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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
276
Anticoagulation
Study drug without active agent
Centre hospitalier universitaire de Liege
Liège, Belgium
NOT_YET_RECRUITINGCliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
RECRUITINGThe Ottawa Hospital
Ottawa, Canada
RECRUITINGHôpital Bicêtre - APHP
Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France
Recurrent venous thromboembolism
Proportion of recurrent, clinically symptomatic, objectively confirmed venous thromboembolism (defined as recurrent fatal or nonfatal pulmonary embolism or lower limb deep vein thrombosis)
Time frame: Within 90 days of randomization
Clinically significant bleeding
Proportion of the composite of major and clinically relevant non-major bleeding
Time frame: Within 90 days of randomization
All-cause mortality
Proportion of deaths (all causes of death will be considered)
Time frame: Within 90 days of randomization
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Centre Hospitalier Regional Et Universitaire De Brest
Brest, France
RECRUITINGCHU Gabriel-Montpied
Clermont-Ferrand, France
RECRUITINGCentre Hospitalier Universitaire De Dijon
Dijon, France
RECRUITINGHospital Edouard Herriot
Lyon, France
RECRUITINGCHU De Rouen
Rouen, France
RECRUITINGCHU ST Etienne - Hôpital Nord
Saint-Priest-en-Jarez, France
RECRUITING...and 29 more locations