Prevention of Venous ThromboembolismRICONCT04267718
Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients
A study testing Application of Padua and IMPROVE Bleeding scores in people with Prevention of Venous Thromboembolism, run by Fadoi Foundation, Italy at 35 sites in Italy.
Trial summary
FADOI (Italian Scientific Society of Hospital Internal Medicine) has planned to promote a multicenter cluster-randomized controlled clinical study in order to evaluate the effects of a systematic assessment of patients by using the Padua prediction score and the IMPROVE Bleeding score vs clinical judgement on the use… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Venous Thromboembolism
- What is being tested?
- Application of Padua and IMPROVE Bleeding scores
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,878 participants
- Where
- 35 sitesItaly
- Study dates
- 20 Mar 2019to 30 Sep 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Hospitalized for any cause in Internal Medicine
- Signature of informed consent
Who cannot join
- Expected hospital stay < 48 h
- Any indication for anticoagulant therapy
- Life expectancy < 90 days
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Italy35 sites
Ospedale Cardinal Massaia
Asti
Ospedale di Borgosesia
Borgosesia, Vercelli
Ospedale di Casale Monferrato
Casale Monferrato, Alessandria
Ospedale San Giacomo Apostolo
Castelfranco Veneto, Treviso
Ospedale di Ceva
Ceva, Cuneo
Ospedale di Conegliano Veneto
Conegliano, Treviso
Ospedale "Beato Angelo"
Cosenza
Ospedale di Cremona
Cremona
Ospedale Santa Croce di Fano
Fano
E.O. Ospedali Galliera
Genova
Ospedale San Marco
Grottaglie, Taranto
Ospedale Generale di Zona
Lagonegro, Potenza
Ospedale Civile
Legnano, Milano
Ospedale "Luini Confalonieri"
Luino, Varese
Ospedale di Magenta
Magenta, Milano
Ospedale Civile
Marcianise, Caserta
Ospedale Maggiore Niguarda
Milan
Ospedale di Molfetta
Molfetta, Bari
Ospedale di Mondovì
Mondovì, Cuneo
Azienda Ospedaliera "Cardarelli"
Naples
Ospedale Fatebenefratelli
Naples
Ospedale Silvestrini di Perugia
Perugia
Ospedale "Bianchi-Melacrino-Morelli"
Reggio Calabria
Ospedale di Rivoli
Rivoli, Torino
Ospedale "S. Giovanni Addolorata"
Roma
Ospedale "Vannini"
Roma
Osp. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Foggia
Ospedale "San Paolo"
Savona
Ospedale di Senigallia
Senigallia, Ancona
Ospedale Media Valle del Tevere
Todi, Perugia
Ospedale "SS Antonio e Margherita"
Tortona, Alessandria
Ospedale di Treviso
Treviso
Ospedale di Circolo "Macchi"
Varese
Ospedale Sant'Andrea
Vercelli
Ospedale "S. Bortolo"
Vicenza
About this study
Official title: Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients: the RICO Cluster-randomized Controlled Trial
FADOI (Italian Scientific Society of Hospital Internal Medicine) has planned to promote a multicenter cluster-randomized controlled clinical study in order to evaluate the effects of a systematic assessment of patients by using the Padua prediction score and the IMPROVE Bleeding score vs clinical judgement on the use of antithrombotic prophylaxis and clinical outcomes (thromboembolic and hemorrhagic events).
Read the detailed description
The most recent guidelines suggest the use of prophylaxis in patients with a high thromboembolic risk, while taking into account the risk of bleeding.
It is known that patients admitted for acute pathology have an eight-fold higher incidence of thromboembolic events than the general population.
The Padua Prediction Score (PPS) is currently considered the best score available for the evaluation of thromboembolic risk in hospitalized patients, while the IMPROVE score was developed and validated for the assessment of bleeding risk in the same population of hospitalized patients.
In a recent study, data from the real world showed us how many of the patients admitted in Internal Medicine were at high thrombotic risk according to PPS and almost 90% of these were simultaneously at low hemorrhagic risk according to the IMPROVE score: in these patients pharmacological prophylaxis could therefore be prescribed during a safe stay.
Until now only a small prospective monocentric quasi-randomized study has shown that the use of systematic PPS reduces the incidence of thromboembolic events (symptomatic and non-symptomatic) upon discharge, compared to clinical judgment alone.
