N/A
N=746
Pulmonary Embolism as a Cause of COPD Exacerbations
Pulmonary Embolism · Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT02238639 ↗Enrolled (actual)
746
Serious AEs
4.9%
Results posted
Nov 2022
Primary outcome: Primary: All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission. — 110; 107 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT). (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ministry of Health, Spain
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission. |
110; 107 | — |
| SECONDARY All-cause Mortality |
23; 29 | — |
| SECONDARY Symptomatic Recurrent Venous Thromboembolism |
2; 9 | — |
| SECONDARY Hospitalization |
94; 84 | — |
| SECONDARY Major Bleeding |
3; 3 | — |
| SECONDARY Clinically Relevant Non Major Bleeding |
1; 1 | — |
| SECONDARY Serious Adverse Events |
18; 18 | — |
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) 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.
Data sourced from ClinicalTrials.gov (NCT02238639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.