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Pulmonary Embolism as a Cause of COPD Exacerbations (SLICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02238639
Recruitment Status : Completed
First Posted : September 12, 2014
Results First Posted : November 7, 2022
Last Update Posted : December 1, 2022
Sponsor:
Collaborators:
American College of Chest Physicians
Sociedad Española de Neumología y Cirugía Torácica
Information provided by (Responsible Party):
David Jimenez, Ministry of Health, Spain

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 746 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Ministry of Health, Spain
American College of Chest Physicians
Sociedad Española de Neumología y Cirugía Torácica
Investigators
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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
  Study Documents (Full-Text)

Documents provided by David Jimenez, Ministry of Health, Spain:
Study Protocol  [PDF] September 3, 2018
Statistical Analysis Plan  [PDF] September 3, 2018

More Information
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Publications:
Camargo CA Jr, Roberts J, Clark S. US emergency department visits for COPD exacerbations between 1992 and 1998. Am J Epidemiol 2001; 153: S80.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: David Jimenez, Senior Consultant, Ministry of Health, Spain
ClinicalTrials.gov Identifier: NCT02238639    
Other Study ID Numbers: SLICE 1
First Posted: September 12, 2014    Key Record Dates
Results First Posted: November 7, 2022
Last Update Posted: December 1, 2022
Last Verified: November 2022
Keywords provided by David Jimenez, Ministry of Health, Spain:
Venous thromboembolism
COPD exacerbations
Anticoagulation
Mortality
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Embolism
Embolism
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants