Pulmonary Embolism as a Cause of COPD Exacerbations

NCT ID: NCT02238639

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 746 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2020-12-31

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.

Conditions

Pulmonary Embolism; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Standard management

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Chest Physicians

OTHER

Sponsor Role: collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: collaborator

Ministry of Health, Spain

OTHER_GOV

Sponsor Role: lead

Responsible Party

David Jimenez

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Jimenez, MD, PhD

Role: STUDY_CHAIR

IRYCIS, Alcala de Henares University

Alvar Agusti, MD, PhD

Role: STUDY_CHAIR

Hospital Clinic

Manuel Monreal, MD, PhD

Role: STUDY_CHAIR

Germans Trias i Pujol Hospital

Remedios Otero, MD, PhD

Role: STUDY_CHAIR

Hospital Virgen del Rocio

Locations

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital La Coruña

A Coruña, , Spain

Hospital Galdakao

Barakaldo, , Spain

Clinica Nostra Senyora del Remei

Barcelona, , Spain

Hospital Capio Sagrat Cor

Barcelona, , Spain

Hospital Cruces

Bilbao, , Spain

Hospital San Pedro

Logroño, , Spain

Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University

Madrid, , Spain

Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Alcorcon

Madrid, , Spain

Hospital Doce de Octubre

Madrid, , Spain

Hospital Gregorio Marañon

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Complejo Hospitalario Pontevedra

Pontevedra, , Spain

Hospital Marques de Valdecilla

Santander, , Spain

Policlinico La Rosaleda

Santiago de Compostela, , Spain

Hospital Virgen del Rocio

Seville, , Spain

Hospital Txagorritxu

Vitoria-Gasteiz, , Spain

Hospital Lozano Blesa

Zaragoza, , Spain

Countries

Spain

References

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SLICE 1

Identifier Type: -

Identifier Source: org_study_id