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

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.

Study Overview

• Status: Unknown
• Conditions: Venous Thromboembolism; Deep Venous Thrombosis
• Intervention / Treatment: Drug: low-molecular-weight heparin

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Recruiting
    • Sapienza University of Rome
    • Contact: Lorenzo Loffredo, MD; Phone Number: +39-06-49970103; Email: lorenzo.loffredo@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients hospitalised for acute medical illness

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous thrombo-embolism	Evaluation of deep venous thrombosis by compression ultrasonography (CUS)	Baseline, up to 4 weeks

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Chair: Francesco Violi, MD, Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161; Study Director: Lorenzo Loffredo, MD, Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: October 9, 2016
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: AURELIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No