NCT03157843

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

October 9, 2016

Last Update Submit

May 16, 2017

Conditions

Venous ThromboembolismDeep Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Venous thrombo-embolism

    Evaluation of deep venous thrombosis by compression ultrasonography (CUS)

    Baseline, up to 4 weeks

Study Arms (2)

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

low-molecular-weight heparinDRUG
Medical Patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients hospitalised for acute medical illness

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza University of Rome

Rome, 00161, Italy

RECRUITING

Related Publications (1)

  • Loffredo L, Vidili G, Sciacqua A, Cogliati C, Di Giulio R, Bernardini S, Ciacci P, Pietrangelo A, Orlando F, Paraninfi A, Boddi M, Di Minno G, Falsetti L, Lodigiani C, Santoliquido A, Ettorre E, Pignatelli P, Arezzo MF, Gutu E, Harenberg J, Violi F; AURELIO Study Group. Asymptomatic and symptomatic deep venous thrombosis in hospitalized acutely ill medical patients: risk factors and therapeutic implications. Thromb J. 2022 Nov 30;20(1):72. doi: 10.1186/s12959-022-00433-8.

    PMID: 36451162DERIVED

MeSH Terms

Conditions

Venous ThromboembolismVenous Thrombosis

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosis

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Francesco Violi, MD

    Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161

    STUDY CHAIR

  • Lorenzo Loffredo, MD

    Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161

    STUDY DIRECTOR

Central Study Contacts

Francesco Violi, MD

CONTACT

064461933francesco.violi@uniroma1.it

Lorenzo Loffredo, MD

CONTACT

0649970103lorenzo.loffredo@uniroma1.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor, MD

Study Record Dates

First Submitted

October 9, 2016

First Posted

May 17, 2017

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

May 17, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)