ClinicalTrials.gg
Not yet recruitingNCT07831668ReVeALUpdated Sep 21, 2026

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

An observational study in Acute Leukemia, Newly Diagnosed Acute Leukemia and Thromboprophylaxis, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Acute Leukemia
  • Newly Diagnosed Acute Leukemia
  • Thromboprophylaxis
  • Thromboprophylaxis in Acute Leukemia
03

In context

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 135 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age equal to or greater than 18 years of age
  2. 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)
  3. Hospitalization in a Hematology Ward lasting at least 2 days
  4. Signed

Exclusion criteria

Exclusion Criteria:

  1. Ongoing therapeutic-dose anticoagulant treatment at the time of admission (i.e., dosage exceeding standard thromboprophylactic regimens)
  2. Diagnosis of venous thromboembolism (VTE) or major bleeding (MB) occurring within 48 hours of hospital admission
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07831668
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Sep 21, 2026

Study contacts

Paola Fazi
Contact
gimema@gimema.it
+39 0670390522
Enrico Crea
Contact
e.crea@gimema.it
+39 0670390514
Marco Marietta, MD
principal investigator · Hematology Unit AOU Modena - Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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