We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified January 2017 by University Hospital, Brest
Sponsor:
ClinicalTrials.gov Identifier:
NCT02035293
First Posted: January 14, 2014
Last Update Posted: January 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Brest
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Patients Hospitalized for a COPD Exacerbation Other: PEP Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD. [ Time Frame: 27 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 750
Study Start Date: January 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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;

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035293


Contacts
Contact: Francis COUTURAUD, PU-PH francis.couturaud@chu-brest.fr

Locations
France
CHU Recruiting
Angers, France
Contact: Pierre-Marie ROY    02 41 35 37 18    PMRoy@chu-angers.fr   
CHRU de Brest Recruiting
Brest, France, 29200
Contact: Francis COUTURAUD, PU-PH       francis.couturaud@chu-brest.fr   
HIA Recruiting
Brest, France, 29240
Contact: NICOLAS PALEIRON    02 98 43 73 01    nicolas.paleiron@free.fr   
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Jeannot SCHMIDT, Pr       jschmidt@chu-clermontferrand.fr   
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Guy MEYER    01 56 09 34 62    guy.meyer@egp.aphp.fr   
CH de Cornouaille Quimper Recruiting
Quimper, France, 29107
Contact: Yannick AUFFRET, Dr       yannickauffret@voila.fr   
Hôpital Nord Recruiting
St-Etienne, France, 42055
Contact: Laurent BERTOLETTI, Dr       laurent.bertoletti@gmail.com   
Principal Investigator: Laurent BERTOLETTI         
Sub-Investigator: Patrick MISMETTI         
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Francis COUTURAUD, PU-PH CHRU de Brest
  More Information

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02035293     History of Changes
Other Study ID Numbers: PEP
RB 13-087 [CHRU Brest]
First Submitted: January 3, 2014
First Posted: January 14, 2014
Last Update Posted: January 16, 2017
Last Verified: January 2017

Keywords provided by University Hospital, Brest:
COPD Exacerbation
Pulmonary embolism
Standardized and consensus diagnostic strategy

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Embolism
Pulmonary Embolism
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases