Open AccessThe 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
Author(s) -
Jiménez David,
Agustí Alvar,
Monreal Manuel,
Otero Remedios,
Huisman Menno V.,
Lobo José L.,
Quezada Andrés,
JaraPalomares Luis,
Hernando Ascensión,
Tabernero Eva,
Marcos Pedro,
RuizArtacho Pedro,
Ballaz Aitor,
Bertoletti Laurent,
Couturaud Francis,
Yusen Roger
Publication year - 2019
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.23161
Subject(s) - medicine , interquartile range , pulmonary embolism , randomized controlled trial , copd , pediatrics , emergency medicine
Some previous studies have suggested a high prevalence of pulmonary embolism (PE) during exacerbations of chronic obstructive pulmonary disease (ECOPD). The SLICE trial aims to assess the efficacy and safety of an active strategy for the diagnosis and treatment of PE (vs usual care) in patients hospitalized because of ECOPD. Methods SLICE is a phase III, prospective, international, multicenter, randomized, open‐label, and parallel‐group trial. A total of 746 patients hospitalized because of ECOPD will be randomized in a 1:1 fashion to receive either an active strategy for the diagnosis and anticoagulant treatment of PE or usual care (ie, standard care without any diagnostic test for diagnosing PE). The primary outcome is a composite of all‐cause death, non‐fatal (recurrent) venous thromboembolism (VTE), or readmission for ECOPD within 90 days after enrollment. Secondary outcomes are (a) death from any cause within 90 days after enrollment, (b) non‐fatal (recurrent) VTE within 90 days after enrollment, (c) readmission within 90 days after enrollment, and (d) length of hospital stay. Results Enrollment started in September 2014 and is expected to proceed until 2020. Median age of the first 443 patients was 71 years (interquartile range, 64‐78), and 26% were female. Conclusions This multicenter trial will determine the value of detecting PEs in patients with ECOPD. This has implications for COPD patient morbidity and mortality. Trial registration number: NCT02238639.