Real World Assessment of Venous Thromboembolic Risk in Hospitalized Patients With Acute Leukemia

This is a observational study designed to identify risk factors for venous thromboembolism in patients with newly diagnosed acute leukemia at the time of first admission to a Hematology Ward.

Each patient will be observed for the duration of hospitalization.

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Key information

Conditions

Acute Leukemia Newly Diagnosed Acute Leukemia Thromboprophylaxis Thromboprophylaxis in Acute Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a prospective, observational cohort study designed to identify risk factors for venous thromboembolism (VTE) in patients with newly diagnosed acute leukemia (AL) at the time of first admission to a Hematology Ward. The study will be conducted within the GIMEMA network of Italian Hematology Centers.

The observation period for each patient will correspond to the duration of hospitalization, starting from the day of admission to the Hematology Ward, irrespective of whether antithrombotic therapy is prescribed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age equal to or greater than 18 years of age
New diagnosis of Acute Leukemia (APL, other AML, ALL) according to the current diagnostic criteria of the ELN 2022 for myeloid lineage (AML/APL) and ELN 2024 for lymphoid lineage (ALL)
Hospitalization in a Hematology Ward lasting at least 2 days
Signed informed consent

Exclusion criteria

Ongoing therapeutic-dose anticoagulant treatment at the time of admission (i.e., dosage exceeding standard thromboprophylactic regimens)
Diagnosis of venous thromboembolism (VTE) or major bleeding (MB) occurring within 48 hours of hospital admission

Treatment and study plan

Primary outcomes

Number of patients with venous thromboembolism event during hospitalization

Time frame: through study completion, an average of 2 years

Cumulative incidence of the first venous thromboembolism event from hospital admission to discharge or death

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Crea

CONTACT

[email protected]

+39 0670390514

Paola Fazi

CONTACT

[email protected]

+39 0670390522

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

Real-World Assessment of Venous Thromboembolic Risk in Hospitalized Patients With Acute Leukemia (The ReVeAL Study of the GIMEMA Working Party on Hemostasis and Thrombosis)

Acronym: ReVeAL

Important dates

Study start: 2027
Primary completion: 2029
Study completion: 2029
First posted: Sep 21, 2026
Registry last updated: Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not yet recruiting