Thromboembolic DiseaseNCT00594763
Venous Thrombosis in Turner Syndrome
An observational study of Thromboembolic Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
In the literature, cases of thrombosis in the venous system have been described in girls and women with Turner syndrome. By screening a group of women with Turner syndrome, the researchers wish to find out if this condition is more frequent in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Thromboembolic Disease
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2006to Apr 2008
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with Turner syndrome
Who may be able to join
- Turner syndrome verified by karyotyping
- Aged 18 or above
Who cannot join
- Malignant disease
- Treatment with anticoagulants
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, Aarhus C, 8000
About this study
Official title: The Risk of Venous Thrombosis in Women With Turner Syndrome
In the literature, cases of thrombosis in the venous system have been described in girls and women with Turner syndrome. By screening a group of women with Turner syndrome, the researchers wish to find out if this condition is more frequent in this patient population.
Read the detailed description
In the literature cases of thrombosis in the venous system has been described in girls and women with Turner syndrome. By screening a group of women with Turner syndrome we wish to find out if this condition is more frequent in this patient population. Participants are examined with screening blood tests evaluating thromboembolic disturbances.
- Conditions
- Thromboembolic Disease
- Keywords
- Turner syndrome, Thromboembolic disease
- Medical subject headings
- Thromboembolism, Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TS | Women with Turner syndrome |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJun 2006
- Primary completionApr 2008 (estimated)
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jens Sandahl Christiansen, MD, dr.med, professor, Principal investigator, Medical Department of Endocrinology, Aarhus University Hospital, 8000 Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594763
- Sponsor's protocol ID
- 20050045
- Status last verified
- Jan 2008
- First submitted
- 7 Jan 2008
- Last updated
- 1 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Venous Thrombosis in Women With Turner Syndrome
- ClinicalTrials.gov ID
- NCT00594763
- Acronym / sponsor ID
- 20050045
- Conditions
- Thromboembolic Disease
- Keywords
- Turner syndrome, Thromboembolic disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Apr 2008 (estimated)
- First posted
- 16 Jan 2008 (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.
In the literature, cases of thrombosis in the venous system have been described in girls and women with Turner syndrome. By screening a group of women with Turner syndrome, the researchers wish to find out if this condition is more frequent in this patient population.
Detailed description
In the literature cases of thrombosis in the venous system has been described in girls and women with Turner syndrome. By screening a group of women with Turner syndrome we wish to find out if this condition is more frequent in this patient population. Participants are examined with screening blood tests evaluating thromboembolic disturbances.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TS | – | –Women with Turner syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Turner syndrome
Key inclusion criteria (2 listed)
- Turner syndrome verified by karyotyping
- Aged 18 or above
Key exclusion criteria (2 listed)
- Malignant disease
- Treatment with anticoagulants
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2008.
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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.
Jens Sandahl Christiansen, MD, dr.med, professor principal investigator
Medical Department of Endocrinology, Aarhus University Hospital, 8000 Aarhus, Denmark
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 Thromboembolic Disease, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Feb 2008. 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 Denmark. 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?
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.
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 1 Feb 2008.