Clinical trial · Observational
Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
Characterization of Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- Patients with acute myeloid leukemia, associated to hyper leukocytosis
- label
- Control
- description
- Patients with acute myeloid leukemia, without hyper leukocytosis
Primary outcomes (28)
- measure
- Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-
- timeFrame
- 12hours after chemotherapy initiation
- description
- plasma concentration of ICAM-
- measure
- Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1
- timeFrame
- 12hours after chemotherapy initiation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available