Pulmonary Embolism as a Cause of COPD Exacerbations
- Conditions
- Pulmonary EmbolismChronic Obstructive Pulmonary Disease
- Registration Number
- NCT02238639
- Lead Sponsor
- Ministry of Health, Spain
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 746
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission. 90-day follow-up Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.
- Secondary Outcome Measures
Name Time Method Serious Adverse Events 90-day follow-up Serious adverse events.
Hospitalization 90-day follow-up Need for readmission.
Major Bleeding 90-day follow-up Major bleeding (defined according to previously published criteria)
Clinically Relevant Non Major Bleeding 90-day follow-up Clinically relevant non major bleeding (defined according to previously published criteria)
All-cause Mortality 90-day follow-up All-cause mortality.
Symptomatic Recurrent Venous Thromboembolism 90-day follow-up Symptomatic venous thromboembolic recurrence confirmed by objective testing.
Trial Locations
- Locations (19)
Hospital Alcorcon
🇪🇸Madrid, Spain
Hospital Doce de Octubre
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Complejo Hospitalario Pontevedra
🇪🇸Pontevedra, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Clinica Nostra Senyora del Remei
🇪🇸Barcelona, Spain
Hospital Galdakao
🇪🇸Baracaldo, Spain
Hospital Capio Sagrat Cor
🇪🇸Barcelona, Spain
Hospital Cruces
🇪🇸Bilbao, Spain
Hospital San Pedro
🇪🇸Logroño, Spain
Hospital La Coruña
🇪🇸La Coruña, Spain
Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University
🇪🇸Madrid, Spain
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Spain
Policlinico La Rosaleda
🇪🇸Santiago de Compostela, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Txagorritxu
🇪🇸Vitoria, Spain
Hospital Lozano Blesa
🇪🇸Zaragoza, Spain