Efficacy and Safety of an Active Strategy for the Diagnosis and Treatment of Acute Pulmonary Embolism (PE) in Patients With Unexplained Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): a Randomized Clinical Trial

Ministry of Health, Spain19 sites in 1 country746 target enrollmentOctober 2014

ConditionsPulmonary Embolism Chronic Obstructive Pulmonary Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Embolism
Sponsor: Ministry of Health, Spain
Enrollment: 746
Locations: 19
Primary Endpoint: All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective is to demonstrate the clinical benefits of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.

The secondary objective is to assess the safety of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

December 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ministry of Health, Spain

Responsible Party

Principal Investigator

David Jimenez

Senior Consultant

Ministry of Health, Spain

Eligibility Criteria

Inclusion Criteria

•Confirmation of COPD according to SEPAR-ALT criteria: post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) \< 0.7;
•Hospital admission because COPD exacerbation without initial clinical suspicion of PE in the Emergency Department (according by the Emergency Department physician evaluation).

Exclusion Criteria

•Contraindication to multidetector computed tomographic angiography (allergy to intravenous contrast medium, or renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula)
•Informed consent denied
•Pregnancy
•Life expectancy less than 3 months
•Anticoagulant therapy at the time of hospital admission
•Diagnosis of pneumothorax, or pneumonia (fever, and purulent sputum, and new infiltrate in chest X-ray)
•Diagnosis of lower respiratory tract infection (fever \[\>37.8ºC\], increased sputum volume and/or increased sputum purulence).
•Indication of invasive mechanical ventilation at the time of hospital admission;
•Impossibility for follow-up.