CClinicalTrials.gg
Status unknownNCT03157843AURELIOUpdated May 17, 2017

Rate of Venous Thrombosis in Acutely Ill Patients Hospitalized in Internal Medicine Wards

An observational study in Venous Thromboembolism and Deep Venous Thrombosis, sponsored by University of Roma La Sapienza. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by University of Roma La Sapienza · Observational

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years to 90 Years
Sex
All
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Study summary

After reports from observational studies suggesting an association between acutely ill medical patients and venous thromboembolism (VTE), interventional trials with anticoagulants drugs have demonstrated a significant reduction of VTE during and immediately after hospitalisation. Although several guidelines suggest the clinical relevance of reducing this outcome, there is a low tendency to use anticoagulants in patients hospitalised for acute medical illness. This observational multicentre study wants to evaluate the incidence of venous thrombo-embolism in acutely ill patients hospitalized in internal medicine wards.

Read the detailed description

Epidemiological studies have provided evidence of a high rate of thromboembolism in patients hospitalised in medical wards. Based on this, several clinical trials with anticoagulants including low-molecular-weight heparin (LMWH) and fondaparinux have been performed in patients hospitalised for acute medical illness to prevent thromboembolism. Interventional trials consistently showed that prophylaxis with anticoagulants reduces the risk of composite endpoints of deep venous thrombosis (DVT), pulmonary embolism (PE) and DVT-related death. These results prompted recommendation to the use anticoagulant prophylaxis in patients hospitalised for acute medical illness, but, despite this, there is a widespread underuse of anticoagulant prophylaxis in the medical wards of hospitals.

This observational multicentre study wants to evaluate the incidence of venous thrombo-embolism in acutely ill patients hospitalized in internal medicine wards.

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Conditions studied

  • Venous Thromboembolism
  • Deep Venous Thrombosis
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In context

Thrombosis

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

This study's planned enrollment of 1,000 is above the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 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 to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients hospitalised for acute medical illness

Inclusion criteria

  • pneumonia
  • heart failure
  • Chronic Obstructive Pulmonary Disease
  • Kidney failure
  • syncope
  • atrial fibrillation
  • Urinary Tract Infection
  • Anemia
  • arthritis
  • Diabetic Ketoacidosis
  • unstable angina
  • asthma
  • cirrhosis

Exclusion criteria

Exclusion Criteria:

  • treatment with vitamin k inhibitors
  • surgical interventions
  • deep venous thrombosis
  • pulmonary embolism
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Medical Patients

    Medical patients who received, at admission and during all the length of recovery, antithrombotic drugs (low-molecular-weight heparin at prophylactic dosage ).

    Drug: low-molecular-weight heparin

  • Control Group

    Medical patients not treated with antithrombotic drugs during the recovery. Subjects age, sex and comorbidities matched.

Interventions

  • Druglow-molecular-weight heparin
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What researchers measure

Primary outcomes

  1. Venous thrombo-embolism

    Evaluation of deep venous thrombosis by compression ultrasonography (CUS)

    Time frame: Baseline, up to 4 weeks

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2017, 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
NCT03157843
Lead sponsor
University of Roma La Sapienza
Responsible party
Francesco Violi (Principal Investigator, Clinical Professor, MD, University of Roma La Sapienza) — Principal investigator
First posted
May 17, 2017
Start date
Feb 2015
Primary completion
Dec 2017 (estimated)
Completion
Jan 2018 (estimated)
Last update
May 17, 2017

Study contacts

Francesco Violi, MD
Contact
francesco.violi@uniroma1.it
064461933 ext. +39
Lorenzo Loffredo, MD
Contact
lorenzo.loffredo@uniroma1.it
0649970103 ext. +39
Francesco Violi, MD
study chair · Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161
Lorenzo Loffredo, MD
study director · Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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