Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients

Prevention of Venous Thromboembolism Clinical Trial

— RICO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267718
• Other study ID #: FADOI.04.2018
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Fadoi Foundation, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of antithrombotic prophylaxis and clinical outcomes (thromboembolic and hemorrhagic events).

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 information / eligibility

• Status: Completed
• Enrollment: 2878
• Est. completion date: September 30, 2023
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years

2. Hospitalized for any cause in Internal Medicine

3. Signature of informed consent

Exclusion Criteria:

1. Expected hospital stay < 48 h

2. Any indication for anticoagulant therapy

3. Life expectancy < 90 days

Related Conditions & MeSH terms

• Prevention of Venous Thromboembolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• Application of Padua and IMPROVE Bleeding scores
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.

Locations

Country	Name	City	State
Italy	Ospedale Cardinal Massaia	Asti
Italy	Ospedale di Borgosesia	Borgosesia	Vercelli
Italy	Ospedale di Casale Monferrato	Casale Monferrato	Alessandria
Italy	Ospedale San Giacomo Apostolo	Castelfranco Veneto	Treviso
Italy	Ospedale di Ceva	Ceva	Cuneo
Italy	Ospedale di Conegliano Veneto	Conegliano	Treviso
Italy	Ospedale "Beato Angelo"	Cosenza
Italy	Ospedale di Cremona	Cremona
Italy	Ospedale Santa Croce di Fano	Fano
Italy	E.O. Ospedali Galliera	Genova
Italy	Ospedale San Marco	Grottaglie	Taranto
Italy	Ospedale Generale di Zona	Lagonegro	Potenza
Italy	Ospedale Civile	Legnano	Milano
Italy	Ospedale "Luini Confalonieri"	Luino	Varese
Italy	Ospedale di Magenta	Magenta	Milano
Italy	Ospedale Civile	Marcianise	Caserta
Italy	Ospedale Maggiore Niguarda	Milano
Italy	Ospedale di Molfetta	Molfetta	Bari
Italy	Ospedale di Mondovì	Mondovì	Cuneo
Italy	Azienda Ospedaliera "Cardarelli"	Napoli
Italy	Ospedale Fatebenefratelli	Napoli
Italy	Ospedale Silvestrini di Perugia	Perugia
Italy	Ospedale "Bianchi-Melacrino-Morelli"	Reggio Calabria
Italy	Ospedale di Rivoli	Rivoli	Torino
Italy	Ospedale "S. Giovanni Addolorata"	Roma
Italy	Ospedale "Vannini"	Roma
Italy	Osp. Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Foggia
Italy	Ospedale "San Paolo"	Savona
Italy	Ospedale di Senigallia	Senigallia	Ancona
Italy	Ospedale Media Valle del Tevere	Todi	Perugia
Italy	Ospedale "SS Antonio e Margherita"	Tortona	Alessandria
Italy	Ospedale di Treviso	Treviso
Italy	Ospedale di Circolo "Macchi"	Varese
Italy	Ospedale Sant'Andrea	Vercelli
Italy	Ospedale "S. Bortolo"	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
Fadoi Foundation, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 month from the discharge
Secondary	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	Time of hospitalization until discharge, up to 5 weeks
Secondary	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	Time of hospitalization until discharge, up to 5 weeks