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Clinical Trials/NCT02035293
NCT02035293CompletedNot Applicable

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

University Hospital, Brest13 sites in 1 country750 target enrollmentStarted: January 8, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
750
Locations
13
Primary Endpoint
Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

PEP

Other

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: PEP (Other)

Outcomes

Primary Outcomes

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

Time Frame: 27 months

Secondary Outcomes

  • 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(27 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (13)

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