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Leukemia, Myeloid, AcuteHEALNCT04133220

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

An observational study of Leukemia, Myeloid, Acute, run by Assistance Publique - Hôpitaux de Paris.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Leukemia, Myeloid, Acute
How many people
60 participants
Where
No sites listed yet
Study dates
Oct 2019to Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with acute myleoid leukemia associated to hyper-leukocytosis

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Keywords
hemostasis
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04133220
Study groupRoleWhat they receive
CasesPatients with acute myeloid leukemia, associated to hyper leukocytosis
ControlPatients with acute myeloid leukemia, without hyper leukocytosis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    plasma concentration of ICAM-

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of Syndecan-1

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of vWF Ag

    Measured: 12hours after chemotherapy initiation

  4. Hemostasis / platelet and endothelial dysfunction assessed by vWF activity

    vWF activity

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of Fg

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of t-PA

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of u-PA

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of e-Selectin

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of sCD40L

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of IL6

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of AT

    Measured: 12hours after chemotherapy initiation

  12. Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2

    plasma concentration of Fragments thrombin 1+2

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of TAT complex

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of plasmin-antiplasmin complex

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of PAI-1 Ag

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of PAI-1 activity

    Measured: 12hours after chemotherapy initiation

  17. Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA-PAI-1 complex

    plasma concentration of t-PA-PAI-1 complex

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of ADAMTS13 Ag

    Measured: 12hours after chemotherapy initiation

  19. Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity

    ADAMTS13 activity

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of vWF:CB

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of Fibrin monomers

    Measured: 12hours after chemotherapy initiation

  22. Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time

    Prothrombine Time

    Measured: 12hours after chemotherapy initiation

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

    Activated Partial Thromboplastin Time [APTT]

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of Factor IX

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of Factor II

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of Factor VIII

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of Factor XII

    Measured: 12hours after chemotherapy initiation

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

    plasma concentration of Factor X

    Measured: 12hours after chemotherapy initiation

Secondary outcomes (4)

  1. Cumulative incidence of serious bleeding events

    Time from inclusion to first serious bleeding event

    Measured: 1 month

  2. Cumulative incidence of thrombotic events

    Time from inclusion to first thrombotic event

    Measured: 1 month

  3. Overall survival

    Time from inclusion to death of any cause

    Measured: 1 month

  4. ICU length of stay

    duration of stay in ICU within the first month

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study startOct 2019 (estimated)
  3. Primary completionFeb 2022 (estimated)
  4. Study completionJul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133220
Sponsor's protocol ID
190002
Acronym
HEAL
Status last verified
Jun 2019
First submitted
1 Jul 2019
Last updated
21 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, Myeloid, Acute, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM- (time frame: 12hours after chemotherapy initiation). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.

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