An observational study in Leukemia, Myeloid, Acute, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-21.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with acute myleoid leukemia associated to hyper-leukocytosis
Exclusion Criteria:
Patients with acute myeloid leukemia, associated to hyper leukocytosis
Patients with acute myeloid leukemia, without hyper leukocytosis
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-
plasma concentration of ICAM-
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1
plasma concentration of Syndecan-1
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag
plasma concentration of vWF Ag
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by vWF activity
vWF activity
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg
plasma concentration of Fg
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA
plasma concentration of t-PA
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA
plasma concentration of u-PA
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin
plasma concentration of e-Selectin
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L
plasma concentration of sCD40L
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6
plasma concentration of IL6
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT
plasma concentration of AT
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2
plasma concentration of Fragments thrombin 1+2
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex
plasma concentration of TAT complex
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex
plasma concentration of plasmin-antiplasmin complex
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag
plasma concentration of PAI-1 Ag
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity
plasma concentration of PAI-1 activity
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA-PAI-1 complex
plasma concentration of t-PA-PAI-1 complex
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag
plasma concentration of ADAMTS13 Ag
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity
ADAMTS13 activity
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB
plasma concentration of vWF:CB
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers
plasma concentration of Fibrin monomers
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time
Prothrombine Time
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT]
Activated Partial Thromboplastin Time \[APTT\]
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX
plasma concentration of Factor IX
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II
plasma concentration of Factor II
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII
plasma concentration of Factor VIII
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII
plasma concentration of Factor XII
Time frame: 12hours after chemotherapy initiation
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X
plasma concentration of Factor X
Time frame: 12hours after chemotherapy initiation
Cumulative incidence of serious bleeding events
Time from inclusion to first serious bleeding event
Time frame: 1 month
Cumulative incidence of thrombotic events
Time from inclusion to first thrombotic event
Time frame: 1 month
Overall survival
Time from inclusion to death of any cause
Time frame: 1 month
ICU length of stay
duration of stay in ICU within the first month
Time frame: 1 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris