MedTrace Logo

Diagnostic Strategy for Suspected Pulmonary Embolism Based on 4PEPS

NCT06015529 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3084

Last updated 2026-03-04

No results posted yet for this study

Summary

The increased use of diagnostic imaging and especially computed tomography pulmonary angiography in patients suspected of pulmonary embolism (PE) is an important point of concerns.

The goal of this pragmatic cluster-randomized trial is to compare the diagnostic strategy based on the four-level pulmonary embolism probability score (4PEPS) and current practices.

The main questions it aims to answer is: "Does the diagnostic strategy based on 4PEPS significantly reduce the use of thoracic imaging without increasing the risk of serious adverse events as compared to current diagnostic practices?" Patients suspected of having PE in the participating emergency departments will be included and followed for 90 days. In ten centers, the emergency physicians will apply the 4PEPS strategy and in ten other centers, the emergency physicians will be free to do as they see fit. Researchers will compare the two groups of patients to see if the rate of diagnostic thoracic imaging tests and the rate of adverse events related to diagnostic strategies will differ.

Conditions

Interventions

DIAGNOSTIC_TEST

4PEPS strategy

Physicians of the participating centers in the intervention group will have the recommendation to apply the 4PEPS strategy. Using 12 variables, 4PEPS defines four levels of CP that rule out a PE, namely 1. based only on clinical data (very low CP: PEPS \< 0), 2. based on a D-dimer level \< 1000 μg/L (low CP: PEPS ≥ 0 and \< 5), 3. based on a D-dimer level with an age-adjusted cut-off value (moderate CP: PEPS ≥ 5 and \<12), or 4. the diagnosis cannot reliably be ruled out based on a D-dimer test (high CP: PEPS ≥ 12)

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Pierre-Marie ROY, MD, PhD · University Hospital, Angers

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2025-05-15
Completion
2025-11-10

Countries

  • Belgium
  • France

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 NCT06015529 on ClinicalTrials.gov