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Pulmonary Embolism as a Cause of COPD Exacerbations

NCT02238639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2022-12-01

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • American College of Chest Physicians

    collaborator OTHER

  • Sociedad Española de Neumología y Cirugía Torácica

    collaborator OTHER

  • Ministry of Health, Spain

    lead OTHER_GOV

Principal Investigators

  • Manuel Monreal, MD, PhD · Germans Trias i Pujol Hospital

  • Remedios Otero, MD, PhD · Hospital Virgen del Rocio

  • David Jimenez, MD, PhD · IRYCIS, Alcala de Henares University

  • Alvar Agusti, MD, PhD · Hospital Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-10-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02238639 on ClinicalTrials.gov