Rate of Venous Thrombosis in Acutely Ill Patients Hospitalized in Internal Medicine Wards
Overview
- Phase
- Not Applicable
- Intervention
- low-molecular-weight heparin
- Conditions
- Venous Thromboembolism
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Venous thrombo-embolism
- Last Updated
- 8 years ago
Overview
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.
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.
Investigators
Francesco Violi
Principal Investigator, Clinical Professor, MD
University of Roma La Sapienza
Eligibility Criteria
Inclusion Criteria
- •pneumonia
- •heart failure
- •Chronic Obstructive Pulmonary Disease
- •Kidney failure
- •atrial fibrillation
- •Urinary Tract Infection
- •arthritis
- •Diabetic Ketoacidosis
- •unstable angina
- •cirrhosis
Exclusion Criteria
- •treatment with vitamin k inhibitors
- •surgical interventions
- •deep venous thrombosis
- •pulmonary embolism
Arms & Interventions
Medical Patients
Medical patients who received, at admission and during all the length of recovery, antithrombotic drugs (low-molecular-weight heparin at prophylactic dosage ).
Intervention: low-molecular-weight heparin
Outcomes
Primary Outcomes
Venous thrombo-embolism
Time Frame: Baseline, up to 4 weeks
Evaluation of deep venous thrombosis by compression ultrasonography (CUS)