search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Patients Hospitalized for a COPD Exacerbation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PEP
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD Exacerbation, Pulmonary embolism, Standardized and consensus diagnostic strategy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU
  • CHRU de Brest
  • HIA
  • CHU Clermont-Ferrand
  • Hôpital Européen Georges Pompidou
  • CH de Cornouaille Quimper
  • Hôpital Nord

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PEP

Arm Description

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

Outcomes

Primary Outcome Measures

Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.

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

Full Information

First Posted
January 3, 2014
Last Updated
December 27, 2017
Sponsor
University Hospital, Brest
search

1. Study Identification

Unique Protocol Identification Number
NCT02035293
Brief Title
Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Acronym
PEP
Official Title
Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2014 (Actual)
Primary Completion Date
October 13, 2017 (Actual)
Study Completion Date
October 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Patients Hospitalized for a COPD Exacerbation
Keywords
COPD Exacerbation, Pulmonary embolism, Standardized and consensus diagnostic strategy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEP
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
PEP
Other Intervention Name(s)
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;
Primary Outcome Measure Information:
Title
Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.
Time Frame
27 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis COUTURAUD, PU-PH
Organizational Affiliation
CHRU de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Angers
Country
France
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
HIA
City
Brest
ZIP/Postal Code
29240
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CH de Cornouaille Quimper
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
Hôpital Nord
City
St-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs