Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
NCT ID: NCT04133220
Last Updated: 2019-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2019-10-31
2022-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cases
Patients with acute myeloid leukemia, associated to hyper leukocytosis
No interventions assigned to this group
Control
Patients with acute myeloid leukemia, without hyper leukocytosis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* GB counts \> 50 G/L
* Eligible for intensive chemotherapy
* no previous AML treatment
Exclusion Criteria
* relapse of AML
* Acute promyelocytic leukemia
* Previous antiplatelet or anticoagulant treatment
18 Years
65 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Other Identifiers
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190002
Identifier Type: -
Identifier Source: org_study_id
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