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

NCT04133220 | Unknown

• 1 other identifier: 190002
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia, Myeloid, Acute

Keywords

hemostasis

Outcome Measures

Primary Outcomes (28)

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-

  plasma concentration of ICAM-

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1

  plasma concentration of Syndecan-1

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag

  plasma concentration of vWF Ag

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by vWF activity

  vWF activity

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg

  plasma concentration of Fg

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA

  plasma concentration of t-PA

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA

  plasma concentration of u-PA

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin

  plasma concentration of e-Selectin

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L

  plasma concentration of sCD40L

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6

  plasma concentration of IL6

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT

  plasma concentration of AT

  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

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex

  plasma concentration of TAT complex

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex

  plasma concentration of plasmin-antiplasmin complex

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag

  plasma concentration of PAI-1 Ag

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity

  plasma concentration of PAI-1 activity

  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

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag

  plasma concentration of ADAMTS13 Ag

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity

  ADAMTS13 activity

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB

  plasma concentration of vWF:CB

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers

  plasma concentration of Fibrin monomers

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time

  Prothrombine Time

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT]

  Activated Partial Thromboplastin Time \[APTT\]

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX

  plasma concentration of Factor IX

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II

  plasma concentration of Factor II

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII

  plasma concentration of Factor VIII

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII

  plasma concentration of Factor XII

  12hours after chemotherapy initiation

• Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X

  plasma concentration of Factor X

  12hours after chemotherapy initiation

Secondary Outcomes (4)

• Cumulative incidence of serious bleeding events

  1 month

• Cumulative incidence of thrombotic events

  1 month

• Overall survival

  1 month

• ICU length of stay

  1 month

Study Arms (2)

Cases

Patients with acute myeloid leukemia, associated to hyper leukocytosis

Control

Patients with acute myeloid leukemia, without hyper leukocytosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute myleoid leukemia associated to hyper-leukocytosis

You may qualify if:

• De novo AML
• GB counts \> 50 G/L
• Eligible for intensive chemotherapy
• no previous AML treatment

You may not qualify if:

• secondary AML
• relapse of AML
• Acute promyelocytic leukemia
• Previous antiplatelet or anticoagulant treatment

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: October 21, 2019
• Study Start: October 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share