An observational study in Pulmonary Embolism, sponsored by Franciscus Gasthuis. Recruiting at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Franciscus Gasthuis · Observational
Introduction:
The diagnosis of pulmonary embolism (PE) is a challenge in the Emergency Department. D-dimer based diagnostic algorithms for PE have a very high sensitivity, but rely upon a vast amount of CT angiography and potentially unnecessary exposure to radiation. An accurate diagnostic algorithm that does not involve d-dimer testing might reduce this burden.
An abnormal Alveolar-arterial oxygen gradient (A-a gradient) seems to increase the chance of PE. However, a normal A-a gradient on its own does not exclude the diagnosis. In this paper, the accuracy of A-a gradient testing and a combination of Years criteria with A-a gradient testing will be assessed.
Methods:
This is a prospective, single center, observational study. All patients that present at our emergency department from September 2022 until September 2023 with a suspicion of pulmonary embolism will be analyzed for eligibility and included in the study after informed consent. The aim is to include at least 230 patients in the study.
Analysis: The primary outcome is the diagnostic accuracy of a YEARS and A-a gradient based algorithm for pulmonary embolism. The secondary outcome is the potential decrease in performed imaging in order to exclude pulmonary embolism.
Valorisation An accurate A-a gradient-based algorithm for pulmonary embolism in low risk patients will be a step towards an improved clinical risk score. We aim to reduce the amount of diagnostic imaging, i.e. CT-angiography. Meaning less, potentially unnecessary, exposure to radiation for the patient. Furthermore, it could lower healthcare costs by reducing expensive diagnostic imaging.
739 studies on the registry are indexed under Pulmonary Embolism; 158 are open to participants now.
This study's planned enrollment of 230 is below the median of 383 across 323 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Franciscus Gasthuis is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients that present in our emergency department with suspicion of pulmonary embolism
Exclusion Criteria:
Patients with suspected pulmonary embolism
Diagnostic Test: Laboratory testing: D-dimeer and astrup
Standard care: Laboratory result (D-dimer and astrup). CT scan for pulmonary embolism if indicated
Also known as: CT-scan for pulmonary embolism
Diagnostic accuracy of a combination of a normal Alveolar-Arterial Oxygen Gradient with negative YEARS criteria in patients with suspected pumonary embolism
Time frame: At submission in the Emergency Department
How many CT-scans would have been avoided if the algorithm was used in normal practice
Time frame: At submission in the Emergency Department
Plan to share: No
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Franciscus Gasthuis