Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

Von Willebrand Disease Clinical Trial

Official title:

Changes in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00178542
• Other study ID #: TG and TEG
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 3, 2013
• Start date: September 2005
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Von Willebrand Disease
• Von Willebrand Diseases

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	The ZLB Behring Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endogenous Thrombin Potential	Comparison of 4 values collected during 4 phases of through the menstrual cycle	4 weeks	No