Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental
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
| Condition(s) | Pulmonary Embolism, Embolism, Embolism and Thrombosis, Lung Diseases, Cardiovascular Diseases, Respiratory Tract Diseases, Venous Thromboembolism, Anticoagulant-induced Bleeding, Bleeding |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: 1. Informed Consent as documented by signature 2. Age ≥18 years 3. Objective diagnosis of symptomatic or asymptomatic isolated SSPE Exclusion Criteria: 1. Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above) 2. Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months 3. ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor) 4. Clinical instability (systolic blood pressure \<100 mm Hg or arterial Oxygen saturation \<92% at ambient air) at the time of presentation 5. Active bleeding or at high risk of bleeding 6. Severe renal failure (creatinine clearance \<30ml/min) 7. Severe liver insufficiency (Child-Pugh B or C) 8. Concomitant use |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Drahomir Aujesky |
| Locations | Woluwe-Saint-Lambert, Brussels Capital, Belgium; Liège, Belgium; Ottawa, Canada; Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France; Brest, France; Clermont-Ferrand, France (+34 more sites) |
| Start date | 2020-05-15 |
| NCT ID | NCT04263038 |
| Official listing | https://clinicaltrials.gov/study/NCT04263038 |