Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
This study has been terminated.
The ZLB Behring Foundation
Information provided by (Responsible Party):
Deborah Brown, The University of Texas Health Science Center, Houston
First received: September 12, 2005
Last updated: May 3, 2013
Last verified: May 2013
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Changes in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders 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.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178542
|The University of Texas Health Science Center at Houston
|Houston, Texas, United States, 77030 |
The University of Texas Health Science Center, Houston
The ZLB Behring Foundation
||Deborah Brown, MD
||The University of Texas Health Science Center, Houston
No publications provided
||Deborah Brown, Associate Profess - Gulf States Hemophilia Center, The University of Texas Health Science Center, Houston
History of Changes
|Other Study ID Numbers:
||TG and TEG
|Study First Received:
||September 12, 2005
||May 3, 2013
||United States: Institutional Review Board
Keywords provided by The University of Texas Health Science Center, Houston:
von Willebrand Disease
Healthy Women and Women with von Willebrand Disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Von Willebrand Diseases
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Coagulation Protein Disorders
Genetic Diseases, Inborn