Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders

Hemophilia A Clinical Trial

Official title:

Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834727
• Other study ID #: 00018857
• Status: Completed
• Start date: September 5, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women and girls with an active diagnosis of a congenital bleeding disorder (as designated by the institution inputting data);

1. 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

2. von Willebrand Disease (Type 1, Type 1c, Type 2A, Type 2B, Type 2M, Type 2N, Type 3, Low VWF)

3. Any platelet function disorder (i.e. Glanzmann Thrombasthenia, Bernard Soulier Syndrome, Platelet Storage Pool disorder, MYH9 disorders, Gray Platelet syndrome, Dense granule deficiency)

4. Ehlers Danlos Syndrome

• Post-menarchal: has had at least 1 period at the time of study entry
• Participating in the ATHNdataset

Exclusion Criteria:

• Male gender
• Acquired bleeding disorder
• Thrombotic disorder
• Non-English speaking

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Hemophilia A
• Hemorrhage
• Hemorrhagic Disorders
• Hemostatic Disorders

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	American Thrombosis and Hemostasis Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	Evaluate impact through quality of life tool (PROMIS-29)	Participants will complete the PROMIS-29 quality of life tool.	1 year
Primary	Evaluate impact through quality of life tool (EQ-5D)	Participants will complete the EQ-5D quality of life tool.	1 year
Primary	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.	1 year