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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
746
If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital La Coruña
A Coruña, Spain
Hospital Galdakao
All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.
Time frame: 90-day follow-up
All-cause Mortality
All-cause mortality.
Time frame: 90-day follow-up
Symptomatic Recurrent Venous Thromboembolism
Symptomatic venous thromboembolic recurrence confirmed by objective testing.
Time frame: 90-day follow-up
Hospitalization
Need for readmission.
Time frame: 90-day follow-up
Major Bleeding
Major bleeding (defined according to previously published criteria)
Time frame: 90-day follow-up
Clinically Relevant Non Major Bleeding
Clinically relevant non major bleeding (defined according to previously published criteria)
Time frame: 90-day follow-up
Serious Adverse Events
Serious adverse events.
Time frame: 90-day follow-up
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Barakaldo, Spain
Clinica Nostra Senyora del Remei
Barcelona, Spain
Hospital Capio Sagrat Cor
Barcelona, Spain
Hospital Cruces
Bilbao, Spain
Hospital San Pedro
Logroño, Spain
Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University
Madrid, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Alcorcon
Madrid, Spain
...and 9 more locations