Thromboembolism in Anorexia Nervosa (NCT05575466) | Clinical Trial Compass
CompletedNot Applicable
Thromboembolism in Anorexia Nervosa
Denmark, Sweden80 participantsStarted 2022-11-15
Plain-language summary
BACKGROUND: Sudden death due to thromboembolic (TE) events in patients with anorexia nervosa (AN) is well known. However, the incidence of TE events and the hemostatic balance in patients with AN are sparsely investigated. Also, associations between re-nutrition and the hemostatic balance have not been studied.
OBJECTIVE: To describe the incidence of TE events in patients with AN compared to the background population, to characterize the hemostatic balance in AN compared to normal-weight women, and to assess the associations between the hemostatic balance and nutritional status, insulin sensitivity and cortisol level in women with AN.
METHODS: The incidence of TE will be described using a Danish cohort of AN patients (n=10,049) with follow-up in national registries. A comprehensive battery of hemostatic biomarkers will be compared in a case-control study of 40 patients with AN and associations between hemostasis and nutritional status will be studied.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria, patients:
* Fulfilling Diagnostic and Statistical Manual V (DSM-5) criteria for AN
* Age 18 - 50 years
* Female sex
Exclusion Criteria, patients:
* Somatic comorbidity requiring systemic medications
* Previous thromboembolic event and/or known genetic predisposition
* Use of p.o. hormonal contraception
* Smoking
Inclusion Criteria, controls:
* BMI 18.5 - 25.0
* Age 18 - 50 years
* Female sex
Exclusion Criteria, controls:
* Somatic comorbidity requiring systemic medications
* Previous thromboembolic event and/or known genetic predisposition
* Use of p.o. hormonal contraception
* Smoking
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of thromboembolic events
Timeframe: Data on thromboembolic events are collected from health registries. Data is collected through study completion of the time frame in the registry, up to 26 years.