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

Brief Title

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.

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.

Study Type

Observational [Patient Registry]

Primary Outcome

Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool)

Condition

Hemophilia A

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

September 5, 2018

Completion Date

January 1, 2022

Primary Completion Date

November 1, 2021

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

Gender

Female

Ages

10 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Kristina Haley, DO, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03834727

Organization ID

00018857

Responsible Party

Principal Investigator

Study Sponsor

Oregon Health and Science University

Collaborators

 American Thrombosis and Hemostasis Network

Study Sponsor

Kristina Haley, DO, Principal Investigator, Oregon Health and Science University

Verification Date

February 2021