Pulmonary Embolism as a Cause of COPD Exacerbations

Conditions

Chronic Obstructive Pulmonary Disease, Pulmonary Embolism

Keywords

Venous thromboembolism, COPD exacerbations, Anticoagulation, Mortality

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.

Najarro M, Briceño W, Rodríguez C, Muriel A, González S, Castillo A, Jara I, Rali P, Toma C, Bikdeli B, Jiménez D.

2023-11-1910 citations

10.1016/j.thromres.2023.11.011

National Early Warning Score-2 for Identification of Patients with Intermediate-High-Risk Pulmonary Embolism.

Rodríguez C, Muriel A, Carrasco L, González S, Briceño W, Durán D, Retegui A, Yusen RD, Bikdeli B, Jiménez D.

2023-06-162 citations

10.1055/s-0043-1769938

Comparison of various prognostic scores for identification of patients with intermediate-high risk pulmonary embolism.

Mirambeaux R, Rodríguez C, Muriel A, González S, Briceño W, Durán D, Retegui A, Otero R, Bikdeli B, Jiménez D.

2023-01-238 citations

10.1016/j.thromres.2023.01.019

Adjusted D-dimer cutoff levels to rule out pulmonary embolism in patients hospitalized for COPD exacerbation: results from the SLICE trial

Carmen Rodríguez, Luis Jara‐Palomares, Eva Tabernero, Andrés Tenes, Sara González et al. (10 authors)

Thrombosis Journal2022-03-035 citations

10.1186/s12959-022-00368-0

Effect of a Pulmonary Embolism Diagnostic Strategy on Clinical Outcomes in Patients Hospitalized for COPD Exacerbation

David Jiménez, Àlvar Agustí, Eva Tabernero, Luis Jara‐Palomares, Ascensión Hernando et al. (43 authors)

JAMA2021-10-0553 citations

10.1001/jama.2021.14846

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

David Jiménez, Àlvar Agustí, Manuel Monréal, Remedios Otero, Menno V. Huisman et al. (17 authors)

Clinical Cardiology2019-02-0111 citations

10.1002/clc.23161

Interventions

PROCEDUREDiagnostic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Symptomatic Recurrent Venous Thromboembolism	90-day follow-up	Symptomatic venous thromboembolic recurrence confirmed by objective testing.
Hospitalization	90-day follow-up	Need for readmission.
All-cause Mortality	90-day follow-up	All-cause mortality.
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.
Major Bleeding	90-day follow-up	Major bleeding (defined according to previously published criteria)

Countries

Spain

Participant flow

Participants by arm

Arm	Count
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. 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.	370
Standard Management All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.	367
Total	737

Baseline characteristics

Characteristic	Active Search for Pulmonary Embolism	Total	Standard Management
Age, Continuous	70.2 years STANDARD_DEVIATION 9.9	70.3 years STANDARD_DEVIATION 9.9	70.6 years STANDARD_DEVIATION 9.9
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	370 Participants	737 Participants	367 Participants
Region of Enrollment Spain	370 participants	737 participants	367 participants
Sex: Female, Male Female	86 Participants	195 Participants	109 Participants
Sex: Female, Male Male	284 Participants	542 Participants	258 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	23 / 370	29 / 367
other Total, other adverse events	0 / 370	0 / 367
serious Total, serious adverse events	18 / 370	18 / 367

Arm	Measure	Value (NUMBER)
Active Search for Pulmonary Embolism	Symptomatic Recurrent Venous Thromboembolism	2 participants
Standard Management	Symptomatic Recurrent Venous Thromboembolism	9 participants

Pulmonary Embolism as a Cause of COPD Exacerbations

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.

All-cause Mortality

Clinically Relevant Non Major Bleeding

Hospitalization

Major Bleeding

Serious Adverse Events

Symptomatic Recurrent Venous Thromboembolism