Advertisement

Topics

Changes in Bleeding and Clotting During the Menstrual Cycle

2014-08-27 03:38:14 | BioPortfolio

Summary

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.

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Conditions

Von Willebrand's Disorder

Location

University of Texas Health Science Center at Houston
Houston
Texas
United States
77030

Status

Recruiting

Source

The University of Texas Health Science Center, Houston

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:14-0400

Clinical Trials [507 Associated Clinical Trials listed on BioPortfolio]

Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease

OBJECTIVES: I. Evaluate the effect of a new von Willebrand factor concentrate on bleeding time, in vivo recovery, and circulating half-life of the infused factor in patients with von Will...

Low Von Willebrand in Ireland Cohort Study

The Low Von Willebrand in Ireland Cohort (LoVIC) study focuses on the bleeding phenotype and biological mechanisms underlying low Von Willebrand Factor (VWF) levels.

Collection of Blood in Normal Subjects and Subjects With Von Willebrand Disease (VWD)

Von Willebrand disease is an inherited bleeding disorder that impacts the blood's ability to clot properly. Von Willebrand disease is cause by the lack or not working substance in the bloo...

National Study of Moderate and Severe Von Willebrand Disease in the Netherlands

The objective of this study is to assess the clinical presentation, the treatment and the complications of the disease and treatment in moderate and severe von Willebrand disease. Another ...

rVWF IN PROPHYLAXIS

The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity and thrombogenicity of prophylactic treatment with recombinant von Willebrand factor (...

PubMed Articles [4300 Associated PubMed Articles listed on BioPortfolio]

A case report on the successful perioperative management of hepatectomy for hepatocellular carcinoma in a patient with von Willebrand disease.

Although von Willebrand disease (VWD) is a common inherited bleeding disorder, very few cases of surgery in patients with VWD have been reported.

Comprehensive re-evaluation of historical von Willebrand disease diagnosis in association with whole blood platelet aggregation and function.

Diagnosis of von Willebrand disease (VWD) is challenging, particularly for type 1. The current diagnostic guidelines emphasize simultaneous bleeding symptoms and von Willebrand factor (VWF) levels of

High and long-term von Willebrand factor expression after Sleeping Beauty transposon-mediated gene therapy in a mouse model of severe von Willebrand disease.

Type 3 von Willebrand disease (VWD) is characterized by complete absence of von Willebrand factor (VWF). Current therapy is limited to treatment with exogenous VWF/FVIII products, which only provide a...

Revascularization operation for moyamoya disease with concurrent von Willebrand disease: A case report.

Although extracranial-intracranial (EC-IC) bypass is an effective treatment strategy for symptomatic moyamoya disease, surgeons need to be cautious regarding the possibility of postoperative hemorrhag...

The increasing maturity of the von Willebrand factor collagen binding in von Willebrand disease diagnosis.

Medical and Biotech [MESH] Definitions

A subtype of von Willebrand disease that results from a partial deficiency of VON WILLEBRAND FACTOR.

A subtype of von Willebrand disease that results from qualitative deficiencies of VON WILLEBRAND FACTOR. The subtype is divided into several variants with each variant having a distinctive pattern of PLATELET-interaction.

A high-molecular-weight plasma protein, produced by endothelial cells and megakaryocytes, that is part of the factor VIII/von Willebrand factor complex. The von Willebrand factor has receptors for collagen, platelets, and ristocetin activity as well as the immunologically distinct antigenic determinants. It functions in adhesion of platelets to collagen and hemostatic plug formation. The prolonged bleeding time in VON WILLEBRAND DISEASES is due to the deficiency of this factor.

A subtype of von Willebrand disease that results from a total or near total deficiency of VON WILLEBRAND FACTOR.

Group of hemorrhagic disorders in which the VON WILLEBRAND FACTOR is either quantitatively or qualitatively abnormal. They are usually inherited as an autosomal dominant trait though rare kindreds are autosomal recessive. Symptoms vary depending on severity and disease type but may include prolonged bleeding time, deficiency of factor VIII, and impaired platelet adhesion.

More From BioPortfolio on "Changes in Bleeding and Clotting During the Menstrual Cycle"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial