Clinical trial NCT03834727: Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
Official title: Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Bleeding Disorder
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: American Thrombosis and Hemostasis Network
First posted: 2019-02-08
Enrollment: 256
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women and girls receiving care at federally funded US Hemophilia Treatment Centers will be approached regarding participation.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool)
timeFrame: 1 year
measure: Reproductive tract bleeding will be characterized utilizing the Menstrual Bleeding Questionnaire.
timeFrame: 1 year
measure: Reproductive tract bleeding will be characterized by reviewing the medical history
timeFrame: 1 year
measure: Identify treatment strategies for heavy menstrual bleeding through patient report
timeFrame: 1 year
measure: Evaluate impact through quality of life tool (PROMIS-29)
timeFrame: 1 year
measure: Evaluate impact through quality of life tool (EQ-5D)
timeFrame: 1 year
measure: Evaluate the feasibility of entering female specific core data points to the ATHNdataset.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kristina Haley, DO
role: PRINCIPAL_INVESTIGATOR
References: