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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Patients | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-molecular-weight heparin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Venous thrombo-embolism | Evaluation of deep venous thrombosis by compression ultrasonography (CUS) | Baseline, up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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patients hospitalised for acute medical illness
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Violi, MD | Contact | 064461933 | +39 | francesco.violi@uniroma1.it |
| Lorenzo Loffredo, MD | Contact | 0649970103 | +39 | lorenzo.loffredo@uniroma1.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Violi, MD | Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161 | Study Chair |
| Lorenzo Loffredo, MD | Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome | Recruiting | Rome | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36451162 | Derived | 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. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| D013927 |
| Thrombosis |