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TerminatedNCT00178542Updated May 6, 2013

Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

An observational study in Von Willebrand Disease, sponsored by The University of Texas Health Science Center, Houston. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-05-06.

Sponsored by The University of Texas Health Science Center, Houston · Observational

Why this study was terminated
Insufficient enrollment
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • Von Willebrand Disease

Keywords

  • von Willebrand Disease
  • Healthy Women and Women with von Willebrand Disease
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In context

Von Willebrand Diseases

63 studies on the registry are indexed under Von Willebrand Diseases; 4 are open to participants now.

This study's enrollment of 20 is below the median of 102 across 31 observational studies indexed under Von Willebrand Diseases.

Browse Von Willebrand Diseases studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Females with a diagnosis of von Willebrand Disease

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)
06

What researchers measure

Primary outcomes

  1. Endogenous Thrombin Potential

    Comparison of 4 values collected during 4 phases of through the menstrual cycle

    Time frame: 4 weeks

07

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00178542
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
The ZLB Behring Foundation
Responsible party
Deborah Brown (Associate Profess - Gulf States Hemophilia Center, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Sep 15, 2005
Start date
Sep 2005
Primary completion
Apr 2013
Completion
Apr 2013
Last update
May 6, 2013

Study contacts

Deborah Brown, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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