Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia (HEAL)
2019年10月18日 更新者：Assistance Publique - Hôpitaux de Paris
Characterization of Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
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.
研究概览
地位
未知
条件
研究类型
观察性的
注册 (预期的)
60
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with acute myleoid leukemia associated to hyper-leukocytosis
描述
Inclusion Criteria:
- De novo AML
- GB counts > 50 G/L
- Eligible for intensive chemotherapy
- no previous AML treatment
Exclusion Criteria:
- secondary AML
- relapse of AML
- Acute promyelocytic leukemia
- Previous antiplatelet or anticoagulant treatment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
|---|
|
Cases
Patients with acute myeloid leukemia, associated to hyper leukocytosis
|
|
Control
Patients with acute myeloid leukemia, without hyper leukocytosis
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-
大体时间：12hours after chemotherapy initiation
|
plasma concentration of ICAM-
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1
大体时间：12hours after chemotherapy initiation
|
plasma concentration of Syndecan-1
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag
大体时间：12hours after chemotherapy initiation
|
plasma concentration of vWF Ag
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by vWF activity
大体时间：12hours after chemotherapy initiation
|
vWF activity
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg
大体时间：12hours after chemotherapy initiation
|
plasma concentration of Fg
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA
大体时间：12hours after chemotherapy initiation
|
plasma concentration of t-PA
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA
大体时间：12hours after chemotherapy initiation
|
plasma concentration of u-PA
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin
大体时间：12hours after chemotherapy initiation
|
plasma concentration of e-Selectin
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L
大体时间：12hours after chemotherapy initiation
|
plasma concentration of sCD40L
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6
大体时间：12hours after chemotherapy initiation
|
plasma concentration of IL6
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT
大体时间：12hours after chemotherapy initiation
|
plasma concentration of AT
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2
大体时间：12hours after chemotherapy initiation
|
plasma concentration of Fragments thrombin 1+2
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex
大体时间：12hours after chemotherapy initiation
|
plasma concentration of TAT complex
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex
大体时间：12hours after chemotherapy initiation
|
plasma concentration of plasmin-antiplasmin complex
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag
大体时间：12hours after chemotherapy initiation
|
plasma concentration of PAI-1 Ag
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity
大体时间：12hours after chemotherapy initiation
|
plasma concentration of PAI-1 activity
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA-PAI-1 complex
大体时间：12hours after chemotherapy initiation
|
plasma concentration of t-PA-PAI-1 complex
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag
大体时间：12hours after chemotherapy initiation
|
plasma concentration of ADAMTS13 Ag
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity
大体时间：12hours after chemotherapy initiation
|
ADAMTS13 activity
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB
大体时间：12hours after chemotherapy initiation
|
plasma concentration of vWF:CB
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers
大体时间：12hours after chemotherapy initiation
|
plasma concentration of Fibrin monomers
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time
大体时间：12hours after chemotherapy initiation
|
Prothrombine Time
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT]
大体时间：12hours after chemotherapy initiation
|
Activated Partial Thromboplastin Time [APTT]
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX
大体时间：12hours after chemotherapy initiation
|
plasma concentration of Factor IX
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II
大体时间：12hours after chemotherapy initiation
|
plasma concentration of Factor II
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII
大体时间：12hours after chemotherapy initiation
|
plasma concentration of Factor VIII
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII
大体时间：12hours after chemotherapy initiation
|
plasma concentration of Factor XII
|
12hours after chemotherapy initiation
|
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X
大体时间：12hours after chemotherapy initiation
|
plasma concentration of Factor X
|
12hours after chemotherapy initiation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative incidence of serious bleeding events
大体时间：1 month
|
Time from inclusion to first serious bleeding event
|
1 month
|
|
Cumulative incidence of thrombotic events
大体时间：1 month
|
Time from inclusion to first thrombotic event
|
1 month
|
|
Overall survival
大体时间：1 month
|
Time from inclusion to death of any cause
|
1 month
|
|
ICU length of stay
大体时间：1 month
|
duration of stay in ICU within the first month
|
1 month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年10月1日
初级完成 (预期的)
2022年2月1日
研究完成 (预期的)
2022年7月1日
研究注册日期
首次提交
2019年7月1日
首先提交符合 QC 标准的
2019年10月18日
首次发布 (实际的)
2019年10月21日
研究记录更新
最后更新发布 (实际的)
2019年10月21日
上次提交的符合 QC 标准的更新
2019年10月18日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
白血病，骨髓，急性的临床试验
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Shenzhen Second People's Hospital招聘中白血病 | 骨髓的 | 慢性的 | BCR-ABL (Breakpoint Cluster Region-abelson Murine Leukemia) | 积极的中国