N/A
Completed N=746
Pulmonary Embolism as a Cause of COPD Exacerbations
Source: ClinicalTrials.gov NCT02238639 ↗Enrolled (actual)
746
Serious AEs
4.9%
Results posted
Nov 2022
Primary outcomePrimary: All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission. — 110; 107 Participants
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.
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 | — |
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. Informational only — not medical advice.