For these reasons, FADOI Foundation has promoted a multicenter controlled randomized cluster study in a real-life context among patients admitted to medical area departments. The aim of the study will be to analyze the effects of a systematic evaluation of patients (in centers that do not require the use of any score for the evaluation of thromboembolic risk), using the Padua Prediction Score (PPS) and the IMPROVE Bleeding score vs only clinical judgment for the use of antithrombotic prophylaxis and clinical outcomes (thromboembolic and haemorrhagic events). The main objective of the study is therefore to evaluate the effectiveness of a systematic evaluation of the thromboembolic and hemorrhagic risk in reducing the number of major complications in patients admitted to Internal Medicine, at a 90-day follow-up after hospital discharge.
- Conditions
- Prevention of Venous Thromboembolism
- Being tested
- Application of Padua and IMPROVE Bleeding scores
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Padua and IMPROVE Bleeding scoresOther
Eligible patients hospitalized in centres randomized to the Experimental group will be evaluated, within 48 hours from admission to hospital, by means of the Padua predictive score and the IMPROVE Bleeding score.
| Study group | Role | What they receive |
|---|---|---|
| Patients with the Padua and IMPROVE Bleeding scores | Experimental | A number of centres will be randomized to systematically evaluate all eligible patients with the Padua and IMPROVE Bleeding scores within 48 h after hospitalization. Receives: Other: Application of Padua and IMPROVE Bleeding scores |
| Patients will be evaluated according to clinical judgment only | No intervention | A number of centres will be randomized to the Control arm of the study, in which patients will be evaluated for their thrombotic and hemorrhagic risk according to clinical judgment only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with major complications at a 90-day follow-up
The percentage of patients with major complications (death, venous thromboembolism, major bleeding) at a 90-day follow-up in the group of patients who will be evaluated by means of the Padua and IMPROVE Bleeding scores vs those evaluated according to clinical judgment only
Measured: 3 month from the discharge
Secondary outcomes (2)
Clinical outcomes at hospital discharge
The percentage of patients with major complications (death, venous thromboembolism, major bleeding) at hospital discharge in the group of patients who will be evaluated by means of the Padua and IMPROVE Bleeding scores vs those evaluated according to clinical judgment only
Measured: Time of hospitalization until discharge, up to 5 weeks
Number of patients with antithrombotic prophylaxis during hospital stay and at discharge.
All the clinical characteristics of the patient collected, are compared between the experimental group and the clinical judgment group to understand the choice of an antithrombotic prophylaxis
Measured: Time of hospitalization until discharge, up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start20 Mar 2019
- Primary completion30 May 2021
- Study completion30 Sep 2023
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 Prevention of Venous ThromboembolismStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group includes a number of centres that will be randomized to systematically evaluate all eligible patients with the Padua and IMPROVE Bleeding scores within 48 h after hospitalization. The control group includes A number of centres will be randomized to the Control arm of the study, in which patients will be evaluated for their thrombotic and hemorrhagic risk according to clinical judgment only.
- Masking
- None (open label)
- Enrolment
- 2,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauro Campanini, Study director, Fadoi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267718
- Sponsor's protocol ID
- FADOI.04.2018
- Acronym
- RICO
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dentali F, Campanini M, Bonaventura A, Fontanella L, Zuretti F, Tavecchia L, Mumoli N, Gnerre P, Ventrella F, Giustozzi M, Valerio A, Fontanella A. The Use of Risk Scores for Thromboprophylaxis in Medically Ill Patients-Rationale and Design of the RICO trial. TH Open. 2024 Jan 12;8(1):e55-e60. doi: 10.1055/a-2209-4708. eCollection 2024 Jan.
PubMed 38222040
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients: the RICO Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04267718
- Acronym / sponsor ID
- RICO / FADOI.04.2018
- Conditions
- Prevention of Venous Thromboembolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,878 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 13 Feb 2020 (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.
FADOI (Italian Scientific Society of Hospital Internal Medicine) has planned to promote a multicenter cluster-randomized controlled clinical study in order to evaluate the effects of a systematic assessment of patients by using the Padua prediction score and the IMPROVE Bleeding score vs clinical judgement on the use of antithrombotic prophylaxis and clinical outcomes (thromboembolic and hemorrhagic events).
Detailed description
The most recent guidelines suggest the use of prophylaxis in patients with a high thromboembolic risk, while taking into account the risk of bleeding.
