Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

The University of Texas System (UT)

Status: Terminated

Conditions: Von Willebrand Disease

Study type: Observational

Funder types: Other

Identifiers

NCT00178542

TG and TEG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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.