, Peterson DF, McMurry HS, Lavasseur C, Lo JO, Olson SR, DeLoughery TG, Aslan JE, Shatzel JJ. Platelet reactivity and platelet count in women with iron deficiency treated with intravenous iron. Res Pract Thromb Haemost. 2022 Mar 23;6(2):e12692. doi: 10.1002/rth2.12692. eCollection 2022 Feb.
PubMed 35356666Halimeh S, Rott H, Kappert G, Siebert M. 2013. Establishment of a reference range for the pbac-score. Blood. 122(21):4772-4772.
Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D; ISTH/SSC joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010 Sep;8(9):2063-5. doi: 10.1111/j.1538-7836.2010.03975.x. No abstract available.
PubMed 20626619
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders: a Single-arm Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07083583
- Acronym / sponsor ID
- IRON-BD / STUDY25020144
- Conditions
- Bleeding Disorders, Iron, Platelet, Bleeding
- Keywords
- Iron deficiency, bleeding disorder, platelet function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nicoletta C MachinUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Iron deficiency is one of the most prevalent nutritional deficiencies globally. In particular, patients with an inherited bleeding disorder are at increased risk of iron deficiency/ iron deficiency anemia given the propensity of this patient population to bleed. The impact of iron deficiency on hemoglobin synthesis is well established as it remains the leading cause of anemia worldwide, especially among menstruating women. Studies have shown a prevalence of iron deficiency as high as 93% in Hemophilia B Carriers , and iron deficiency anemia in 75% of females with von Willebrand Disease. However, platelets are also affected by iron deficiency. The effect of iron deficiency, as described in the past, is primarily seen in platelet production, where iron deficiency anemia (IDA) leads to increased platelet production or thrombocytosis. This is achieved through increased megakaryopoietic differentiation. Nonetheless, little is known about the effect of iron deficiency on platelet function and the mechanism by which it happens. In addition to that, it is unknown whether iron deficiency in patient with an underlying bleeding disorder could mitigate worsening bleeding symptoms.
Studies in mice have demonstrated that platelet function was suppressed in iron-deficient mice, with evidence of iron-dependent platelet activation promoted through calcium mobilization and αIIbβ3 activation. A recent study in women with IDA demonstrated that iron levels may affect platelet function. Flow cytometry showed that women with IDA have quiescent platelets circulating in a degranulated state, which might be refractory to hemostatic activation. That same study showed that iron repletion decreased P-selectin levels and enhanced degranulation of quiescent platelets when exposed to CRP-XL or ADP. That translated into increased adhesion to collagen. A study done in children, adolescents, and young adults highlighted that mean PFA-100 closure times were significantly longer in patients with IDA, with reduced Platelet aggregation with ADP, epinephrine, and ristocetin. That same study showed that treatment with Iron improved platelet aggregation tests and significantly decreased PFA-100.
The clinical relationship between bleeding, platelet function, and iron deficiency remains poorly understood. It is hypothesized that patients with iron deficiency may experience increased bleeding, with anecdotal evidence suggesting that bleeding improves as iron levels are restored. This effect is believed to be mediated by alterations in platelet function. However, the specific cellular and molecular mechanisms underlying platelet hyporesponsiveness in iron deficiency are poorly elucidated. This would particularly impact patients with an underlying inherited bleeding disorder who are at an increased risk of blood loss.
This study addresses the critical gap in understanding the bleeding phenotype in iron-deficient patients with inherited bleeding disorders. To date, no studies have comprehensively evaluated this relationship. The investigator proposes a prospective study to assess bleeding phenotypes through validated bleeding assessment scores and quality of life metrics, pre and post IV iron replacement. Additionally, the investigator will analyze platelet samples pre- and post-treatment to investigate the impact of iron replenishment on platelet function and hemostatic parameters. These findings will provide valuable insights into the interplay between iron deficiency, platelet function, and bleeding severity, advancing our understanding and management of this unique patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron Deficient patients with underlying bleeding disorders | – | Drug: IV Iron (standard of care)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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient in the outpatient setting with a bleeding disorder and Iron Deficiency planned for IV Iron as per Standard of care followed at the Hemophilia Center of Western Pennsylvania
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Previous thrombosis, VTE History.
- Platelet count < 100,000 * 109/L
- Concomitant use of antiplatelet drugs, anticoagulants, aspirin, NSAIDs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Iron (standard of care)Participants will receive IV iron therapy as part of standard management for iron deficiency | Drug | Iron Deficient patients with underlying bleeding disorders |
Primary outcome
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.
9 secondary outcomes
Change in Fatigue (FACIT-F Score)
Time frame: Baseline to 3 months post-IV iron replacement
Change in Physical Functioning (SF-36)
Time frame: Baseline to 3 months
Change in Role Limitations Due to Physical Health (SF-36)
Time frame: Baseline to 3 months
Change in Role Limitations Due to Emotional Problems (SF-36)
Time frame: Baseline to 3 months
Change in the Vitality domain of the SF-36, measuring energy levels and fatigue.
Time frame: Baseline to 3 months
Change in Social Functioning (SF-36)
Time frame: Baseline to 3 months
Change in Pain Score (SF-36)
Time frame: Baseline to 3 months
Change in Emotional Well-Being (SF-36)
Time frame: Baseline to 3 months
Change in General Health Perception (SF-36)
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 28388906McLaughlin JM, Munn JE, Anderson TL, Lambing A, Tortella B, Witkop ML. Predictors of quality of life among adolescents and young adults with a bleeding disorder. Health Qual Life Outcomes. 2017 Apr 7;15(1):67. doi: 10.1186/s12955-017-0643-7.
- Background: PubMed 24297872Kassebaum NJ, Jasrasaria R, Naghavi M, Wulf SK, Johns N, Lozano R, Regan M, Weatherall D, Chou DP, Eisele TP, Flaxman SR, Pullan RL, Brooker SJ, Murray CJ. A systematic analysis of global anemia burden from 1990 to 2010. Blood. 2014 Jan 30;123(5):615-24. doi: 10.1182/blood-2013-06-508325. Epub 2013 Dec 2.
- Background: PubMed 30470664VanderMeulen H, Sholzberg M. Iron deficiency and anemia in patients with inherited bleeding disorders. Transfus Apher Sci. 2018 Dec;57(6):735-738. doi: 10.1016/j.transci.2018.10.015. Epub 2018 Nov 17.
- BackgroundLu Z, Machin NC. 2024. Assessment of bleeding severity and prevalence of iron deficiency among hemophilia b carriers by factor ix activity levels. Blood. 144(Supplement 1):2586-2586.
- Background: PubMed 18498402Chen YC, Chao TY, Cheng SN, Hu SH, Liu JY. Prevalence of von Willebrand disease in women with iron deficiency anaemia and menorrhagia in Taiwan. Haemophilia. 2008 Jul;14(4):768-74. doi: 10.1111/j.1365-2516.2008.01777.x. Epub 2008 May 17.
- Background: PubMed 22738419Park MJ, Park PW, Seo YH, Kim KH, Park SH, Jeong JH, Ahn JY. The relationship between iron parameters and platelet parameters in women with iron deficiency anemia and thrombocytosis. Platelets. 2013;24(5):348-51. doi: 10.3109/09537104.2012.699641. Epub 2012 Jun 27.
- Background: PubMed 38885879Liu S, Guo F, Zhang T, Zhu Y, Lu M, Wu X, He F, Yu R, Yan D, Ming Z, Shu D. Iron deficiency anemia and platelet dysfunction: A comprehensive analysis of the underlying mechanisms. Life Sci. 2024 Aug 15;351:122848. doi: 10.1016/j.lfs.2024.122848. Epub 2024 Jun 15.
- Background: PubMed 25026531Mokhtar GM, Ibrahim WE, Kassim NA, Ragab IA, Saad AA, Abdel Raheem HG. Alterations of platelet functions in children and adolescents with iron-deficiency anemia and response to therapy. Platelets. 2015;26(5):448-52. doi: 10.3109/09537104.2014.931570. Epub 2014 Jul 15.
- Background: PubMed 35356666Elstrott BK, Lakshmanan HHS, Melrose AR, Jordan KR, Martens KL, Yang CJ, Peterson DF, McMurry HS, Lavasseur C, Lo JO, Olson SR, DeLoughery TG, Aslan JE, Shatzel JJ. Platelet reactivity and platelet count in women with iron deficiency treated with intravenous iron. Res Pract Thromb Haemost. 2022 Mar 23;6(2):e12692. doi: 10.1002/rth2.12692. eCollection 2022 Feb.
- BackgroundHalimeh S, Rott H, Kappert G, Siebert M. 2013. Establishment of a reference range for the pbac-score. Blood. 122(21):4772-4772.
- Background: PubMed 20626619Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D; ISTH/SSC joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010 Sep;8(9):2063-5. doi: 10.1111/j.1538-7836.2010.03975.x. No abstract available.
- Individual participant dataSharing planned: Yes. The investigators plan to share individual participant data (IPD) that underlie the results reported in the publication, after de-identification. This may include demographic data, primary and secondary outcomes, and relevant covariates. Data will be made available to researchers who provide a methodologically sound proposal for use in academic, non-commercial research. Proposals should be directed to machinnc2@upmc.edu. Access will be granted following approval by our institutional review board or ethics committee and the execution of a data use agreement. Data will be available beginning 6 months after publication and will remain accessible for 5 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicoletta Machin, DO principal investigator
University of Pittburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding Disorders and Iron, run by Nicoletta C Machin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicoletta Machin, DO ((412) 209-7280, MANCHINN@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bleeding assessment (ISTH-BAT score) (time frame: Baseline to 3 months post-IV iron replacement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07083583, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.