Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
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ClinicalTrials.gov Identifier: NCT00178542
: September 15, 2005
Last Update Posted
: May 6, 2013
The University of Texas Health Science Center, Houston
The ZLB Behring Foundation
Information provided by (Responsible Party):
Deborah Brown, The University of Texas Health Science Center, Houston
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.
Condition or disease
Von Willebrand Disease
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.
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Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Females with a diagnosis of von Willebrand Disease
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.
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.