Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism
Status:
Recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Drahomir Aujesky University Hospital Inselspital, Berne
Collaborators:
Bayer Leiden University Medical Center Schweizerischer Nationalfonds The Ottawa Hospital University of Bern