SLICE: Pulmonary Embolism as a Cause of COPD Exacerbations

Sponsor

Ministry of Health, Spain (Other)

Overall Status

Completed

CT.gov ID

NCT02238639

Collaborator

American College of Chest Physicians (Other), Sociedad Española de Neumología y Cirugía Torácica (Other)

746

Enrollment

Locations

Arms

Actual Duration (Months)

39.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism Chronic Obstructive Pulmonary Disease	Procedure: Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

746 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active search for pulmonary embolism All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.	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.
No Intervention: Standard management All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.

Arm

Intervention/Treatment

Experimental: Active search for pulmonary embolism

All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed.

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.

No Intervention: Standard management

All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.

Outcome Measures

Primary Outcome Measures

All-cause mortality, symptomatic venous thromboembolism recurrence, or need for readmission. [90-day follow-up]
Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.

Secondary Outcome Measures

All-cause mortality [90-day follow-up]
All-cause mortality.
Symptomatic recurrent venous thromboembolism [90-day follow-up]
Symptomatic venous thromboembolic recurrence confirmed by objective testing.
Hospitalization [90-day follow-up]
Need for readmission.
Major bleeding [90-day follow-up]
Major bleeding (defined according to previously published criteria)
Clinically relevant non major bleeding [90-day follow-up]
Clinically relevant non major bleeding (defined according to previously published criteria)
Serious adverse events [90-day follow-up]
Serious adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain
2	Hospital Galdakao	Baracaldo		Spain
3	Clinica Nostra Senyora del Remei	Barcelona		Spain
4	Hospital Capio Sagrat Cor	Barcelona		Spain
5	Hospital Cruces	Bilbao		Spain
6	Hospital La Coruña	La Coruña		Spain
7	Hospital San Pedro	Logroño		Spain
8	Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University	Madrid		Spain	28034
9	Fundacion Jimenez Diaz	Madrid		Spain
10	Hospital Alcorcon	Madrid		Spain
11	Hospital Doce de Octubre	Madrid		Spain
12	Hospital Gregorio Marañon	Madrid		Spain
13	Hospital La Paz	Madrid		Spain
14	Complejo Hospitalario Pontevedra	Pontevedra		Spain
15	Hospital Marques de Valdecilla	Santander		Spain
16	Policlinico La Rosaleda	Santiago de Compostela		Spain
17	Hospital Virgen del Rocio	Sevilla		Spain
18	Hospital Txagorritxu	Vitoria		Spain
19	Hospital Lozano Blesa	Zaragoza		Spain