Pulmonary Embolism as a Cause of COPD Exacerbations

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT02238639
• Date of registration: 09/09/2014
• Prospective Registration: Yes
• Primary sponsor: Ministry of Health, Spain
• Public title: Pulmonary Embolism as a Cause of COPD Exacerbations SLICE
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 746
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02238639
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Remedios Otero, MD, PhD
• Affiliation: Hospital Virgen del Rocio

• Name: Manuel Monreal, MD, PhD
• Affiliation: Germans Trias i Pujol Hospital

• Name: Alvar Agusti, MD, PhD
• Affiliation: Hospital Clinic

• Name: David Jimenez, MD, PhD
• Affiliation: IRYCIS, Alcala de Henares University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Pulmonary Embolism

Intervention(s)

Procedure: Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).

Primary Outcome(s)

All-cause mortality, symptomatic venous thromboembolism recurrence, or need for readmission. [Time Frame: 90-day follow-up]

Secondary Outcome(s)

Hospitalization [Time Frame: 90-day follow-up]

All-cause mortality [Time Frame: 90-day follow-up]

Clinically relevant non major bleeding [Time Frame: 90-day follow-up]

Major bleeding [Time Frame: 90-day follow-up]

Symptomatic recurrent venous thromboembolism [Time Frame: 90-day follow-up]

Serious adverse events [Time Frame: 90-day follow-up]

Secondary ID(s)

SLICE 1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sociedad Española de Neumología y Cirugía Torácica

American College of Chest Physicians