Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

Changes in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00178542

Enrollment

Registered

2005-09-15

Start date

2005-09-30

Completion date

2013-04-30

Last updated

2013-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Von Willebrand Disease

Keywords

von Willebrand Disease, Healthy Women and Women with von Willebrand Disease

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Endogenous Thrombin Potential	4 weeks	Comparison of 4 values collected during 4 phases of through the menstrual cycle

Countries

United States

Outcome results