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CC BY 4.0 · TH Open 2024; 08(01): e55-e60
DOI: 10.1055/a-2209-4708
Original Article

The Use of Risk Scores for Thromboprophylaxis in Medically Ill Patients—Rationale and Design of the RICO trial

Francesco Dentali 
1   Division of Internal Medicine, Medical Center, Ospedale di Circolo & Fondazion Macchi, ASST Sette Laghi, Varese, Italy
2   Department of Medicine and Surgery, Insubria University, Varese, Italy
,
Mauro Campanini
3   Department of Internal Medicine, Hospital “Maggiore della Carità,” Novara, Italy
,
Aldo Bonaventura 
1   Division of Internal Medicine, Medical Center, Ospedale di Circolo & Fondazion Macchi, ASST Sette Laghi, Varese, Italy
,
Luca Fontanella
4   Department of Medicine, Ospedale Buonconsiglio Fatebenefratelli di Napoli, Naples, Italy
,
Francesca Zuretti
1   Division of Internal Medicine, Medical Center, Ospedale di Circolo & Fondazion Macchi, ASST Sette Laghi, Varese, Italy
,
Luca Tavecchia
1   Division of Internal Medicine, Medical Center, Ospedale di Circolo & Fondazion Macchi, ASST Sette Laghi, Varese, Italy
,
Nicola Mumoli 
5   Department of Internal Medicine, Azienda Socio Sanitaria Territoriale (ASST) Ovest Milanese, Magenta, Italy
,
Paola Gnerre
6   Internal Medicine, “San Paolo” Hospital, Savona, Italy
,
Francesco Ventrella
7   Department of Internal Medicine, Hospital “G. Tatarella”—ASL-FG, Cerignola, Italy
,
Michela Giustozzi
8   Internal Vascular and Emergency Medicine—Stroke Unit, University of Perugia, Perugia, Italy
,
Antonella Valerio
9   Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan, Italy
,
Andrea Fontanella
4   Department of Medicine, Ospedale Buonconsiglio Fatebenefratelli di Napoli, Naples, Italy
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Abstract

Background Venous thromboembolism (VTE) in hospitalized medically ill patients is a significant cause of morbidity and mortality. Guidelines suggest that VTE and bleeding risk assessment models (RAMs) should be integrated into the clinical decision-making process on thromboprophylaxis. However, poor evidence is available comparing the use of a RAM versus clinical judgement in evaluating VTE and bleeding occurrence.

Methods Reducing Important Clinical Outcomes in hospitalized medical ill patients (RICO) is a multicenter, cluster-randomized, controlled clinical trial (ClinicalTrials.gov Identifier: NCT04267718). Acutely ill patients hospitalized in Internal Medicine wards are randomized to the use of RAMs—namely the Padua Prediction Score and the International Medical Prevention Registry on Venous Thromboembolism Bleeding Score—or to clinical judgement. The primary study outcome is a composite of symptomatic objectively confirmed VTE and major bleeding at 90-day follow-up. Secondary endpoints include the evaluation of clinical outcomes at hospital discharge and the assessment of VTE prophylaxis prescription during the study period. In order to demonstrate a 50% reduction in the primary outcome in the experimental group and assuming an incidence of the primary outcome of 3.5% in the control group at 90-day; 2,844 patients across 32 centers will be included in the study.

Discussion The RICO trial is a randomized study of clinical management assessing the role of RAMs in hospitalized medical ill patients with the aim of reducing VTE and bleeding occurrence. The study has the potential to improve clinical practice since VTE still represents an important cause of morbidity and mortality in this setting.

Keywords

medical patients - venous thromboembolism - RAMs - major bleeding - thromboprophylaxis


Publication History

Received: 19 May 2022

Accepted: 22 August 2022

Accepted Manuscript online:
11 November 2023

Article published online:
12 January 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
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