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

NCT ID: NCT03157843

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-01-31

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.

Conditions

Venous Thromboembolism; Deep Venous Thrombosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Medical Patients

Medical patients who received, at admission and during all the length of recovery, antithrombotic drugs (low-molecular-weight heparin at prophylactic dosage ).

low-molecular-weight heparin

Intervention Type: DRUG

Control Group

Medical patients not treated with antithrombotic drugs during the recovery. Subjects age, sex and comorbidities matched.

No interventions assigned to this group

Interventions

low-molecular-weight heparin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Francesco Violi

Principal Investigator, Clinical Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Violi, MD

Role: STUDY_CHAIR

Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161

Lorenzo Loffredo, MD

Role: STUDY_DIRECTOR

Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161

Locations

Sapienza University of Rome

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Violi, MD

Role: CONTACT

francesco.violi@uniroma1.it

064461933 ext. +39

Lorenzo Loffredo, MD

Role: CONTACT

lorenzo.loffredo@uniroma1.it

0649970103 ext. +39

Facility Contacts

Francesco Violi, Full Prof

Role: primary

francesco.violi@uniroma1.it

+39-06-4461933

Lorenzo Loffredo, MD

Role: backup

lorenzo.loffredo@uniroma1.it

+39-06-49970103

References

Loffredo L, Vidili G, Sciacqua A, Cogliati C, Di Giulio R, Bernardini S, Ciacci P, Pietrangelo A, Orlando F, Paraninfi A, Boddi M, Di Minno G, Falsetti L, Lodigiani C, Santoliquido A, Ettorre E, Pignatelli P, Arezzo MF, Gutu E, Harenberg J, Violi F; AURELIO Study Group. Asymptomatic and symptomatic deep venous thrombosis in hospitalized acutely ill medical patients: risk factors and therapeutic implications. Thromb J. 2022 Nov 30;20(1):72. doi: 10.1186/s12959-022-00433-8.

Reference Type: DERIVED

PMID: 36451162 (View on PubMed)

Other Identifiers

AURELIO

Identifier Type: -

Identifier Source: org_study_id