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

• Conditions: Venous Thromboembolism; Deep Venous Thrombosis
• Interventions: Drug: low-molecular-weight heparin

• Registration Number: NCT03157843
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-10-09
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medical Patients	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 ).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Rome, Italy