Venous ThromboembolismAURELIONCT03157843
Rate of Venous Thrombosis in Acutely Ill Patients Hospitalized in Internal Medicine Wards
An observational study of Venous Thromboembolism and Deep Venous Thrombosis, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Venous Thromboembolism, Deep Venous Thrombosis
- What is being tested?
- low-molecular-weight heparin
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalised for acute medical illness
Who may be able to join
- pneumonia
- heart failure
- Chronic Obstructive Pulmonary Disease
- Kidney failure
- syncope
- atrial fibrillation
Show all 13Show fewer
- Urinary Tract Infection
- Anemia
- arthritis
- Diabetic Ketoacidosis
- unstable angina
- asthma
- cirrhosis
Who cannot join
- treatment with vitamin k inhibitors
- surgical interventions
- deep venous thrombosis
- pulmonary embolism
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Sapienza University of Rome
Rome, 00161
Francesco Violi, Full Prof, +39-06-4461933, francesco.violi@uniroma1.it
Lorenzo Loffredo, MD, +39-06-49970103, lorenzo.loffredo@uniroma1.it
About this study
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.
Read the 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
- Being tested
- low-molecular-weight heparin
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-molecular-weight heparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Medical Patients | Medical patients who received, at admission and during all the length of recovery, antithrombotic drugs (low-molecular-weight heparin at prophylactic dosage ). Receives: Drug: low-molecular-weight heparin | |
| Control Group | Medical patients not treated with antithrombotic drugs during the recovery. Subjects age, sex and comorbidities matched. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thrombo-embolism
Evaluation of deep venous thrombosis by compression ultrasonography (CUS)
Measured: Baseline, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startFeb 2015
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Violi, University of Roma La Sapienza
- Investigators
- Francesco Violi, MD, Study chair, Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161Lorenzo Loffredo, MD, Study director, Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157843
- Sponsor's protocol ID
- AURELIO
- Acronym
- AURELIO
- Status last verified
- May 2017
- First submitted
- 9 Oct 2016
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36451162
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Venous Thrombosis in Acutely Ill Patients Hospitalized in Internal Medicine Wards
- ClinicalTrials.gov ID
- NCT03157843
- Acronym / sponsor ID
- AURELIO / AURELIO
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Patients | – | Drug: low-molecular-weight heparinMedical 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalised for acute medical illness
Key inclusion criteria (13 listed)
- pneumonia
- heart failure
- Chronic Obstructive Pulmonary Disease
- Kidney failure
- syncope
Key exclusion criteria (4 listed)
- treatment with vitamin k inhibitors
- surgical interventions
- deep venous thrombosis
- pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-molecular-weight heparin | Drug | Medical Patients |
Primary outcome
Venous thrombo-embolism
Time frame: Baseline, up to 4 weeks
Evaluation of deep venous thrombosis by compression ultrasonography (CUS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 36451162Loffredo 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.
- Individual participant dataSharing planned: No
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Violi, MD study chair
Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161
Lorenzo Loffredo, MD study director
Internal and Medical Specialties Department, Policlinico Umberto I, Rome, Italy, 00161
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Deep Venous Thrombosis, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Violi, MD (064461933 ext. +39, francesco.violi@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thrombo-embolism (time frame: Baseline, up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.