Pulmonary Embolism as a Cause of COPD Exacerbations

Chronic Obstructive Pulmonary Disease Clinical Trial

— SLICE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238639
• Other study ID #: SLICE 1
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2020

Study information

• Verified date: November 2022
• Source: Ministry of Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Embolism
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Embolism

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Galdakao	Baracaldo
Spain	Clinica Nostra Senyora del Remei	Barcelona
Spain	Hospital Capio Sagrat Cor	Barcelona
Spain	Hospital Cruces	Bilbao
Spain	Hospital La Coruña	La Coruña
Spain	Hospital San Pedro	Logroño
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	Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University	Madrid
Spain	Complejo Hospitalario Pontevedra	Pontevedra
Spain	Hospital Marques de Valdecilla	Santander
Spain	Policlinico La Rosaleda	Santiago de Compostela
Spain	Hospital Virgen del Rocio	Sevilla
Spain	Hospital Txagorritxu	Vitoria
Spain	Hospital Lozano Blesa	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Ministry of Health, Spain	American College of Chest Physicians, Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Anderson DR, Kahn SR, Rodger MA, Kovacs MJ, Morris T, Hirsch A, Lang E, Stiell I, Kovacs G, Dreyer J, Dennie C, Cartier Y, Barnes D, Burton E, Pleasance S, Skedgel C, O'Rouke K, Wells PS. Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: a randomized controlled trial. JAMA. 2007 Dec 19;298(23):2743-53. doi: 10.1001/jama.298.23.2743. — View Citation

Camargo CA Jr, Roberts J, Clark S. US emergency department visits for COPD exacerbations between 1992 and 1998. Am J Epidemiol 2001; 153: S80.

Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S-e496S. doi: 10.1378/chest.11-2301. Erratum In: Chest. 2012 Dec;142(6):1698-1704. — View Citation

Peces-Barba G, Barbera JA, Agusti A, Casanova C, Casas A, Izquierdo JL, Jardim J, Lopez Varela V, Monso E, Montemayor T, Viejo JL. [Diagnosis and management of chronic obstructive pulmonary disease: joint guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Latin American Thoracic Society (ALAT)]. Arch Bronconeumol. 2008 May;44(5):271-81. No abstract available. Spanish. — View Citation

Poulsen SH, Noer I, Moller JE, Knudsen TE, Frandsen JL. Clinical outcome of patients with suspected pulmonary embolism. A follow-up study of 588 consecutive patients. J Intern Med. 2001 Aug;250(2):137-43. doi: 10.1046/j.1365-2796.2001.00866.x. — View 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. — View 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. — View Citation

Rizkallah J, Man SFP, Sin DD. Prevalence of pulmonary embolism in acute exacerbations of COPD: a systematic review and metaanalysis. Chest. 2009 Mar;135(3):786-793. doi: 10.1378/chest.08-1516. Epub 2008 Sep 23. — View Citation

Tillie-Leblond I, Marquette CH, Perez T, Scherpereel A, Zanetti C, Tonnel AB, Remy-Jardin M. Pulmonary embolism in patients with unexplained exacerbation of chronic obstructive pulmonary disease: prevalence and risk factors. Ann Intern Med. 2006 Mar 21;144(6):390-6. doi: 10.7326/0003-4819-144-6-200603210-00005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.	Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.	90-day follow-up
Secondary	All-cause Mortality	All-cause mortality.	90-day follow-up
Secondary	Symptomatic Recurrent Venous Thromboembolism	Symptomatic venous thromboembolic recurrence confirmed by objective testing.	90-day follow-up
Secondary	Hospitalization	Need for readmission.	90-day follow-up
Secondary	Major Bleeding	Major bleeding (defined according to previously published criteria)	90-day follow-up
Secondary	Clinically Relevant Non Major Bleeding	Clinically relevant non major bleeding (defined according to previously published criteria)	90-day follow-up
Secondary	Serious Adverse Events	Serious adverse events.	90-day follow-up