Characterization of Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag
研究概览
简要总结
Hyper-leukocytosis > 50.109/L is observed in 15% of acute myeloid leukemia (AML).
Level of hyper-leukocytosis is linearly associated with the incidence of life threatening complications that lead to the early death in 25% of these patients.
The HEAL project is a prospective, uni-centric, observational study that plans to include a cohort of 50 patients presenting de novo AML with hyper-leukocytosis (HL) (> 50.109/L) and 10 controls. The aim of the study is to describe the relative proportion of various hemostasis components disturbances, endothelium alterations, platelet dysfunction and to calculate cumulative incidence of hemorrhagic and thrombotic complications as well as overall survival of patients presenting with HL AML.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo AML
- •GB counts > 50 G/L
- •Eligible for intensive chemotherapy
- •no previous AML treatment
排除标准
- •secondary AML
- •relapse of AML
- •Acute promyelocytic leukemia
- •Previous antiplatelet or anticoagulant treatment
结局指标
主要结局
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag
时间窗: 12hours after chemotherapy initiation
plasma concentration of PAI-1 Ag
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X
时间窗: 12hours after chemotherapy initiation
plasma concentration of Factor X
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA
时间窗: 12hours after chemotherapy initiation
plasma concentration of t-PA
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1
时间窗: 12hours after chemotherapy initiation
plasma concentration of Syndecan-1
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2
时间窗: 12hours after chemotherapy initiation
plasma concentration of Fragments thrombin 1+2
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB
时间窗: 12hours after chemotherapy initiation
plasma concentration of vWF:CB
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag
时间窗: 12hours after chemotherapy initiation
plasma concentration of vWF Ag
Hemostasis / platelet and endothelial dysfunction assessed by vWF activity
时间窗: 12hours after chemotherapy initiation
vWF activity
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA
时间窗: 12hours after chemotherapy initiation
plasma concentration of u-PA
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L
时间窗: 12hours after chemotherapy initiation
plasma concentration of sCD40L
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6
时间窗: 12hours after chemotherapy initiation
plasma concentration of IL6
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity
时间窗: 12hours after chemotherapy initiation
plasma concentration of PAI-1 activity
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA-PAI-1 complex
时间窗: 12hours after chemotherapy initiation
plasma concentration of t-PA-PAI-1 complex
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers
时间窗: 12hours after chemotherapy initiation
plasma concentration of Fibrin monomers
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag
时间窗: 12hours after chemotherapy initiation
plasma concentration of ADAMTS13 Ag
Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity
时间窗: 12hours after chemotherapy initiation
ADAMTS13 activity
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II
时间窗: 12hours after chemotherapy initiation
plasma concentration of Factor II
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-
时间窗: 12hours after chemotherapy initiation
plasma concentration of ICAM-
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg
时间窗: 12hours after chemotherapy initiation
plasma concentration of Fg
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin
时间窗: 12hours after chemotherapy initiation
plasma concentration of e-Selectin
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT
时间窗: 12hours after chemotherapy initiation
plasma concentration of AT
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex
时间窗: 12hours after chemotherapy initiation
plasma concentration of TAT complex
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex
时间窗: 12hours after chemotherapy initiation
plasma concentration of plasmin-antiplasmin complex
Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time
时间窗: 12hours after chemotherapy initiation
Prothrombine Time
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII
时间窗: 12hours after chemotherapy initiation
plasma concentration of Factor VIII
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII
时间窗: 12hours after chemotherapy initiation
plasma concentration of Factor XII
Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT]
时间窗: 12hours after chemotherapy initiation
Activated Partial Thromboplastin Time \[APTT\]
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX
时间窗: 12hours after chemotherapy initiation
plasma concentration of Factor IX
次要结局
- Overall survival(1 month)
- Cumulative incidence of serious bleeding events(1 month)
- ICU length of stay(1 month)
- Cumulative incidence of thrombotic events(1 month)