Clinical trial NCT02238639: Pulmonary Embolism as a Cause of COPD Exacerbations
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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Chronic Obstructive Pulmonary Disease
Keywords: Venous thromboembolism
COPD exacerbations
Anticoagulation
Mortality
Lead sponsor: Ministry of Health, Spain
Sponsor class: OTHER_GOV
Collaborators: name: American College of Chest Physicians
name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2014-09-12
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
timeFrame: 90-day follow-up
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 90-day follow-up
measure: Symptomatic Recurrent Venous Thromboembolism
timeFrame: 90-day follow-up
measure: Hospitalization
timeFrame: 90-day follow-up
measure: Major Bleeding
timeFrame: 90-day follow-up
measure: Clinically Relevant Non Major Bleeding
timeFrame: 90-day follow-up
measure: Serious Adverse Events
timeFrame: 90-day follow-up
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Baracaldo
country: Spain
facility: Hospital Galdakao
city: Barcelona
country: Spain
facility: Clinica Nostra Senyora del Remei
city: Barcelona
country: Spain
facility: Hospital Capio Sagrat Cor
city: Bilbao
country: Spain
facility: Hospital Cruces
city: La Coruña
country: Spain
facility: Hospital La Coruña
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Alcorcon
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital La Paz
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Pontevedra
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Policlinico La Rosaleda
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: Zaragoza
country: Spain
facility: Hospital Lozano Blesa
Study officials:
affiliation: IRYCIS, Alcala de Henares University
name: David Jimenez, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Clinic
name: Alvar Agusti, MD, PhD
role: STUDY_CHAIR
affiliation: Germans Trias i Pujol Hospital
name: Manuel Monreal, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Virgen del Rocio
name: Remedios Otero, MD, PhD
role: STUDY_CHAIR
References:
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citation: Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
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citation: Pozo-Rodriguez F, Lopez-Campos JL, Alvarez-Martinez CJ, Castro-Acosta A, Aguero R, Hueto J, Hernandez-Hernandez J, Barron M, Abraira V, Forte A, Sanchez Nieto JM, Lopez-Gabaldon E, Cosio BG, Agusti A; AUDIPOC Study Group. Clinical audit of COPD patients requiring hospital admissions in Spain: AUDIPOC study. PLoS One. 2012;7(7):e42156. doi: 10.1371/journal.pone.0042156. Epub 2012 Jul 31.
citation: Rodriguez C, Jara-Palomares L, Tabernero E, Tenes A, Gonzalez S, Briceno W, Lobo JL, Morillo R, Bikdeli B, Jimenez D. Adjusted D-dimer cutoff levels to rule out pulmonary embolism in patients hospitalized for COPD exacerbation: results from the SLICE trial. Thromb J. 2022 Mar 3;20(1):10. doi: 10.1186/s12959-022-00368-0.
citation: Jimenez D, Agusti A, Tabernero E, Jara-Palomares L, Hernando A, Ruiz-Artacho P, Perez-Penate G, Rivas-Guerrero A, Rodriguez-Nieto MJ, Ballaz A, Aguero R, Jimenez S, Calle-Rubio M, Lopez-Reyes R, Marcos-Rodriguez P, Barrios D, Rodriguez C, Muriel A, Bertoletti L, Couturaud F, Huisman M, Lobo JL, Yusen RD, Bikdeli B, Monreal M, Otero R; SLICE Trial Group. Effect of a Pulmonary Embolism Diagnostic Strategy on Clinical Outcomes in Patients Hospitalized for COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2021 Oct 5;326(13):1277-1285. doi: 10.1001/jama.2021.14846.
citation: Jimenez D, Agusti A, Monreal M, Otero R, Huisman MV, Lobo JL, Quezada A, Jara-Palomares L, Hernando A, Tabernero E, Marcos P, Ruiz-Artacho P, Ballaz A, Bertoletti L, Couturaud F, Yusen R; SLICE investigators. The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy and safety of an active strategy for the diagnosis and treatment of acute pulmonary embolism during exacerbations of chronic obstructive pulmonary disease. Clin Cardiol. 2019 Mar;42(3):346-351. doi: 10.1002/clc.23161. Epub 2019 Feb 25.