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

Venous Thromboembolism Clinical Trial

— AURELIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03157843
• Other study ID #: AURELIO
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2016
• Last updated: May 16, 2017
• Start date: February 2015
• Est. completion date: January 2018

Study information

• Verified date: May 2017
• Source: University of Roma La Sapienza
• Contact: Francesco Violi, MD
• Phone: 064461933
• Email: francesco.violi[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• low-molecular-weight heparin

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thrombo-embolism	Evaluation of deep venous thrombosis by compression ultrasonography (CUS)	Baseline, up to 4 weeks