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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Unknown status

CT.gov ID

NCT03157843

Collaborator

(none)

1,000

Enrollment

Location

Duration (Months)

28.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism Deep Venous Thrombosis	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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Venous thrombo-embolism [Baseline, up to 4 weeks]
Evaluation of deep venous thrombosis by compression ultrasonography (CUS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sapienza University of Rome	Rome		Italy	00161

Sponsors and Collaborators

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