Status:
COMPLETED
Pulmonary Embolism as a Cause of COPD Exacerbations
Lead Sponsor:
Ministry of Health, Spain
Collaborating Sponsors:
American College of Chest Physicians
Sociedad Española de Neumología y Cirugía Torácica
Conditions:
Pulmonary Embolism
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
746 Patients enrolled
Trial Details
Trial ID
NCT02238639
Start Date
October 1 2014
End Date
December 1 2020
Last Update
December 1 2022
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
2
Hospital La Coruña
A Coruña, Spain
3
Hospital Galdakao
Barakaldo, Spain
4
Clinica Nostra Senyora del Remei
Barcelona, Spain