Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia

Leukemia, Myeloid, Acute Clinical Trial

— HEAL  

Official title:

Characterization of Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04133220
• Other study ID #: 190002
• Status: Not yet recruiting
• Start date: October 2019
• Est. completion date: July 2022

Study information

• Verified date: June 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-	plasma concentration of ICAM-	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1	plasma concentration of Syndecan-1	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag	plasma concentration of vWF Ag	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by vWF activity	vWF activity	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg	plasma concentration of Fg	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA	plasma concentration of t-PA	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA	plasma concentration of u-PA	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin	plasma concentration of e-Selectin	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L	plasma concentration of sCD40L	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6	plasma concentration of IL6	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT	plasma concentration of AT	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2	plasma concentration of Fragments thrombin 1+2	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex	plasma concentration of TAT complex	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex	plasma concentration of plasmin-antiplasmin complex	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag	plasma concentration of PAI-1 Ag	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity	plasma concentration of PAI-1 activity	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA-PAI-1 complex	plasma concentration of t-PA-PAI-1 complex	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag	plasma concentration of ADAMTS13 Ag	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity	ADAMTS13 activity	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB	plasma concentration of vWF:CB	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers	plasma concentration of Fibrin monomers	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time	Prothrombine Time	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT]	Activated Partial Thromboplastin Time [APTT]	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX	plasma concentration of Factor IX	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II	plasma concentration of Factor II	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII	plasma concentration of Factor VIII	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII	plasma concentration of Factor XII	12hours after chemotherapy initiation
Primary	Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X	plasma concentration of Factor X	12hours after chemotherapy initiation
Secondary	Cumulative incidence of serious bleeding events	Time from inclusion to first serious bleeding event	1 month
Secondary	Cumulative incidence of thrombotic events	Time from inclusion to first thrombotic event	1 month
Secondary	Overall survival	Time from inclusion to death of any cause	1 month
Secondary	ICU length of stay	duration of stay in ICU within the first month	1 month