Hemophilia ANCT03834727
Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
An observational study of Hemophilia A and Bleeding Disorder, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Characterizing the impact and treatment of reproductive tract bleeding on women and post-menarchal girls with bleeding disorders. Objectives: This is a cross-sectional observational study of women and girls (WG) with bleeding disorders enrolled in the American Thrombosis and Hemostasis Network (ATHN) dataset. Read more about this study
- Who is it for?
- Ages 10 to 65 years, women only
- Conditions the study is for
- Hemophilia A, Bleeding Disorder
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 1 Apr 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women and girls receiving care at federally funded US Hemophilia Treatment Centers will be approached regarding participation.
Who may be able to join
- Women and girls with an active diagnosis of a congenital bleeding disorder (as designated by the institution inputting data);
- Deficiencies of factors VIII, IX, II, V, VII, VII, IX, X, XI, FV+VIII, XIII, Plasminogen Activator Inhibitor 1(PAI-1), hypo-, a-, or dys-fibrinogenemia
- von Willebrand Disease (Type 1, Type 1c, Type 2A, Type 2B, Type 2M, Type 2N, Type 3, Low VWF)
- Any platelet function disorder (i.e. Glanzmann Thrombasthenia, Bernard Soulier Syndrome, Platelet Storage Pool disorder, MYH9 disorders, Gray Platelet syndrome, Dense granule deficiency)
- Ehlers Danlos Syndrome
- Post-menarchal: has had at least 1 period at the time of study entry
- Participating in the ATHNdataset
Who cannot join
- Male gender
- Acquired bleeding disorder
- Thrombotic disorder
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.
Characterizing the impact and treatment of reproductive tract bleeding on women and post-menarchal girls with bleeding disorders.
Objectives: This is a cross-sectional observational study of women and girls (WG) with bleeding disorders enrolled in the American Thrombosis and Hemostasis Network (ATHN) dataset. Based on the investigators' study of currently available data of WG with bleeding disorders in the ATHNdataset, the investigators hypothesize that the information currently captured in the core data elements of the ATHNdatasest does not adequately capture data specific to WG with bleeding disorders. Further, the investigators hypothesize that it is feasible for Hemophilia Treatment Centers (HTCs) to include data points specific to WG with bleeding disorder when enrolling participants in the ATHNdataset. This hypothesis will be evaluated through the following specific aims:
Read more
Specific Aim 1: Characterize reproductive tract bleeding in a cohort of WG with bleeding disorders cared for at US HTCs.
Specific Aim 2: Characterize the treatment strategies for and the impact of heavy menstrual bleeding in a cohort of females with bleeding disorders cared for at HTCs.
Specific Aim 3: Evaluate the feasibility of adding female specific core data points to the ATHNdataset.
Read the detailed description
This is a multi-center, cross-sectional study of women and girls with bleeding disorders receiving care at Hemophilia Treatment Centers (HTCs). To further characterize this population, WG who receive care at federally funded US HTCs will be approached regarding participation. Following assent and/or consent, participants will be asked to complete a series of forms. In order to assess their bleeding symptoms, they will complete the self-BAT (Bleeding Assessment Tool) as well as the Menstrual Bleeding Questionnaire (MBQ). In order to assess their quality of life, they will complete the PROMIS-29 quality of life inventories. Patients may be contacted if they miss a question on any of these forms. Phone call should take no more than 15 minutes. Study staff will complete an intake form which includes data regarding bleeding disorder diagnosis as well as treatment, using information obtained from the patient, chart review, and the ATHNdataset.
- Conditions
- Hemophilia A, Bleeding Disorder
- Medical subject headings
- Hemophilia A, Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool)
The ISTH-BAT is the International Society on Thrombosis and Hemostasis Bleeding Assessment Tool and can be self-administered. It provides an overall bleeding score as well as information about specific bleeding symptoms.
Measured: 1 year
Reproductive tract bleeding will be characterized utilizing the Menstrual Bleeding Questionnaire.
The Menstrual Bleeding Questionnaire is a patient reported outcome tool specific to the symptom of menstrual bleeding. It is also self-administered.
Measured: 1 year
Reproductive tract bleeding will be characterized by reviewing the medical history
Utilizing the current ATHNdataset data forms, the medical history will be reviewed and symptoms and diagnoses specific to menstrual bleeding will be entered.
Measured: 1 year
Identify treatment strategies for heavy menstrual bleeding through patient report
Utilizing a form previously developed, participants will indicate previous treatments utilized for heavy menstrual bleeding and rank their effectiveness.
Measured: 1 year
Evaluate impact through quality of life tool (PROMIS-29)
Participants will complete the PROMIS-29 quality of life tool.
Measured: 1 year
Evaluate impact through quality of life tool (EQ-5D)
Participants will complete the EQ-5D quality of life tool.
