<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03834727</url>
  </required_header>
  <id_info>
    <org_study_id>00018857</org_study_id>
    <nct_id>NCT03834727</nct_id>
  </id_info>
  <brief_title>Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders</brief_title>
  <official_title>Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Thrombosis and Hemostasis Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Characterizing the impact and treatment of reproductive tract bleeding on women and&#xD;
      post-menarchal girls with bleeding disorders.&#xD;
&#xD;
      Objectives: This is a cross-sectional observational study of women and girls (WG) with&#xD;
      bleeding disorders enrolled in the American Thrombosis and Hemostasis Network (ATHN) dataset.&#xD;
      Based on the investigators' study of currently available data of WG with bleeding disorders&#xD;
      in the ATHNdataset, the investigators hypothesize that the information currently captured in&#xD;
      the core data elements of the ATHNdatasest does not adequately capture data specific to WG&#xD;
      with bleeding disorders. Further, the investigators hypothesize that it is feasible for&#xD;
      Hemophilia Treatment Centers (HTCs) to include data points specific to WG with bleeding&#xD;
      disorder when enrolling participants in the ATHNdataset. This hypothesis will be evaluated&#xD;
      through the following specific aims:&#xD;
&#xD;
      Specific Aim 1: Characterize reproductive tract bleeding in a cohort of WG with bleeding&#xD;
      disorders cared for at US HTCs.&#xD;
&#xD;
      Specific Aim 2: Characterize the treatment strategies for and the impact of heavy menstrual&#xD;
      bleeding in a cohort of females with bleeding disorders cared for at HTCs.&#xD;
&#xD;
      Specific Aim 3: Evaluate the feasibility of adding female specific core data points to the&#xD;
      ATHNdataset.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, cross-sectional study of women and girls with bleeding disorders&#xD;
      receiving care at Hemophilia Treatment Centers (HTCs). To further characterize this&#xD;
      population, WG who receive care at federally funded US HTCs will be approached regarding&#xD;
      participation. Following assent and/or consent, participants will be asked to complete a&#xD;
      series of forms. In order to assess their bleeding symptoms, they will complete the self-BAT&#xD;
      (Bleeding Assessment Tool) as well as the Menstrual Bleeding Questionnaire (MBQ). In order to&#xD;
      assess their quality of life, they will complete the PROMIS-29 quality of life inventories.&#xD;
      Patients may be contacted if they miss a question on any of these forms. Phone call should&#xD;
      take no more than 15 minutes. Study staff will complete an intake form which includes data&#xD;
      regarding bleeding disorder diagnosis as well as treatment, using information obtained from&#xD;
      the patient, chart review, and the ATHNdataset.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2018</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool)</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reproductive tract bleeding will be characterized utilizing the Menstrual Bleeding Questionnaire.</measure>
    <time_frame>1 year</time_frame>
    <description>The Menstrual Bleeding Questionnaire is a patient reported outcome tool specific to the symptom of menstrual bleeding. It is also self-administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reproductive tract bleeding will be characterized by reviewing the medical history</measure>
    <time_frame>1 year</time_frame>
    <description>Utilizing the current ATHNdataset data forms, the medical history will be reviewed and symptoms and diagnoses specific to menstrual bleeding will be entered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify treatment strategies for heavy menstrual bleeding through patient report</measure>
    <time_frame>1 year</time_frame>
    <description>Utilizing a form previously developed, participants will indicate previous treatments utilized for heavy menstrual bleeding and rank their effectiveness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate impact through quality of life tool (PROMIS-29)</measure>
    <time_frame>1 year</time_frame>
    <description>Participants will complete the PROMIS-29 quality of life tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate impact through quality of life tool (EQ-5D)</measure>
    <time_frame>1 year</time_frame>
    <description>Participants will complete the EQ-5D quality of life tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the feasibility of entering female specific core data points to the ATHNdataset.</measure>
    <time_frame>1 year</time_frame>
    <description>Study site coordinators will complete a feasibility questionnaire regarding the challenges of adding female specific data to the ATHNdataset.</description>
  </primary_outcome>
  <enrollment type="Actual">256</enrollment>
  <condition>Hemophilia A</condition>
  <condition>Bleeding Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Women and girls receiving care at federally funded US Hemophilia Treatment Centers will be&#xD;
        approached regarding participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women and girls with an active diagnosis of a congenital bleeding disorder (as&#xD;
             designated by the institution inputting data);&#xD;
&#xD;
               1. Deficiencies of factors VIII, IX, II, V, VII, VII, IX, X, XI, FV+VIII, XIII,&#xD;
                  Plasminogen Activator Inhibitor 1(PAI-1), hypo-, a-, or dys-fibrinogenemia&#xD;
&#xD;
               2. von Willebrand Disease (Type 1, Type 1c, Type 2A, Type 2B, Type 2M, Type 2N, Type&#xD;
                  3, Low VWF)&#xD;
&#xD;
               3. Any platelet function disorder (i.e. Glanzmann Thrombasthenia, Bernard Soulier&#xD;
                  Syndrome, Platelet Storage Pool disorder, MYH9 disorders, Gray Platelet syndrome,&#xD;
                  Dense granule deficiency)&#xD;
&#xD;
               4. Ehlers Danlos Syndrome&#xD;
&#xD;
          -  Post-menarchal: has had at least 1 period at the time of study entry&#xD;
&#xD;
          -  Participating in the ATHNdataset&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male gender&#xD;
&#xD;
          -  Acquired bleeding disorder&#xD;
&#xD;
          -  Thrombotic disorder&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristina Haley, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>April 14, 2023</last_update_submitted>
  <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Kristina Haley</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Hemophilia A</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Hemorrhagic Disorders</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03834727
org study id: 00018857
nct id: NCT03834727
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Cross-Sectional
measure: Reproductive tract bleeding will be characterized utilizing the ISTH-BAT(International Society of Thrombosis and Haemostasis Bleeding Assessment Tool)
time frame: 1 year
description: 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.
measure: Reproductive tract bleeding will be characterized utilizing the Menstrual Bleeding Questionnaire.
time frame: 1 year
description: The Menstrual Bleeding Questionnaire is a patient reported outcome tool specific to the symptom of menstrual bleeding. It is also self-administered.
measure: Reproductive tract bleeding will be characterized by reviewing the medical history
time frame: 1 year
description: Utilizing the current ATHNdataset data forms, the medical history will be reviewed and symptoms and diagnoses specific to menstrual bleeding will be entered.
measure: Identify treatment strategies for heavy menstrual bleeding through patient report
time frame: 1 year
description: Utilizing a form previously developed, participants will indicate previous treatments utilized for heavy menstrual bleeding and rank their effectiveness.
measure: Evaluate impact through quality of life tool (PROMIS-29)
time frame: 1 year
description: Participants will complete the PROMIS-29 quality of life tool.
measure: Evaluate impact through quality of life tool (EQ-5D)
time frame: 1 year
description: Participants will complete the EQ-5D quality of life tool.
measure: Evaluate the feasibility of entering female specific core data points to the ATHNdataset.
time frame: 1 year
description: Study site coordinators will complete a feasibility questionnaire regarding the challenges of adding female specific data to the ATHNdataset.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 10 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kristina Haley, DO
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Kristina Haley
investigator title: Associate Professor
mesh term: Hemostatic Disorders
mesh term: Hemophilia A
mesh term: Blood Coagulation Disorders
mesh term: Hemorrhagic Disorders
mesh term: Hemorrhage