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Trial record 43 of 456 for:    Inherited Bleeding Disorder

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

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ClinicalTrials.gov Identifier: NCT03834727
Recruitment Status : Enrolling by invitation
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
American Thrombosis and Hemostasis Network
Information provided by (Responsible Party):
Kristina Haley, Oregon Health and Science University

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.


Condition or disease
Hemophilia A Bleeding Disorder

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : September 4, 2019
Estimated Study Completion Date : September 4, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Evaluate impact through quality of life tool (PROMIS-29) [ Time Frame: 1 year ]
    Participants will complete the PROMIS-29 quality of life tool.

  6. Evaluate impact through quality of life tool (EQ-5D) [ Time Frame: 1 year ]
    Participants will complete the EQ-5D quality of life tool.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women and girls receiving care at federally funded US Hemophilia Treatment Centers will be approached regarding participation.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834727


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
American Thrombosis and Hemostasis Network
Investigators
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Principal Investigator: Kristina Haley, DO Oregon Health and Science University

Additional Information:

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Responsible Party: Kristina Haley, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03834727     History of Changes
Other Study ID Numbers: 00018857
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Disease
Hemorrhage
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Hemophilia A
Pathologic Processes