Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients
RICO
1 other identifier
interventional
2,878
1 country
35
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2019
CompletedFirst Submitted
Initial submission to the registry
September 13, 2019
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedFebruary 28, 2024
February 1, 2024
2.2 years
September 13, 2019
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Clinical outcomes at hospital discharge
Time of hospitalization until discharge, up to 5 weeks
Number of patients with antithrombotic prophylaxis during hospital stay and at discharge.
Time of hospitalization until discharge, up to 5 weeks
Study Arms (2)
Patients with the Padua and IMPROVE Bleeding scores
EXPERIMENTALA 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 INTERVENTIONA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Hospitalized for any cause in Internal Medicine
- Signature of informed consent
You may not qualify if:
- Expected hospital stay \< 48 h
- Any indication for anticoagulant therapy
- Life expectancy \< 90 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Ospedale di Casale Monferrato
Casale Monferrato, Alessandria, Italy
Ospedale "SS Antonio e Margherita"
Tortona, Alessandria, Italy
Ospedale di Senigallia
Senigallia, Ancona, Italy
Ospedale di Molfetta
Molfetta, Bari, Italy
Ospedale Civile
Marcianise, Caserta, Italy
Ospedale di Ceva
Ceva, Cuneo, Italy
Ospedale di Mondovì
Mondovì, Cuneo, Italy
Osp. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Ospedale Civile
Legnano, Milano, Italy
Ospedale di Magenta
Magenta, Milano, Italy
Ospedale Media Valle del Tevere
Todi, Perugia, Italy
Ospedale Generale di Zona
Lagonegro, Potenza, Italy
Ospedale San Marco
Grottaglie, Taranto, Italy
Ospedale di Rivoli
Rivoli, Torino, Italy
Ospedale San Giacomo Apostolo
Castelfranco Veneto, Treviso, Italy
Ospedale di Conegliano Veneto
Conegliano, Treviso, Italy
Ospedale "Luini Confalonieri"
Luino, Varese, Italy
Ospedale di Borgosesia
Borgosesia, Vercelli, Italy
Ospedale Cardinal Massaia
Asti, 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 Maggiore Niguarda
Milan, Italy
Azienda Ospedaliera "Cardarelli"
Napoli, Italy
Ospedale Fatebenefratelli
Napoli, Italy
Ospedale Silvestrini di Perugia
Perugia, Italy
Ospedale "Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Ospedale "S. Giovanni Addolorata"
Roma, Italy
Ospedale "Vannini"
Roma, Italy
Ospedale "San Paolo"
Savona, Italy
Ospedale di Treviso
Treviso, Italy
Ospedale di Circolo "Macchi"
Varese, Italy
Ospedale Sant'Andrea
Vercelli, Italy
Ospedale "S. Bortolo"
Vicenza, Italy
Related Publications (1)
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.
PMID: 38222040DERIVED
Study Officials
- STUDY DIRECTOR
Mauro Campanini
Fadoi Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2019
First Posted
February 13, 2020
Study Start
March 20, 2019
Primary Completion
May 30, 2021
Study Completion
September 30, 2023
Last Updated
February 28, 2024
Record last verified: 2024-02