Measured: 1 year
Evaluate the feasibility of entering female specific core data points to the ATHNdataset.
Study site coordinators will complete a feasibility questionnaire regarding the challenges of adding female specific data to the ATHNdataset.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start5 Sep 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 256 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- American Thrombosis and Hemostasis Network
- Responsible party
- Principal investigator, Kristina Haley, Oregon Health and Science University
- Investigators
- Kristina Haley, DO, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834727
- Sponsor's protocol ID
- 00018857
- Status last verified
- Apr 2023
- First submitted
- 18 Dec 2018
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.
- ClinicalTrials.gov ID
- NCT03834727
- Acronym / sponsor ID
- 00018857
- Conditions
- Hemophilia A, Bleeding Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- American Thrombosis and Hemostasis Network
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 8 Feb 2019 (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.
Characterizing the impact and treatment of reproductive tract bleeding on women and post-menarchal girls with bleeding disorders.
Objectives: This is a cross-sectional observational study of women and girls (WG) with bleeding disorders enrolled in the American Thrombosis and Hemostasis Network (ATHN) dataset. Based on the investigators' study of currently available data of WG with bleeding disorders in the ATHNdataset, the investigators hypothesize that the information currently captured in the core data elements of the ATHNdatasest does not adequately capture data specific to WG with bleeding disorders. Further, the investigators hypothesize that it is feasible for Hemophilia Treatment Centers (HTCs) to include data points specific to WG with bleeding disorder when enrolling participants in the ATHNdataset. This hypothesis will be evaluated through the following specific aims:
Specific Aim 1: Characterize reproductive tract bleeding in a cohort of WG with bleeding disorders cared for at US HTCs.
Specific Aim 2: Characterize the treatment strategies for and the impact of heavy menstrual bleeding in a cohort of females with bleeding disorders cared for at HTCs.
Specific Aim 3: Evaluate the feasibility of adding female specific core data points to the ATHNdataset.
Detailed description
This is a multi-center, cross-sectional study of women and girls with bleeding disorders receiving care at Hemophilia Treatment Centers (HTCs). To further characterize this population, WG who receive care at federally funded US HTCs will be approached regarding participation. Following assent and/or consent, participants will be asked to complete a series of forms. In order to assess their bleeding symptoms, they will complete the self-BAT (Bleeding Assessment Tool) as well as the Menstrual Bleeding Questionnaire (MBQ). In order to assess their quality of life, they will complete the PROMIS-29 quality of life inventories. Patients may be contacted if they miss a question on any of these forms. Phone call should take no more than 15 minutes. Study staff will complete an intake form which includes data regarding bleeding disorder diagnosis as well as treatment, using information obtained from the patient, chart review, and the ATHNdataset.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 10 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women and girls receiving care at federally funded US Hemophilia Treatment Centers will be approached regarding participation.
Key inclusion criteria (7 listed)
- Women and girls with an active diagnosis of a congenital bleeding disorder (as designated by the institution inputting data);
- Post-menarchal: has had at least 1 period at the time of study entry
- Participating in the ATHNdataset
Key exclusion criteria (4 listed)
- Male gender
- Acquired bleeding disorder
- Thrombotic disorder
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool)
Time frame: 1 year
The ISTH-BAT is the International Society on Thrombosis and Hemostasis Bleeding Assessment Tool and can be self-administered. It provides an overall bleeding score as well as information about specific bleeding symptoms.
Reproductive tract bleeding will be characterized utilizing the Menstrual Bleeding Questionnaire.
Time frame: 1 year
The Menstrual Bleeding Questionnaire is a patient reported outcome tool specific to the symptom of menstrual bleeding. It is also self-administered.
Reproductive tract bleeding will be characterized by reviewing the medical history
Time frame: 1 year
Utilizing the current ATHNdataset data forms, the medical history will be reviewed and symptoms and diagnoses specific to menstrual bleeding will be entered.
Identify treatment strategies for heavy menstrual bleeding through patient report
Time frame: 1 year
Utilizing a form previously developed, participants will indicate previous treatments utilized for heavy menstrual bleeding and rank their effectiveness.
Evaluate impact through quality of life tool (PROMIS-29)
Time frame: 1 year
Participants will complete the PROMIS-29 quality of life tool.
Evaluate impact through quality of life tool (EQ-5D)
Time frame: 1 year
Participants will complete the EQ-5D quality of life tool.
Evaluate the feasibility of entering female specific core data points to the ATHNdataset.
Time frame: 1 year
Study site coordinators will complete a feasibility questionnaire regarding the challenges of adding female specific data to the ATHNdataset.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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. This study is not recruiting at the moment.
Kristina Haley, DO principal investigator
Oregon Health and Science University
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 Hemophilia A and Bleeding Disorder, run by Oregon Health and Science University 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 18 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool) (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.