Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00178542
Recruitment Status :
First Posted : 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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.