NCT02035293

Brief Summary

A standardized diagnostic strategy of pulmonary embolism will be applied to eligible patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed for 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

7 active sites

Status
completed

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

January 3, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

January 8, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2017

Completed
Last Updated

December 3, 2025

Status Verified

December 1, 2017

Enrollment Period

3.8 years

First QC Date

January 3, 2014

Last Update Submit

November 26, 2025

Conditions

Chronic Obstructive Pulmonary DiseasePatients Hospitalized for a COPD Exacerbation

Keywords

COPD ExacerbationPulmonary embolismStandardized and consensus diagnostic strategy

Outcome Measures

Primary Outcomes (1)

  • Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.

    27 months

Secondary Outcomes (1)

  • The rate of pulmonary embolism diagnosed during the 3 month follow-up in patients whom pulmonary embolism was initially excluded when they've been included in the study

    27 months

Study Arms (1)

PEP

OTHER

No drug and no placebo were used in this study. For all the patients who participated at the study PEP, only following exams must be performed: a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a chest multidetector-row CT angiography and venous ultrasound of the lower limbs

Other: PEP

Interventions

PEPOTHER
Also known as: No drug and no placebo were used in this study. For all the patients who participated at the study PEP, only exams must be performed;
PEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized for a COPD exacerbation
  • COPD previously diagnosed

You may not qualify if:

  • Allergy to iodinated contrast
  • Creatinine clearance \< 30 mL / min
  • Patient hospitalized for exacerbation of COPD for more than 48 hours
  • Pneumothorax
  • Exams impossible to be performed
  • Pregnancy
  • Life expectancy \< 3 months
  • Patients already receiving anticoagulant therapy for another reason (mechanical valve, cardiac arrhythmia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU

Angers, France

Location

CHRU de Brest

Brest, 29200, France

Location

HIA

Brest, 29240, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

CH de Cornouaille Quimper

Quimper, 29107, France

Location

Hôpital Nord

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • Couturaud F, Bertoletti L, Pastre J, Roy PM, Le Mao R, Gagnadoux F, Paleiron N, Schmidt J, Sanchez O, De Magalhaes E, Kamara M, Hoffmann C, Bressollette L, Nonent M, Tromeur C, Salaun PY, Barillot S, Gatineau F, Mismetti P, Girard P, Lacut K, Lemarie CA, Meyer G, Leroyer C; PEP Investigators. Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms. JAMA. 2021 Jan 5;325(1):59-68. doi: 10.1001/jama.2020.23567.

    PMID: 33399840RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Francis COUTURAUD, PU-PH

    CHRU de Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 14, 2014

Study Start

January 8, 2014

Primary Completion

October 13, 2017

Study Completion

October 13, 2017

Last Updated

December 3, 2025

Record last verified: 2017-12

Locations

FR(7)