Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

Terminated

• Conditions: Von Willebrand Disease

• Registration Number: NCT00178542
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-03
• Last Update Posted: 2013-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endogenous Thrombin Potential	4 weeks	Comparison of 4 values collected during 4 phases of through the menstrual cycle

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States