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NCT03834727 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Oregon Health and Science University.

Completed
Registry status
256
Enrollment target

NCT03834727: Completed study, sponsored by Oregon Health and Science University.

NCT03834727 is a clinical trial that has completed, run by Oregon Health and Science University. The registered enrollment target is 256 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03834727 has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
256 participants
Enrollment target

Study 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.

Primary Outcome

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.

Trial Details

FieldValue
Enrollment Target 256 participants
Start Date 2018-09-05
Est. Completion 2022-04-01

What the finished NCT03834727 record still lists

NCT03834727 is an observational study that tracks outcomes without assigning an intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT03834727 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03834727 about?

NCT03834727 is a clinical study titled "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 (ATH...

What is the current status of trial NCT03834727?

This trial is currently completed. The enrollment target is 256 participants. The study started on 2018-09-05. Estimated completion is 2022-04-01.

Who is sponsoring clinical trial NCT03834727?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03834727, the US trial registry maintained by the National Library of Medicine. NCT03834727 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.