| Registry | NCT03157843, acronym AURELIO |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 1000 (Estimated) |
| Sponsor | University of Roma La Sapienza (Other) |
| Conditions | Venous Thromboembolism, Deep Venous Thrombosis |
| Interventions | low-molecular-weight heparin (Drug) |
| Dates | start 2015-02-01, primary completion 2017-12-01 (estimated), completion 2018-01-01 (estimated), first posted 2017-05-17, last updated 2017-05-17 |
| Locations | 1 site in Italy |
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All trials for Venous Thromboembolism All trials for Deep Venous Thrombosis All trials of low-molecular-weight heparin
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Medical Patients | Drug: low-molecular-weight heparin | Medical patients who received, at admission and during all the length of recovery, antithrombotic drugs (low-molecular-weight heparin at prophylactic dosage ). | |
| Control Group | Medical patients not treated with antithrombotic drugs during the recovery. Subjects age, sex and comorbidities matched. |
Sex: All, ages: 18 Years to 90 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Sapienza University of Rome | Rome | Italy | Recruiting |