Condition: Pulmonary Embolism · Embolism · Embolism and Thrombosis · Sponsor: Drahomir Aujesky
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.
This description comes directly from the study's public registry record.
Drahomir Aujesky, Prof. MD MSc · +41 31 632 88 84 · SAFE-SSPE@insel.ch
Tobias Tritschler, Dr. MD MSc · +41 31 63 2 01 46 · SAFE-SSPE@insel.ch
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| Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert, Brussels Capital, Belgium | Recruiting |
| Centre hospitalier universitaire de Liege | Liège, Belgium | Recruiting |
| The Ottawa Hospital | Ottawa, Canada | Recruiting |
| Hôpital Bicêtre - APHP | Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France | Recruiting |
| Centre Hospitalier Regional Et Universitaire De Brest | Brest, France | Recruiting |
| CHU Gabriel-Montpied | Clermont-Ferrand, France | Recruiting |
| Centre Hospitalier Universitaire De Dijon | Dijon, France | Recruiting |
| Hospital Edouard Herriot | Lyon, France | Recruiting |
| Hôpitaux universitaires de Marseille Timone AP-HM | Marseille, France | Recruiting |
| CHU De Rouen | Rouen, France | Recruiting |
| CHU ST Etienne - Hôpital Nord | Saint-Priest-en-Jarez, France | Recruiting |
| Albert Schweitzer Ziekenhuis Dordrecht | Dordrecht, Netherlands | Recruiting |
+ 28 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04263038