Thromboembolism in Anorexia Nervosa: a Registry-based Study of a National Cohort and a Case-control Study of the Hemostatic Balance and Its Association with Nutritional Status, Insulin and Cortisol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Incidence of thromboembolic events
研究概览
简要总结
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.
详细描述
BACKGROUND
Anorexia nervosa (AN) is a complex psychiatric disorder with concomitant medical complications to malnutrition and starvation and it is associated with the highest mortality of the mental illnesses.
It is estimated that one-third of all deaths in patients with AN are due to cardiac causes, mainly sudden death, and alterations in cardiac electrical activity, structure and hemodynamics have been suggested as mortality causes. Thrombotic disorders such as myocardial infarction, stroke, and pulmonary embolism may also result in sudden cardiac death, and the investigators have previously reported venous thromboembolism in four patients with AN
Whether a disturbed hemostatic balance is associated with re-nutrition, insulin sensitivity and cortisol in AN is unknown. The guidelines of thromboprophylaxis treatment may not be appropriate in this patient group due to metabolic and hemostatic disturbances and increased thrombotic risk of reasons related to refeeding syndrome not listed in current guidelines. To optimize guidelines for AN patients, new evidence is highly warranted
AIMS
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of thromboembolic events
时间窗: 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.
Arterial and venous thrombosis. Non-fatal outcomes of a thromboembolic event will be validated by the use of anticoagulants in the period immediately after the outcome defining event.
次要结局
未报告次要终点
研究者
Jeanie Meincke Egedal, MD
Medical Doctor
Odense University Hospital