MedTrace Logo

Impact Analysis of Prognostic Stratification for Pulmonary Embolism

NCT03002467 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2020-11-17

No results posted yet for this study

Summary

The Investigator postulate that the use of PESI in addition to routine clinical practice, as opposed to routine clinical practice based on clinical judgment alone, will help physicians to correctly identify PE patients at low-risk of adverse outcomes. Considered that low-risk patients could benefit from a short hospital stay, aim of this study is to demonstrate that the use of PESI will lead physicians to discharge these patients earlier, thus reducing the duration of hospital stay of PE patients (primary outcome).

Outpatients diagnosed with PE at the emergency department (ED) and admitted to participating units represent the target population

As the availability of DOACs may influence the duration of hospital stay, the secondary objectives of the present study are:

1. to demonstrate that a shorter hospital stay for low-risk PE patients (independently on the method used to identify them) will reduce the incidence of hospital-associated complications and improve patients satisfaction and quality of life, without increasing the incidence of PE-related complications
2. to demonstrate that the use of PESI, as opposed to clinical judgment alone, will be associated with a greater proportion of patients discharged early (\< 72 hours from ED admission) or treated entirely at home (\< 24 hours from ED admission).
3. to demonstrate that the use of DOACs will reduce the duration of hospital stay of PE patients
4. to demonstrate that the use of DOACs, as opposed to standard treatment, will be associated with a greater proportion of patients discharged early (\< 72 hours from ED admission) or treated entirely at home (\< 24 hours from ED admission).

Conditions

Interventions

OTHER

PESI score

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    lead OTHER

Principal Investigators

  • Alessandro Squizzato, MD PhD · Università degli Studi dell'Insubria

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002467 on ClinicalTrials.gov