Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2013-04-30

Brief Summary

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The primary objective of this study is to describe characteristics and trends for thrombin generation (TG) and thromboelastography (TEG) at 4 time points during the menstrual cycle.

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Detailed Description

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We propose that TG and TEG will be more sensitive than traditional coagulation assays to detect physiologic variation in hemostasis, fibrinolysis, and platelet activation throughout the menstrual cycle. We expect that TG and TEG will better discriminate patients with vWD than traditional coagulation studies during the menstrual cycle. In this study we plan to measure TG and TEG in healthy women and women with von Willebrand's disorder during four phases of the menstrual cycle. We will compare specific measurements of endogenous thrombin generation potential from the TG and fibrinolysis and platelet activation from the TEG with standard measures of coagulation, fibrinolysis, and platelet activation markers during the menstrual cycle.

Conditions

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Von Willebrand Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Females of reproductive age with regular menstrual cycles and a diagnosis of von Willebrand disease according to the International Society of Thrombosis and Hemostasis diagnostic criteria.

Exclusion Criteria

* Females who are pregnant, or have a history of endocrinopathy or hormone imbalance
* History of hysterectomy or bilateral oophorectomy
* History of ovarian or uterine cancer
* Use of intrauterine device
* Use of antifibrinolytic therapy, hemostatic agents, or anti-platelet agents.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No