Changes in Bleeding and Clotting During the Menstrual Cycle

This study is currently recruiting participants.
Verified February 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Deborah Brown, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00480545
First received: May 29, 2007
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

Indirect evidence suggests that hormonal fluctuations during the menstrual cycle also affect the bleeding and clotting system. This study looks at two sensitive laboratory tests at four time points during the menstrual cycle to determine if there is a natural variation in coagulation and platelet function. Laboratory tests in healthy subjects will be compared to women with von Willebrand's disorder type 1, a bleeding disorder. In the future, these laboratory tests may help in the diagnosis of bleeding and clotting disorders and to design treatments for women with abnormal menstrual bleeding.


Condition
Von Willebrand's Disorder
Healthy

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 The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Endogenous Thrombin Potential [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Changes in coagulation as measured by ETP during the menstrual cycle


Secondary Outcome Measures:
  • von willebrand factor [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Changes in von Willebrand factor during the menstrual cycle


Biospecimen Retention:   Samples Without DNA

Blood samples will be discarded when the study is completed.


Estimated Enrollment: 40
Study Start Date: October 2005
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Von Willebrand disease (VWD) is the most common hereditary bleeding disorder, occurring in 1-2% of the population. Menorrhagia, or heavy menstrual bleeding, occurs in the majority of women with von Willebrand disease (VWD) and adversely affects quality of life. The American College of Obstetrics and Gynecology has recommended that women with heavy menstrual bleeding have diagnostic testing for VWD. Unfortunately, the diagnosis of VWD in women with menorrhagia can be difficult due to fluctuations in hemostatic protein levels during the menstrual cycle. The lack of useful coagulation assays has also limited the scope of pharmacokinetic studies and comparative clinical trials needed to determine best clinical practices in women with VWD.

Two new assay systems offer a possibility of increased sensitivity to physiologic variations in coagulation and fibrinolysis. The calibrated automated thrombin generation assay (TG), an estimation of endogenous thrombin potential (ETP), measures generation of thrombin throughout the entire process of coagulation and has appears to be very sensitive to small changes in levels of coagulation proteins. Thromboelastography (TEG) records clot formation and dissolution in whole blood samples providing a good marker for fibrinolysis. We propose that TG and TEG will be more sensitive than traditional coagulation assays to detect physiologic variations in hemostasis during the menstrual cycle and can accurately diagnose VWD. This is a single-institution pilot study to identify trends which are worthy of further exploration in a larger multi-institutional study. Our primary objective is to describe characteristics of TG and TEG at 4 time points during the menstrual cycle (days 0-3, 7-10, 14-17, and 21-24). Our secondary goal is to quantify the effects of VWD on TG and TEG at the same time points during the menstrual cycle and compare these to traditional coagulation assays.

This will be a single-institution pilot study of a total of 40 subjects: 20 healthy women and 20 women with VWD. Subjects must be female between the ages of 18 and 50 years, have regular menstrual periods, and not be pregnant. Women who are taking hormonal therapy, anti-fibrinolytic therapy, hemostatic agents or anti-platelet agents, will not be eligible for participation. Subjects will be given tampons and/or pads to use during one menstrual cycle. Study participation will involve a brief interview, completion of a questionnaire and a pictorial chart of one menstrual cycle, and having blood drawn at 4 time points during one menstrual cycle. Blood samples will be collected for TG and TEG and standard assays of coagulation and fibrinolysis. TG and TEG measurements will be compared to standard measures of coagulation, fibrinolysis, and platelet activation markers. Serum from the visit on day 21-24 will be tested for progesterone and Bhcg to confirm ovulation and exclude pregnancy. All assays will be performed at the Gulf States Hemophilia & Thrombophilia coagulation laboratory.

This study will result in an improved capability to diagnose women with VWD during the menstrual cycle. These new assays may be useful in the rational design of therapeutic agents and clinical trials. In addition, the physiologic basis of variations in coagulation during the menstrual cycle can be explored in future studies using this assay system.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women aged 18 to 50 years with regular menstrual cycles.

Criteria

Inclusion Criteria:

  • Must be female
  • Aged 18 to 50 years, with regular menstrual cycles.
  • Healthy volunteers and women with von Willebrand's disorder are both being recruited.

Exclusion Criteria:

  • Pregnancy
  • Use of hormonal therapy including birth control pills
  • Use of hemostatic agents such as DDAVP or anti-platelet agents.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480545

Contacts
Contact: madeline Cantini, BSN 713-500-8377 madeline.cantini@uth.tmc.edu
Contact: kathryn moynihan, BSN 713-500-8376 kathryn.l.moynihan@uth.tmc.edu

Locations
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: madeline cantini, BSN    713-500-8377    madeline.cantini@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Deborah L. Brown, M.D. University of Texas Health Science Center in Houston
  More Information

No publications provided

Responsible Party: Deborah Brown, Associate Professor - Gulf States Hemophilia Center, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00480545     History of Changes
Other Study ID Numbers: HSC-MS-05-0095
Study First Received: May 29, 2007
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Women with bleeding disorders
Menstrual cycle
Women
Healthy volunteers

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

ClinicalTrials.gov processed this record on April 20, 2014