Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00178542
Other study ID # TG and TEG
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Withdrawn NCT01651468 - The Effect of the Nutraceutical "Hemofix" on the Coagulation System N/A
Active, not recruiting NCT00555555 - Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients Phase 4
Completed NCT02552576 - Study of Voncento® in Subjects With Von Willebrand Disease Phase 4
Recruiting NCT02869074 - Molecular and Clinical Profile of Von Willebrand Disease in Spain
Completed NCT01602419 - Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease
Completed NCT01224808 - Extension Study of Biostate in Subjects With Von Willebrand Disease Phase 3
Completed NCT00805051 - Acquired Von Willebrand Syndrome in Severe Aortic Stenosis N/A
Withdrawn NCT00694785 - A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B Phase 2
Completed NCT02246881 - A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A. Phase 3
Completed NCT00168090 - Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD) Phase 4
Completed NCT04657887 - Registry of Patients With Von WilLEbrand Disease Treated With Voncento®
Withdrawn NCT00630448 - Collection of Blood in Normal Subjects and Subjects With Von Willebrand Disease (VWD) N/A
Terminated NCT00387192 - A Study With OPTIVATE® in People With Von Willebrand Disease Phase 3
Completed NCT02973087 - rVWF IN PROPHYLAXIS Phase 3
Completed NCT01410227 - Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD) Phase 3
Completed NCT01949220 - Willebrand International Non-interventional Global Surveillance
Completed NCT01589848 - Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador N/A
Completed NCT00941616 - Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease Phase 2/Phase 3
Completed NCT00557908 - The Von Willebrand Disease (VWD) International Prophylaxis Study N/A
Active, not recruiting NCT04953884 - Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age Phase 3