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Clinical Trial Summary

The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04263038
Study type Interventional
Source Insel Gruppe AG, University Hospital Bern
Contact Drahomir Aujesky, Prof. MD MSc
Phone +41 31 632 88 84
Email SAFE-SSPE@insel.ch
Status Recruiting
Phase Phase 4
Start date May 15, 2020
Completion date May 2026

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