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Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia (HEAL)
Characterization of Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Verwacht)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
---|
Cases
Patients with acute myeloid leukemia, associated to hyper leukocytosis
|
Control
Patients with acute myeloid leukemia, without hyper leukocytosis
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of ICAM-
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of Syndecan-1
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of vWF Ag
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by vWF activity
Tijdsspanne: 12hours after chemotherapy initiation
|
vWF activity
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of Fg
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of t-PA
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of u-PA
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of e-Selectin
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of sCD40L
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of IL6
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of AT
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of Fragments thrombin 1+2
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of TAT complex
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of plasmin-antiplasmin complex
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of PAI-1 Ag
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity
Tijdsspanne: 12hours after chemotherapy initiation
|
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
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of t-PA-PAI-1 complex
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of ADAMTS13 Ag
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity
Tijdsspanne: 12hours after chemotherapy initiation
|
ADAMTS13 activity
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of vWF:CB
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of Fibrin monomers
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time
Tijdsspanne: 12hours after chemotherapy initiation
|
Prothrombine Time
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT]
Tijdsspanne: 12hours after chemotherapy initiation
|
Activated Partial Thromboplastin Time [APTT]
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of Factor IX
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of Factor II
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of Factor VIII
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of Factor XII
|
12hours after chemotherapy initiation
|
Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X
Tijdsspanne: 12hours after chemotherapy initiation
|
plasma concentration of Factor X
|
12hours after chemotherapy initiation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Cumulative incidence of serious bleeding events
Tijdsspanne: 1 month
|
Time from inclusion to first serious bleeding event
|
1 month
|
Cumulative incidence of thrombotic events
Tijdsspanne: 1 month
|
Time from inclusion to first thrombotic event
|
1 month
|
Overall survival
Tijdsspanne: 1 month
|
Time from inclusion to death of any cause
|
1 month
|
ICU length of stay
Tijdsspanne: 1 month
|
duration of stay in ICU within the first month
|
1 month
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 190002
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