Impact Analysis of Prognostic Stratification for Pulmonary Embolism

NCT03002467 | Terminated

• 1 other identifier: iAPP study
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.to demonstrate that the use of DOACs will reduce the duration of hospital stay of PE patients
4. 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

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Up to 3 months

Study Arms (2)

PESI score

EXPERIMENTAL

treating physicians must formally calculate PESI and report in the clinical record form\* each day of hospitalization on top of routine clinical practice (standard care)

Other: PESI score

Standard care

NO INTERVENTION

standard care (i.e. no formally calculation of PESI on top)

Interventions

PESI score OTHER

PESI score

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients with objectively diagnosed PE, both suspected or unsuspected (e.g. during CT for cancer staging and/or follow-up)
• Age \> 18 years
• Signature of written informed consent

You may not qualify if:

• Children

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Unknown Facility

Cuneo, Italy

Location

Related Publications (1)

• Donadini MP, Mumoli N, Fenu P, Pomero F, Re R, Palmiero G, Spadafora L, Mazzi V, Grittini A, Bertu L, Aujesky D, Dentali F, Ageno W, Squizzato A. The Clinical Impact of the Pulmonary Embolism Severity Index on the Length of Hospital Stay of Patients with Pulmonary Embolism: A Randomized Controlled Trial. Diagnostics (Basel). 2024 Apr 7;14(7):776. doi: 10.3390/diagnostics14070776.

  PMID: 38611689 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alessandro Squizzato, MD PhD

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2016
• First Posted: December 23, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

IT (1)