Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04267718
Other study ID # FADOI.04.2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06193863 - An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
Completed NCT03055026 - Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer. Phase 3
Completed NCT01184989 - Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate Phase 4
Recruiting NCT01072747 - Efficacy And Safety Of Unfractionated Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass Phase 3
Recruiting NCT01072955 - Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass Phase 3