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Pulmonary Embolism as a Cause of COPD Exacerbations (SLICE)

Primary Purpose

Pulmonary Embolism, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).
Sponsored by
Ministry of Health, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Venous thromboembolism, COPD exacerbations, Anticoagulation, Mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Germans Trias i Pujol
  • Hospital Galdakao
  • Clinica Nostra Senyora del Remei
  • Hospital Capio Sagrat Cor
  • Hospital Cruces
  • Hospital La Coruña
  • Hospital San Pedro
  • Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University
  • Fundacion Jimenez Diaz
  • Hospital Alcorcon
  • Hospital Doce de Octubre
  • Hospital Gregorio Marañon
  • Hospital La Paz
  • Complejo Hospitalario Pontevedra
  • Hospital Marques de Valdecilla
  • Policlinico La Rosaleda
  • Hospital Virgen del Rocio
  • Hospital Txagorritxu
  • Hospital Lozano Blesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active search for pulmonary embolism

Standard management

Arm Description

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.

All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.

Outcomes

Primary Outcome Measures

All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2014
Last Updated
November 5, 2022
Sponsor
Ministry of Health, Spain
Collaborators
American College of Chest Physicians, Sociedad Española de Neumología y Cirugía Torácica
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1. Study Identification

Unique Protocol Identification Number
NCT02238639
Brief Title
Pulmonary Embolism as a Cause of COPD Exacerbations
Acronym
SLICE
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Spain
Collaborators
American College of Chest Physicians, Sociedad Española de Neumología y Cirugía Torácica

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Chronic Obstructive Pulmonary Disease
Keywords
Venous thromboembolism, COPD exacerbations, Anticoagulation, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active search for pulmonary embolism
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard management
Arm Type
No Intervention
Arm Description
All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
Intervention Type
Procedure
Intervention Name(s)
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).
Intervention Description
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 Outcome Measure Information:
Title
All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
Description
Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.
Time Frame
90-day follow-up
Secondary Outcome Measure Information:
Title
All-cause Mortality
Description
All-cause mortality.
Time Frame
90-day follow-up
Title
Symptomatic Recurrent Venous Thromboembolism
Description
Symptomatic venous thromboembolic recurrence confirmed by objective testing.
Time Frame
90-day follow-up
Title
Hospitalization
Description
Need for readmission.
Time Frame
90-day follow-up
Title
Major Bleeding
Description
Major bleeding (defined according to previously published criteria)
Time Frame
90-day follow-up
Title
Clinically Relevant Non Major Bleeding
Description
Clinically relevant non major bleeding (defined according to previously published criteria)
Time Frame
90-day follow-up
Title
Serious Adverse Events
Description
Serious adverse events.
Time Frame
90-day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Jimenez, MD, PhD
Organizational Affiliation
IRYCIS, Alcala de Henares University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alvar Agusti, MD, PhD
Organizational Affiliation
Hospital Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Manuel Monreal, MD, PhD
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Remedios Otero, MD, PhD
Organizational Affiliation
Hospital Virgen del Rocio
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Galdakao
City
Baracaldo
Country
Spain
Facility Name
Clinica Nostra Senyora del Remei
City
Barcelona
Country
Spain
Facility Name
Hospital Capio Sagrat Cor
City
Barcelona
Country
Spain
Facility Name
Hospital Cruces
City
Bilbao
Country
Spain
Facility Name
Hospital La Coruña
City
La Coruña
Country
Spain
Facility Name
Hospital San Pedro
City
Logroño
Country
Spain
Facility Name
Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
Hospital Alcorcon
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Complejo Hospitalario Pontevedra
City
Pontevedra
Country
Spain
Facility Name
Hospital Marques de Valdecilla
City
Santander
Country
Spain
Facility Name
Policlinico La Rosaleda
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
Country
Spain
Facility Name
Hospital Lozano Blesa
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

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Pulmonary Embolism as a Cause of COPD Exacerbations

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