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CompletedNCT02407717Updated Aug 8, 2019

Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer

An observational study in Hemorrhage and Vein Thrombosis, sponsored by G. d'Annunzio University. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by G. d'Annunzio University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
330
Ages
18 Years and older
Sex
All
01

Study summary

Patients with cancer hospitalized for an acute medical illness have an increased risk of venous thromboembolic events. Although international guidelines suggest the use of thromboprophylaxis in these patients, the recommendations are based on studies which included a percentage of patients with cancer without primarily focusing on this high risk group.

Since patients with cancer present an increased risk of bleeding complications it is critical to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a limited use of thromboprophylaxis in these patients.

The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in medical cancer patients hospitalized for an acute medical disease.

Design: observational, prospective study Primary end-point: incidence of major and clinically relevant non major bleeding during hospitalization Secondary endpoints: frequency of use, doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic events up to three months after discharge

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Conditions studied

03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 330 is above the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

G. d'Annunzio University is the lead sponsor of 62 studies on the registry; 21 are open to participants now.

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

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Who can participate

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

Study population

Patients with cancer hospitalized for an acute medical illness

Inclusion criteria

  • all patients with cancer hospitalized for an acute medical illness

Exclusion criteria

Exclusion Criteria:

  • current use of oral or parenteral anticoagulant treatment
  • no informed consent to participate
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
330 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Major bleeding and clinically relevant non major bleeding

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary outcomes

  1. Venous thromboembolism

    Time frame: Participants will be followed up to 3 months after discharge, an expected average of 13 weeks

  2. Minor bleeding

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

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Study locations

1 site
  • Universita degli Studi G. d'Annunzio Chieti e Pescara
    Chieti, 66100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02407717
Lead sponsor
G. d'Annunzio University
Responsible party
Marcello Di Nisio (Principal Investigator, G. d'Annunzio University) — Principal investigator
First posted
Apr 3, 2015
Start date
Apr 2015
Primary completion
Aug 2017
Completion
Jul 2018
Last update
Aug 8, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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