Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

NCT00178542 | Terminated

• 1 other identifier: TG and TEG
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Von Willebrand Disease

Keywords

von Willebrand Disease; Healthy Women and Women with von Willebrand Disease

Outcome Measures

Primary Outcomes (1)

• Endogenous Thrombin Potential

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

  4 weeks

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Females with a diagnosis of von Willebrand Disease

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• The ZLB Behring Foundation: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Deborah Brown, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profess - Gulf States Hemophilia Center

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2005
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

US (1)