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. (see Contacts and Locations)
Verified July 2014 by University Hospital, Brest
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT02035293
First received: January 3, 2014
Last updated: July 29, 2014
Last verified: July 2014
  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: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: January 2014
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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   
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Guy MEYER    01 56 09 34 62    guy.meyer@egp.aphp.fr   
Hôpital Nord Recruiting
St-Etienne, France, 42055
Contact: Patrick MISMETTI    04 77 12 02 85    patrick.mismetti@chu-st-etienne.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Francis COUTURAUD, PU-PH CHRU de Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02035293     History of Changes
Other Study ID Numbers: PEP, RB 13-087 [CHRU Brest]
Study First Received: January 3, 2014
Last Updated: July 29, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on September 22, 2014