Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Patients Hospitalized for a COPD Exacerbation
• Interventions: Other: PEP

• Registration Number: NCT02035293
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-03
• Study Start: 2014-01-08
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Primary Completion: 2017-10-13
• Study Completion: 2017-10-13
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Patients hospitalized for a COPD exacerbation
• COPD previously diagnosed

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEP	PEP	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

Primary Outcome Measures

Name	Time	Method
Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.	27 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

CHU; 🇫🇷 Angers, France

HIA; 🇫🇷 Brest, France

CHRU de Brest; 🇫🇷 Brest, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CH de Cornouaille Quimper; 🇫🇷 Quimper, France

Hôpital Nord; 🇫🇷 St-Etienne, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France