NCT02238639

Pulmonary Embolism as a Cause of COPD Exacerbations

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 746 (actual)
• Sponsor: Ministry of Health, Spain · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2014-09-12
• Last updated: 2022-12-01
• Results posted: 2022-11-07

Locations

19 sites across 1 country: Spain