Clinical trial NCT06015529: Diagnostic Strategy for Suspected Pulmonary Embolism Based on 4PEPS
Official title: Diagnostic Strategy for Suspected Pulmonary Embolism in Emergency Departments Based on the 4-Level Pulmonary Embolism Clinical Probability Score: SPEED&PEPS Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
suspected PE
diagnostic strategy
clinical probability
cluster-randomized trial
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-08-29
Enrollment: 2560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic cluster-randomized trial
Primary purpose: DIAGNOSTIC

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.

Detailed description: Several strategies have been devised to safely limit the use of thoracic imaging in patients suspected of pulmonary embolism (PE). However, they are based on different rules for clinical probability (CP) assessment, rendering their combination difficult. The four-level pulmonary embolism probability score (4PEPS) allows the combination of all other strategies using a single CP assessment. Methods and analysis: SPEED\&PEPS is a pragmatic cluster-randomized trial. After a preliminary period aimed to assess the possibility of inclusions and current practices in 23 Emergency Departments (ED), 20 EDs will be selected to participate to the active phase and randomization. Half of the centers will be allocated to the control group where physicians will be free to do as they see fit but they will be given the recommendation to apply a validated strategy. Half of the centers will be allocated to the interventional group where the physicians will be given the recommendation to apply the 4PEPS strategy. Patients with suspected PE will be included and followed for 90 days (anticipated number of patients to be included: 2560, 1280 in each arm). The primary objective will be to demonstrate that the application of the 4PEPS strategy by emergency physicians, in comparison to current practices, (i) does not increase the risk of serious events related to diagnostic strategies and (ii) significantly reduces the use of thoracic imaging. If successful, the SPEED\&PEPS trial will have an important impact for patients suspected of PE limiting their irradiation and for public health in substantial savings in terms of the direct cost of diagnostic investigations and the indirect cost of hospitalizations due to waiting times or delayed harmful effects. Funding: This work is funded by a French Public Health grant (PREPS-N 2019). The funding source plays no role in the study design, data collection, analysis, interpretation or the writing of the manuscript.

Eligibility criteria: Inclusion Criteria:

* 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 not including D-dimer test).
* Free, prior, and informed consent to participate in the study.

Exclusion Criteria:

* Age \< 18 years.
* Known result of a specific diagnostic examination for PE (D-dimer test, 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).
* Curative dose of anticoagulant in place for more than two days prior to inclusion.
* 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 incapable of giving free and informed consent.

Primary outcomes:
measure: Rate of serious clinical events in the 90 days following inclusion
timeFrame: 90 days
measure: Rate of diagnostic thoracic imaging
timeFrame: up to 72 hours following inclusion
Secondary outcomes:
measure: 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
timeFrame: 90 days
measure: Rate of thromboembolic events occurring in the 90 days following inclusion in patients for whom PE was ruled out in both groups
timeFrame: 90 days
measure: Rate of D-dimer measurement
timeFrame: up to 72 hours following inclusion
measure: Length of stay in ED
timeFrame: Up to Emergency Department discharge (assessed up to 48 hours)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Bruxelles
city: Liège
country: Belgium
facility: CHU Liège
city: Agen
country: France
facility: CH Agen
city: Angers
country: France
facility: CHU Angers
city: Argenteuil
country: France
facility: CH Argenteuil
city: Arpajon
country: France
facility: CH Arpajon
city: Clamart
country: France
facility: AP HP Clamart
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: La Rochelle
country: France
facility: CH La Rochelle
city: Le Chesnay
country: France
facility: CH Versailles
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: CHU Lyon
city: Metz
country: France
facility: CHR Metz Thionville
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: GH Paris
city: Poitiers
country: France
facility: CHU Poitiers
city: Rochefort
country: France
facility: CH Rochefort
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
city: Troyes
country: France
facility: CH Troyes
Study officials:
affiliation: University Hospital, Angers
name: Pierre-Marie ROY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Roy 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.
citation: Roy 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.