Pulmonary Embolism as a Cause of COPD Exacerbations (SLICE)
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|ClinicalTrials.gov Identifier: NCT02238639|
Recruitment Status : Completed
First Posted : September 12, 2014
Results First Posted : November 7, 2022
Last Update Posted : December 1, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism Chronic Obstructive Pulmonary Disease||Procedure: Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||746 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||October 2020|
|Actual Study Completion Date :||December 2020|
Experimental: Active search for pulmonary embolism
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.
Procedure: Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).
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.
No Intervention: Standard management
All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
- All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission. [ Time Frame: 90-day follow-up ]Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.
- All-cause Mortality [ Time Frame: 90-day follow-up ]All-cause mortality.
- Symptomatic Recurrent Venous Thromboembolism [ Time Frame: 90-day follow-up ]Symptomatic venous thromboembolic recurrence confirmed by objective testing.
- Hospitalization [ Time Frame: 90-day follow-up ]Need for readmission.
- Major Bleeding [ Time Frame: 90-day follow-up ]Major bleeding (defined according to previously published criteria)
- Clinically Relevant Non Major Bleeding [ Time Frame: 90-day follow-up ]Clinically relevant non major bleeding (defined according to previously published criteria)
- Serious Adverse Events [ Time Frame: 90-day follow-up ]Serious adverse events.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238639
|Study Chair:||David Jimenez, MD, PhD||IRYCIS, Alcala de Henares University|
|Study Chair:||Alvar Agusti, MD, PhD||Hospital Clinic|
|Study Chair:||Manuel Monreal, MD, PhD||Germans Trias i Pujol Hospital|
|Study Chair:||Remedios Otero, MD, PhD||Hospital Virgen del Rocio|
Documents provided by David Jimenez, Ministry of Health, Spain:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||David Jimenez, Senior Consultant, Ministry of Health, Spain|
|Other Study ID Numbers:||
|First Posted:||September 12, 2014 Key Record Dates|
|Results First Posted:||November 7, 2022|
|Last Update Posted:||December 1, 2022|
|Last Verified:||November 2022|
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Embolism and Thrombosis
Fibrin fragment D
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action