Predicting and Preventing Poor Outcomes of Venous Thromboembolism in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Symptomatic recurrent venous thromboembolism
研究概览
简要总结
'The TOP Study' is a prospective cohort study whose main objective is to develop better prognostic biomarkers and identify children at risk of adverse thrombotic outcomes very early in the course after an initial venous thromboembolic events (VTE). The study will compare biomarkers in children that develop poor VTE outcomes (such as recurrence, postthrombotic syndrome and post PE impairment ) after an initial VTE with those that do not develop such outcomes.
详细描述
All newly diagnosed patients with a first radiologically confirmed thrombotic event (any site) diagnosed at Children's Medical Center, Dallas will be followed prospectively with global coagulation assessment over a 24-month period, and monitored for development of carefully defined adverse VTE outcomes in a blinded manner. Biomarker assessment will include global coagulation assays (thrombin generation assay and modified thromboelastography to study fibrinolysis) at 3, 6, 12, 18 and 24 months post VTE diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls age birth (0 years) to equal to or less than 21 years
- •A radiologically confirmed first venous thromboembolism episode (both extremity and non-extremity) who have completed anticoagulation therapy as per the 9th edition of the ACCP guidelines
排除标准
- •Known malignancy
- •Pregnancy or immediate post-partum period (12 weeks after delivery)
- •Sickle cell disease
- •Known bleeding disorder
结局指标
主要结局
Symptomatic recurrent venous thromboembolism
时间窗: within 24 months after diagnosis of VTE
Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria
Post-pulmonary embolism (PE) impairment
时间窗: within 24 months after diagnosis of VTE
Post-PE impairment, defined as deterioration (compared to discharge or previous follow-up visit), or persistence, in a) echocardiographic parameters of right ventricular (RV) dysfunction (defined by abnormal RV basal diameter or abnormal right atrial end systolic area or abnormal tricuspid annular plane systolic excursion or presence of pericardial effusion) and/or pulmonary hypertension (defined by abnormal estimated right atrial pressure or elevated systolic tricuspid regurgitant velocity), and clinical, functional parameters of RV failure (new appearance of symptoms of heart failure or abnormal six-minute walking distance or elevated brain natriuretic peptide (BNP) plasma levels or abnormal peak O2 uptake on cardiopulmonary exercise testing)
Postthrombotic syndrome (PTS)
时间窗: within 24 months after diagnosis of VTE
PTS as assessed by the validated Manco-Johnson and the modified Villata PTS instruments determined a priori and confirmed by an endpoint adjudicating committee
次要结局
- Change in quality of life(Within 24 months after diagnosis of VTE)
- Post-thrombotic sequelae(Within 24 months after diagnosis of VTE)
研究者
Ayesha Zia
Associate Professor of Pediatrics
University of Texas Southwestern Medical Center