An interventional study of Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT). in Pulmonary Embolism and Chronic Obstructive Pulmonary Disease, sponsored by Ministry of Health, Spain. Completed at 19 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-01.
Sponsored by Ministry of Health, Spain · Not applicable, Interventional, and Treatment
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 746 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Ministry of Health, Spain is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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).
All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician.
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.
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.
Time frame: 90-day follow-up
All-cause Mortality
All-cause mortality.
Time frame: 90-day follow-up
Symptomatic Recurrent Venous Thromboembolism
Symptomatic venous thromboembolic recurrence confirmed by objective testing.
Time frame: 90-day follow-up
Hospitalization
Need for readmission.
Time frame: 90-day follow-up
Major Bleeding
Major bleeding (defined according to previously published criteria)
Time frame: 90-day follow-up
Clinically Relevant Non Major Bleeding
Clinically relevant non major bleeding (defined according to previously published criteria)
Time frame: 90-day follow-up
Serious Adverse Events
Serious adverse events.
Time frame: 90-day follow-up
| Milestone | Active Search for Pulmonary Embolism | Standard Management |
|---|---|---|
| Started | 374 | 372 |
| Completed | 370 | 367 |
| Not completed | 4 | 5 |
Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.
| Participants | Active Search for Pulmonary Embolism | Standard Management |
|---|---|---|
| All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission. | 110 | 107 |
All-cause mortality.
| participants | Active Search for Pulmonary Embolism | Standard Management |
|---|---|---|
| All-cause Mortality | 23 | 29 |
Symptomatic venous thromboembolic recurrence confirmed by objective testing.
| participants | Active Search for Pulmonary Embolism | Standard Management |
|---|---|---|
| Symptomatic Recurrent Venous Thromboembolism | 2 | 9 |
Need for readmission.
| participants | Active Search for Pulmonary Embolism | Standard Management |
|---|---|---|
| Hospitalization | 94 | 84 |
Major bleeding (defined according to previously published criteria)
| participants | Active Search for Pulmonary Embolism | Standard Management |
|---|---|---|
| Major Bleeding | 3 | 3 |
Clinically relevant non major bleeding (defined according to previously published criteria)
| participants | Active Search for Pulmonary Embolism | Standard Management |
|---|---|---|
| Clinically Relevant Non Major Bleeding | 1 | 1 |
Serious adverse events.
| participants | Active Search for Pulmonary Embolism | Standard Management |
|---|---|---|
| Serious Adverse Events | 18 | 18 |
Collected over 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Search for Pulmonary Embolism | 23/370 (6.2%) | 18/370 (4.9%) | 0/370 (0%) |
| Standard Management | 29/367 (7.9%) | 18/367 (4.9%) | 0/367 (0%) |
| Event | Active Search for Pulmonary Embolism | Standard Management |
|---|---|---|
| SAEsInvestigations | 18/370 | 18/367 |
| Age, Continuous(years) | Active Search for Pulmonary Embolism | Standard Management | Total |
|---|---|---|---|
| Mean | 70.2 ± 9.9 | 70.6 ± 9.9 | 70.3 ± 9.9 |
| Sex: Female, Male(Participants) | Active Search for Pulmonary Embolism | Standard Management | Total |
|---|---|---|---|
| Female | 86 | 109 | 195 |
| Male | 284 | 258 | 542 |
| Race (NIH/OMB)(Participants) | Active Search for Pulmonary Embolism | Standard Management | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 370 | 367 | 737 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Active Search for Pulmonary Embolism | Standard Management | Total |
|---|---|---|---|
| Spain | 370 | 367 | 737 |
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Ministry of Health, Spain