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

University of Roma La Sapienza

Status: Unknown

Conditions: Venous Thromboembolism; Deep Venous Thrombosis

Treatments: Drug: low-molecular-weight heparin

Study type: Observational

Funder types: Other

Identifiers

NCT03157843

AURELIO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Medical Patients

Description:

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

Treatment:

Drug: low-molecular-weight heparin

Control Group

Description:

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