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COMPLETED
NCT06015529
NA

Diagnostic Strategy for Suspected Pulmonary Embolism Based on 4PEPS

Sponsor: University Hospital, Angers

View on ClinicalTrials.gov

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.

Official title: Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: SPEED&PEPS Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3084

Start Date

2023-11-29

Completion Date

2025-11-10

Last Updated

2026-07-17

Healthy Volunteers

No

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)

Locations (23)

Cliniques Bruxelles

Brussels, Belgium

CHU Liège

Liège, Belgium

CH Agen

Agen, France

CHU Angers

Angers, France

CH Argenteuil

Argenteuil, France

CH Arpajon

Arpajon, France

AP HP Clamart

Clamart, France

CHU Clermont Ferrand

Clermont-Ferrand, France

CHU Grenoble

Grenoble, France

CH La Rochelle

La Rochelle, France

CH Versailles

Le Chesnay, France

CHU Limoges

Limoges, France

CHU Lyon

Lyon, France

CHR Metz Thionville

Metz, France

CHU Nantes

Nantes, France

CHU Nice

Nice, France

GH Paris

Paris, France

CHU Poitiers

Poitiers, France

CH Rochefort

Rochefort, France

CHU Rouen

Rouen, France

CHU Toulouse

Toulouse, France

CHU Tours

Tours, France

CH Troyes

Troyes, France