Clinical trial NCT04133220: Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
Official title: Characterization of Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia, Myeloid, Acute
Keywords: hemostasis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute myleoid leukemia associated to hyper-leukocytosis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by vWF activity
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA-PAI-1 complex
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT]
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII
timeFrame: 12hours after chemotherapy initiation
measure: Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X
timeFrame: 12hours after chemotherapy initiation
Secondary outcomes:
measure: Cumulative incidence of serious bleeding events
timeFrame: 1 month
measure: Cumulative incidence of thrombotic events
timeFrame: 1 month
measure: Overall survival
timeFrame: 1 month
measure: ICU length of stay
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References: