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

Not Applicable

Completed

• Conditions: Prevention of Venous Thromboembolism

• 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.

Study Timeline

• Study Start: 2019-03-20
• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-13
• Primary Completion: 2021-05-30
• Study Completion: 2023-09-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2878

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 Senigallia; 🇮🇹 Senigallia, Ancona, Italy

Ospedale di Molfetta; 🇮🇹 Molfetta, Bari, Italy

Ospedale Civile; 🇮🇹 Legnano, Milano, Italy

Ospedale di Ceva; 🇮🇹 Ceva, Cuneo, Italy

Ospedale di Mondovì; 🇮🇹 Mondovì, Cuneo, Italy

Osp. Casa Sollievo Della Sofferenza; 🇮🇹 San Giovanni Rotondo, Foggia, Italy

Ospedale di Magenta; 🇮🇹 Magenta, Milano, Italy

Ospedale Media Valle del Tevere; 🇮🇹 Todi, Perugia, Italy

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