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

Chronic Obstructive Pulmonary Disease Clinical Trial

— PEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035293
• Other study ID #: PEP
• Secondary ID: RB 13-087 [CHRU
• Status: Completed
• Phase: N/A
• First received: January 3, 2014
• Last updated: December 27, 2017
• Start date: January 8, 2014
• Est. completion date: October 13, 2017

Study information

• Verified date: December 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: October 13, 2017
• Est. primary completion date: October 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Embolism
• Lung Diseases
• Lung Diseases, Obstructive
• Patients Hospitalized for a COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Embolism

Intervention

Other:
• PEP

Locations

Country	Name	City	State
France	CHU	Angers
France	CHRU de Brest	Brest
France	HIA	Brest
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Européen Georges Pompidou	Paris
France	CH de Cornouaille Quimper	Quimper
France	Hôpital Nord	St-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.		27 months
Secondary	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