Leukemia, Myeloid, Acute
Conditions
Keywords
hemostasis
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 assessed by plasma concentration of Factor IX | 12hours after chemotherapy initiation | plasma concentration of Factor IX |
| 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 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 Prothrombine Time | 12hours after chemotherapy initiation | Prothrombine Time |
| 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 ICAM- | 12hours after chemotherapy initiation | plasma concentration of ICAM- |
| 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 assessed by plasma concentration of Fibrin monomers | 12hours after chemotherapy initiation | plasma concentration of Fibrin monomers |
| 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 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 Fg | 12hours after chemotherapy initiation | plasma concentration of Fg |
| 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 | 12hours after chemotherapy initiation | plasma concentration of t-PA |
| 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 e-Selectin | 12hours after chemotherapy initiation | plasma concentration of e-Selectin |
| 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 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 AT | 12hours after chemotherapy initiation | plasma concentration of AT |
| 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 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 plasma concentration of PAI-1 Ag | 12hours after chemotherapy initiation | plasma concentration of PAI-1 Ag |
| Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT] | 12hours after chemotherapy initiation | Activated Partial Thromboplastin Time \[APTT\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of thrombotic events | 1 month | Time from inclusion to first thrombotic event |
| Overall survival | 1 month | Time from inclusion to death of any cause |
| ICU length of stay | 1 month | duration of stay in ICU within the first month |
| Cumulative incidence of serious bleeding events | 1 month | Time from inclusion to first serious bleeding event |
Outcome results
None listed