Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
- Conditions
- Leukemia, Myeloid, Acute
- Registration Number
- NCT04133220
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- De novo AML
- GB counts > 50 G/L
- Eligible for intensive chemotherapy
- no previous AML treatment
- secondary AML
- relapse of AML
- Acute promyelocytic leukemia
- Previous antiplatelet or anticoagulant treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag 12hours after chemotherapy initiation plasma concentration of PAI-1 Ag
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X 12hours after chemotherapy initiation plasma concentration of Factor X
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1 12hours after chemotherapy initiation plasma concentration of Syndecan-1
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2 12hours after chemotherapy initiation plasma concentration of Fragments thrombin 1+2
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB 12hours after chemotherapy initiation plasma concentration of vWF:CB
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag 12hours after chemotherapy initiation plasma concentration of vWF Ag
Hemostasis / platelet and endothelial dysfunction assessed by vWF activity 12hours after chemotherapy initiation vWF activity
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA 12hours after chemotherapy initiation plasma concentration of u-PA
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L 12hours after chemotherapy initiation plasma concentration of sCD40L
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6 12hours after chemotherapy initiation plasma concentration of IL6
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity 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 12hours after chemotherapy initiation plasma concentration of t-PA-PAI-1 complex
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers 12hours after chemotherapy initiation plasma concentration of Fibrin monomers
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag 12hours after chemotherapy initiation plasma concentration of ADAMTS13 Ag
Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity 12hours after chemotherapy initiation ADAMTS13 activity
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II 12hours after chemotherapy initiation plasma concentration of Factor II
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM- 12hours after chemotherapy initiation plasma concentration of ICAM-
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg 12hours after chemotherapy initiation plasma concentration of Fg
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA 12hours after chemotherapy initiation plasma concentration of t-PA
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin 12hours after chemotherapy initiation plasma concentration of e-Selectin
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT 12hours after chemotherapy initiation plasma concentration of AT
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex 12hours after chemotherapy initiation plasma concentration of TAT complex
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex 12hours after chemotherapy initiation plasma concentration of plasmin-antiplasmin complex
Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time 12hours after chemotherapy initiation Prothrombine Time
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII 12hours after chemotherapy initiation plasma concentration of Factor VIII
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII 12hours after chemotherapy initiation plasma concentration of Factor XII
Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT] 12hours after chemotherapy initiation Activated Partial Thromboplastin Time \[APTT\]
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX 12hours after chemotherapy initiation plasma concentration of Factor IX
- Secondary Outcome Measures
Name Time Method Overall survival 1 month Time from inclusion to death of any cause
Cumulative incidence of serious bleeding events 1 month Time from inclusion to first serious bleeding event
ICU length of stay 1 month duration of stay in ICU within the first month
Cumulative incidence of thrombotic events 1 month Time from inclusion to first thrombotic event