Diagnostic Strategy for Suspected Pulmonary Embolism Based on 4PEPS
SPEED&PEPS
1 other identifier
interventional
3,084
2 countries
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Typical duration for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2023
CompletedFirst Posted
Study publicly available on registry
August 29, 2023
CompletedStudy Start
First participant enrolled
November 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2025
CompletedMarch 4, 2026
March 1, 2026
1.5 years
July 31, 2023
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of serious clinical events in the 90 days following inclusion
The primary safety endpoint will be the rate of serious clinical events in the 90 days following inclusion: • Serious adverse events related to diagnostic testing (leading to hospitalization or prolongation of hospitalization, permanent inability or incapacity, and death). • Symptomatic thromboembolic events in patients not diagnosed with PE in the emergency department or new thromboembolic events in patients diagnosed with PE. • Death related to PE (initial or recurrent PE). • Major bleeding related to an anticoagulant treatment prescribed for pulmonary embolism according to ISTH criteria.
90 days
Rate of diagnostic thoracic imaging
The primary efficacy endpoint will be the rate of thoracic imaging among all included patients with suspected PE. The following examinations are considered if they are performed at the request of the emergency physician in search of PE: computed tomography pulmonary angiography (CTPA), planar perfusion or perfusion-ventilation scintigraphy, and SPECT scintigraphy.
up to 72 hours following inclusion
Secondary Outcomes (4)
Rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out according to the 4PEPS strategy in the intervention group
90 days
Rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out in both groups
90 days
Rate of D-dimer measurement
up to 72 hours following inclusion
Length of stay in ED
Up to Emergency Department discharge (assessed up to 48 hours)
Study Arms (2)
Control group - current practices
NO INTERVENTIONThe investigating physicians of the participating centers in the control group will be free to provide care as they see fit. However, a reminder of national and European guidelines for PE management will be given to them and they will have the recommendation to apply a validated strategy. To make it easier, the different scores will be included in the clinical help-decision support software called SPEED. Investigators will be asked to enter data about the included patients directly into SPEED, which will act as the study's electronic case report form (eCRF). A paper version of the CRF will also be available.
Intervention group - 4PEPS strategy
ACTIVE COMPARATORPhysicians of the participating centers in the intervention group will have the recommendation to apply the 4PEPS strategy. To make it easier to apply, the 4PEPS score will be included in SPEED. Investigators will be asked to enter the information relating to patients included in the study directly into SPEED before performing any testing. Entering these data will enable the 4PEPS score to be calculated automatically and specific recommendations to be provided. A paper version of the CRF will also be available
Interventions
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)
Eligibility Criteria
You may qualify if:
- Admission to an emergency department participating in the study.
- Suspected PE due to thoracic symptoms (dyspnea, chest pain, or hemoptysis) and/or syncope without any other obvious explanation after clinical examination and possible additional first-line tests (ECG, chest X-ray, or routine lab work-up).
You may not qualify if:
- Age \< 18 years.
- Known result of a specific diagnostic imaging examination for PE (thoracic CT angiography, pulmonary scintigraphy, or venous ultrasound of the lower limbs).
- Hemodynamic instability (systolic blood pressure \< 90 mmHg or more than 40 mmHg lower than usual for more than 15 min).
- Pregnant or parturient patient.
- Patient in detention by judicial or administrative decision.
- Patient undergoing compulsory psychiatric treatment.
- Patient placed under a legal protection measure.
- Patient who objects to participating in the research (preliminary phase) or is unable to give free and informed consent (active phase).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Cliniques Bruxelles
Brussels, Belgium
CHU Liège
Liège, Belgium
CH Agen
Agen, France
CHU Angers
Angers, 49000, 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
Related Publications (3)
Roy PM, Friou E, Germeau B, Douillet D, Kline JA, Righini M, Le Gal G, Moumneh T, Penaloza A. Derivation and Validation of a 4-Level Clinical Pretest Probability Score for Suspected Pulmonary Embolism to Safely Decrease Imaging Testing. JAMA Cardiol. 2021 Jun 1;6(6):669-677. doi: 10.1001/jamacardio.2021.0064.
PMID: 33656522RESULTRoy PM, Durieux P, Gillaizeau F, Legall C, Armand-Perroux A, Martino L, Hachelaf M, Dubart AE, Schmidt J, Cristiano M, Chretien JM, Perrier A, Meyer G. A computerized handheld decision-support system to improve pulmonary embolism diagnosis: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):677-86. doi: 10.7326/0003-4819-151-10-200911170-00003.
PMID: 19920268RESULTRoy PM, Moumneh T, Penaloza A, Schmidt J, Charpentier S, Joly LM, Riou J, Douillet D. Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: Study Protocol of SPEED&PEPS Trial. Diagnostics (Basel). 2022 Dec 9;12(12):3101. doi: 10.3390/diagnostics12123101.
PMID: 36553108RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre-Marie ROY, MD, PhD
University Hospital, Angers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- blinded adjudication committee assessing endpoints
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2023
First Posted
August 29, 2023
Study Start
November 29, 2023
Primary Completion
May 15, 2025
Study Completion
November 10, 2025
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The study protocol is already published and available (doi: 10.3390/diagnostics12123101). The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.