Pulmonary Embolism as a Cause of COPD Exacerbations (SLICE)
Pulmonary Embolism, Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring Venous thromboembolism, COPD exacerbations, Anticoagulation, Mortality
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.
Sites / Locations
- Hospital Germans Trias i Pujol
- Hospital Galdakao
- Clinica Nostra Senyora del Remei
- Hospital Capio Sagrat Cor
- Hospital Cruces
- Hospital La Coruña
- Hospital San Pedro
- Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University
- Fundacion Jimenez Diaz
- Hospital Alcorcon
- Hospital Doce de Octubre
- Hospital Gregorio Marañon
- Hospital La Paz
- Complejo Hospitalario Pontevedra
- Hospital Marques de Valdecilla
- Policlinico La Rosaleda
- Hospital Virgen del Rocio
- Hospital Txagorritxu
- Hospital Lozano Blesa
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Active search for pulmonary embolism
Standard management
All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.
All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.