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OpenTrials
Completed

NCT Number: NCT02238639

Pulmonary Embolism as a Cause of COPD Exacerbations

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. All-cause Mortality

    Time frame: 90-day follow-up

    All-cause mortality.

  2. Symptomatic Recurrent Venous Thromboembolism

    Time frame: 90-day follow-up

    Symptomatic venous thromboembolic recurrence confirmed by objective testing.

  3. Hospitalization

    Time frame: 90-day follow-up

    Need for readmission.

  4. Major Bleeding

    Time frame: 90-day follow-up

    Major bleeding (defined according to previously published criteria)

  5. Clinically Relevant Non Major Bleeding

    Time frame: 90-day follow-up

    Clinically relevant non major bleeding (defined according to previously published criteria)

  6. Serious Adverse Events

    Time frame: 90-day follow-up

    Serious adverse events.

Sponsors and collaborators

Lead sponsor

Ministry of Health, Spain

Other Gov

Collaborators

  • American College of Chest Physicians
  • Sociedad Española de Neumología y Cirugía Torácica

Registry information

Official study 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

Acronym: SLICE

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 12, 2014
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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