Real-World Assessment of Venous Thromboembolic Risk in Hospitalized Patients With Acute Leukemia (The ReVeAL Study of the GIMEMA Working Party on Hemostasis and Thrombosis)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Number of patients with venous thromboembolism event during hospitalization
研究概览
简要总结
This is a observational study designed to identify risk factors for venous thromboembolism in patients with newly diagnosed acute leukemia at the time of first admission to a Hematology Ward.
Each patient will be observed for the duration of hospitalization.
详细描述
This is a prospective, observational cohort study designed to identify risk factors for venous thromboembolism (VTE) in patients with newly diagnosed acute leukemia (AL) at the time of first admission to a Hematology Ward. The study will be conducted within the GIMEMA network of Italian Hematology Centers.
The observation period for each patient will correspond to the duration of hospitalization, starting from the day of admission to the Hematology Ward, irrespective of whether antithrombotic therapy is prescribed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or greater than 18 years of age
- •New diagnosis of Acute Leukemia (APL, other AML, ALL) according to the current diagnostic criteria of the ELN 2022 for myeloid lineage (AML/APL) and ELN 2024 for lymphoid lineage (ALL)
- •Hospitalization in a Hematology Ward lasting at least 2 days
- •Signed informed consent
排除标准
- •Ongoing therapeutic-dose anticoagulant treatment at the time of admission (i.e., dosage exceeding standard thromboprophylactic regimens)
- •Diagnosis of venous thromboembolism (VTE) or major bleeding (MB) occurring within 48 hours of hospital admission
结局指标
主要结局
Number of patients with venous thromboembolism event during hospitalization
时间窗: through study completion, an average of 2 years
Cumulative incidence of the first venous thromboembolism event from hospital admission to discharge or death
次要结局
未报告次要终点