Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients
- Conditions
- Prevention of Venous Thromboembolism
- Interventions
- Other: Application of Padua and IMPROVE Bleeding scores
- Registration Number
- NCT04267718
- Lead Sponsor
- Fadoi Foundation, Italy
- Brief 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2878
- Age ≥18 years
- Hospitalized for any cause in Internal Medicine
- Signature of informed consent
- Expected hospital stay < 48 h
- Any indication for anticoagulant therapy
- Life expectancy < 90 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with the Padua and IMPROVE Bleeding scores Application of Padua and IMPROVE Bleeding scores 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.
- Primary Outcome Measures
Name Time Method The percentage of patients with major complications at a 90-day follow-up 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
- Secondary Outcome Measures
Name Time Method Clinical outcomes at hospital discharge Time of hospitalization until discharge, up to 5 weeks 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
Number of patients with antithrombotic prophylaxis during hospital stay and at discharge. Time of hospitalization until discharge, up to 5 weeks 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
Trial Locations
- Locations (34)
Ospedale di Casale Monferrato
🇮🇹Casale Monferrato, Alessandria, Italy
Ospedale "SS Antonio e Margherita"
🇮🇹Tortona, Alessandria, Italy
Ospedale di Molfetta
🇮🇹Molfetta, Bari, Italy
Ospedale Civile
🇮🇹Legnano, Milano, Italy
Ospedale di Ceva
🇮🇹Ceva, Cuneo, Italy
Ospedale di Magenta
🇮🇹Magenta, Milano, Italy
Ospedale di Mondovì
🇮🇹Mondovì, Cuneo, Italy
Ospedale di Rivoli
🇮🇹Rivoli, Torino, Italy
Ospedale "Beato Angelo"
🇮🇹Cosenza, Italy
Ospedale di Cremona
🇮🇹Cremona, Italy
E.O. Ospedali Galliera
🇮🇹Genova, Italy
Ospedale Santa Croce di Fano
🇮🇹Fano, Italy
Azienda Ospedaliera "Cardarelli"
🇮🇹Napoli, Italy
Ospedale Maggiore Niguarda
🇮🇹Milano, Italy
Ospedale Fatebenefratelli
🇮🇹Napoli, Italy
Ospedale Silvestrini di Perugia
🇮🇹Perugia, Italy
Ospedale "Bianchi-Melacrino-Morelli"
🇮🇹Reggio Calabria, Italy
Ospedale "San Paolo"
🇮🇹Savona, Italy
Ospedale di Treviso
🇮🇹Treviso, Italy
Ospedale "S. Giovanni Addolorata"
🇮🇹Roma, Italy
Ospedale "Vannini"
🇮🇹Roma, Italy
Ospedale di Circolo "Macchi"
🇮🇹Varese, Italy
Ospedale Sant'Andrea
🇮🇹Vercelli, Italy
Ospedale "S. Bortolo"
🇮🇹Vicenza, Italy
Ospedale di Borgosesia
🇮🇹Borgosesia, Vercelli, Italy
Ospedale Cardinal Massaia
🇮🇹Asti, Italy
Ospedale di Senigallia
🇮🇹Senigallia, Ancona, Italy
Ospedale Generale di Zona
🇮🇹Lagonegro, Potenza, Italy
Ospedale Media Valle del Tevere
🇮🇹Todi, Perugia, Italy
Ospedale San Marco
🇮🇹Grottaglie, Taranto, Italy
Ospedale San Giacomo Apostolo
🇮🇹Castelfranco Veneto, Treviso, Italy
Osp. Casa Sollievo Della Sofferenza
🇮🇹San Giovanni Rotondo, Foggia, Italy
Ospedale di Conegliano Veneto
🇮🇹Conegliano, Treviso, Italy
Ospedale "Luini Confalonieri"
🇮🇹Luino, Varese, Italy