Pulmonary Embolism as a Cause of COPD Exacerbations (SLICE)

November 5, 2022 updated by: David Jimenez, Ministry of Health, Spain

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

746

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Baracaldo, Spain
        • Hospital Galdakao
      • Barcelona, Spain
        • Clínica Nostra Senyora del Remei
      • Barcelona, Spain
        • Hospital Capio Sagrat Cor
      • Bilbao, Spain
        • Hospital Cruces
      • La Coruña, Spain
        • Hospital La Coruña
      • Logroño, Spain
        • Hospital San Pedro
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Alcorcón
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital La Paz
      • Pontevedra, Spain
        • Complejo Hospitalario Pontevedra
      • Santander, Spain
        • Hospital Marques de Valdecilla
      • Santiago de Compostela, Spain
        • Policlinico La Rosaleda
      • Sevilla, Spain
        • Hospital Virgen del Rocio
      • Vitoria, Spain
        • Hospital Txagorritxu
      • Zaragoza, Spain
        • Hospital Lozano Blesa
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Germans Trias i Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90-day follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Mortality
Time Frame: 90-day follow-up
All-cause mortality.
90-day follow-up
Symptomatic Recurrent Venous Thromboembolism
Time Frame: 90-day follow-up
Symptomatic venous thromboembolic recurrence confirmed by objective testing.
90-day follow-up
Hospitalization
Time Frame: 90-day follow-up
Need for readmission.
90-day follow-up
Major Bleeding
Time Frame: 90-day follow-up
Major bleeding (defined according to previously published criteria)
90-day follow-up
Clinically Relevant Non Major Bleeding
Time Frame: 90-day follow-up
Clinically relevant non major bleeding (defined according to previously published criteria)
90-day follow-up
Serious Adverse Events
Time Frame: 90-day follow-up
Serious adverse events.
90-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Spain

Collaborators

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

Investigators

  • Study Chair: David Jimenez, MD, PhD, IRYCIS, Alcala de Henares University
  • Study Chair: Alvar Agusti, MD, PhD, Hospital Clínic
  • Study Chair: Manuel Monreal, MD, PhD, Germans Trias I Pujol Hospital
  • Study Chair: Remedios Otero, MD, PhD, Hospital Virgen del Rocio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 5, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLICE 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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