Clinical trial NCT03157843: Rate of Venous Thrombosis in Acutely Ill Patients Hospitalized in Internal Medicine Wards
Official title: Rate of Venous Thrombosis in Acutely Ill Patients Hospitalized in Internal Medicine Wards
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thromboembolism
Deep Venous Thrombosis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients hospitalised for acute medical illness

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.

Eligibility criteria: 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

Primary outcomes:
measure: Venous thrombo-embolism
timeFrame: Baseline, up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
Study officials:
affiliation: Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161
name: Francesco Violi, MD
role: STUDY_CHAIR
affiliation: Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161
name: Lorenzo Loffredo, MD
role: STUDY_DIRECTOR
References: