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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study will include patients with newly diagnosed acute leukemia at the time of first admission to a Hematology Ward.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Number of patients with venous thromboembolism event during hospitalization

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

Time frame
through study completion, an average of 2 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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