Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Anemia, Hematology, Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 10 - 65 |
| Updated: | 2/10/2019 |
| Start Date: | September 5, 2018 |
| End Date: | September 4, 2019 |
Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders.
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.
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.
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.
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
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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