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Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

This study has been terminated.
(Insufficient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178542
First Posted: September 15, 2005
Last Update Posted: May 6, 2013
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.
Collaborator:
The ZLB Behring Foundation
Information provided by (Responsible Party):
Deborah Brown, The University of Texas Health Science Center, Houston
  Purpose
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
Von Willebrand Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Changes in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

Resource links provided by NLM:


Further study details as provided by Deborah Brown, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Endogenous Thrombin Potential [ Time Frame: 4 weeks ]
    Comparison of 4 values collected during 4 phases of through the menstrual cycle


Enrollment: 20
Study Start Date: September 2005
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Females with a diagnosis of von Willebrand Disease
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178542


Locations
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
The ZLB Behring Foundation
Investigators
Principal Investigator: Deborah Brown, MD The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Deborah Brown, Associate Profess - Gulf States Hemophilia Center, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178542     History of Changes
Other Study ID Numbers: TG and TEG
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: May 6, 2013
Last Verified: May 2013

Keywords provided by Deborah Brown, The University of Texas Health Science Center, Houston:
von Willebrand Disease
Healthy Women and Women with von Willebrand Disease

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Thrombin
Hemostatics
Coagulants