The Use of Risk Scores for Thromboprophylaxis in Medically Ill Patients-Rationale and Design of the RICO trial
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/ )..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:8 |
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| Enthalten in: |
TH open : companion journal to thrombosis and haemostasis - 8(2024), 1 vom: 01. Jan., Seite e55-e60 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Dentali, Francesco [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Revised 16.01.2024 published: Electronic-eCollection ClinicalTrials.gov: NCT04267718 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1055/a-2209-4708 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM367125943 |
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| 520 | |a 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/ ). | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a RAMs | |
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| 650 | 4 | |a thromboprophylaxis | |
| 650 | 4 | |a venous thromboembolism | |
| 700 | 1 | |a Campanini, Mauro |e verfasserin |4 aut | |
| 700 | 1 | |a Bonaventura, Aldo |e verfasserin |4 aut | |
| 700 | 1 | |a Fontanella, Luca |e verfasserin |4 aut | |
| 700 | 1 | |a Zuretti, Francesca |e verfasserin |4 aut | |
| 700 | 1 | |a Tavecchia, Luca |e verfasserin |4 aut | |
| 700 | 1 | |a Mumoli, Nicola |e verfasserin |4 aut | |
| 700 | 1 | |a Gnerre, Paola |e verfasserin |4 aut | |
| 700 | 1 | |a Ventrella, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Giustozzi, Michela |e verfasserin |4 aut | |
| 700 | 1 | |a Valerio, Antonella |e verfasserin |4 aut | |
| 700 | 1 | |a Fontanella, Andrea |e verfasserin |4 aut | |
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