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

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ClinicalTrials.gov Identifier: NCT02035293
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Patients Hospitalized for a COPD Exacerbation Other: PEP Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: N/A
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)
Actual Study Start Date : January 8, 2014
Actual Primary Completion Date : October 13, 2017
Actual Study Completion Date : October 13, 2017

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Arms and Interventions
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Arm Intervention/treatment
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;


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

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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France
CHU
Angers, France
CHRU de Brest
Brest, France, 29200
HIA
Brest, France, 29240
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Hôpital Européen Georges Pompidou
Paris, France, 75015
CH de Cornouaille Quimper
Quimper, France, 29107
Hôpital Nord
St-Etienne, France, 42055
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Francis COUTURAUD, PU-PH CHRU de Brest
More Information
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02035293    
Other Study ID Numbers: PEP
RB 13-087 [CHRU Brest]
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Keywords provided by University Hospital, Brest:
COPD Exacerbation
Pulmonary embolism
Standardized and consensus diagnostic strategy
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Embolism
Embolism
 Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases