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

December 27, 2017 updated by: University Hospital, Brest
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU
      • Brest, France, 29200
        • CHRU de Brest
      • Brest, France, 29240
        • HIA
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Quimper, France, 29107
        • CH de Cornouaille Quimper
      • St-Etienne, France, 42055
        • Hôpital Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: PEP
Other Names:
  • 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.
Time Frame: 27 months
27 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 27 months
27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Francis COUTURAUD, PU-PH, CHRU de Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2014

Primary Completion (Actual)

October 13, 2017

Study Completion (Actual)

October 13, 2017

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

December 29, 2017

Last Update Submitted That Met QC Criteria

December 27, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP
  • RB 13-087 [CHRU Brest]

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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