It is known that patients admitted for acute pathology have an eight-fold higher incidence of thromboembolic events than the general population.
The Padua Prediction Score (PPS) is currently considered the best score available for the evaluation of thromboembolic risk in hospitalized patients, while the IMPROVE score was developed and validated for the assessment of bleeding risk in the same population of hospitalized patients.
In a recent study, data from the real world showed us how many of the patients admitted in Internal Medicine were at high thrombotic risk according to PPS and almost 90% of these were simultaneously at low hemorrhagic risk according to the IMPROVE score: in these patients pharmacological prophylaxis could therefore be prescribed during a safe stay.
Until now only a small prospective monocentric quasi-randomized study has shown that the use of systematic PPS reduces the incidence of thromboembolic events (symptomatic and non-symptomatic) upon discharge, compared to clinical judgment alone.
For these reasons, FADOI Foundation has promoted a multicenter controlled randomized cluster study in a real-life context among patients admitted to medical area departments. The aim of the study will be to analyze the effects of a systematic evaluation of patients (in centers that do not require the use of any score for the evaluation of thromboembolic risk), using the Padua Prediction Score (PPS) and the IMPROVE Bleeding score vs only clinical judgment for the use of antithrombotic prophylaxis and clinical outcomes (thromboembolic and haemorrhagic events). The main objective of the study is therefore to evaluate the effectiveness of a systematic evaluation of the thromboembolic and hemorrhagic risk in reducing the number of major complications in patients admitted to Internal Medicine, at a 90-day follow-up after hospital discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group includes a number of centres that will be randomized to systematically evaluate all eligible patients with the Padua and IMPROVE Bleeding scores within 48 h after hospitalization. The control group includes A number of centres will be randomized to the Control arm of the study, in which patients will be evaluated for their thrombotic and hemorrhagic risk according to clinical judgment only.
| Arm | Type | Receives |
|---|---|---|
| Patients with the Padua and IMPROVE Bleeding scores | Experimental | Other: Application of Padua and IMPROVE Bleeding scoresA number of centres will be randomized to systematically evaluate all eligible patients with the Padua and IMPROVE Bleeding scores within 48 h after hospitalization. |
| Patients will be evaluated according to clinical judgment only | No intervention | –A number of centres will be randomized to the Control arm of the study, in which patients will be evaluated for their thrombotic and hemorrhagic risk according to clinical judgment only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Hospitalized for any cause in Internal Medicine
- Signature of informed consent
Key exclusion criteria (3 listed)
- Expected hospital stay < 48 h
- Any indication for anticoagulant therapy
- Life expectancy < 90 days
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 |
|---|---|---|
| Application of Padua and IMPROVE Bleeding scoresEligible patients hospitalized in centres randomized to the Experimental group will be evaluated, within 48 hours from admission to hospital, by means of the Padua predictive score and the IMPROVE Bleeding score. | Other | Patients with the Padua and IMPROVE Bleeding scores |
Primary outcome
The percentage of patients with major complications at a 90-day follow-up
Time frame: 3 month from the discharge
The percentage of patients with major complications (death, venous thromboembolism, major bleeding) at a 90-day follow-up in the group of patients who will be evaluated by means of the Padua and IMPROVE Bleeding scores vs those evaluated according to clinical judgment only
2 secondary outcomes
Clinical outcomes at hospital discharge
Time frame: Time of hospitalization until discharge, up to 5 weeks
Number of patients with antithrombotic prophylaxis during hospital stay and at discharge.
Time frame: Time of hospitalization until discharge, up to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 38222040Dentali F, Campanini M, Bonaventura A, Fontanella L, Zuretti F, Tavecchia L, Mumoli N, Gnerre P, Ventrella F, Giustozzi M, Valerio A, Fontanella A. The Use of Risk Scores for Thromboprophylaxis in Medically Ill Patients-Rationale and Design of the RICO trial. TH Open. 2024 Jan 12;8(1):e55-e60. doi: 10.1055/a-2209-4708. eCollection 2024 Jan.
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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.
Mauro Campanini study director
Fadoi Foundation
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Padua and IMPROVE Bleeding scores in people with Prevention of Venous Thromboembolism, run by Fadoi Foundation, Italy at 35 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with major complications at a 90-day follow-up (time frame: 3 month from the discharge). 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 NCT04267718, 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 28 Feb 2024.