Von Willebrand DiseaseNCT00178542
Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
An observational study of Von Willebrand Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Von Willebrand Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Females with a diagnosis of von Willebrand Disease
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Changes in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
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.
Read the 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.
- Conditions
- Von Willebrand Disease
- Keywords
- von Willebrand Disease, Healthy Women and Women with von Willebrand Disease
- Medical subject headings
- von Willebrand Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous Thrombin Potential
Comparison of 4 values collected during 4 phases of through the menstrual cycle
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The ZLB Behring Foundation
- Responsible party
- Principal investigator, Deborah Brown, The University of Texas Health Science Center, Houston
- Investigators
- Deborah Brown, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178542
- Sponsor's protocol ID
- TG and TEG
- Status last verified
- May 2013
- First submitted
- 12 Sep 2005
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT00178542
- Acronym / sponsor ID
- TG and TEG
- Conditions
- Von Willebrand Disease
- Keywords
- von Willebrand Disease, Healthy Women and Women with von Willebrand Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The ZLB Behring Foundation
- Study start
- Sep 2005
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females with a diagnosis of von Willebrand Disease
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endogenous Thrombin Potential
Time frame: 4 weeks
Comparison of 4 values collected during 4 phases of through the menstrual cycle
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
Related trials for Von Willebrand Disease
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Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation
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RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Brown, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Willebrand Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endogenous Thrombin Potential (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.