Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

Launched by DRAHOMIR AUJESKY · Feb 6, 2020

Keywords

ClinConnect Summary

**Summary of the SAFE-SSPE Clinical Trial**

The SAFE-SSPE trial is investigating whether low-risk patients with a specific type of blood clot in the lungs, known as isolated subsegmental pulmonary embolism (SSPE), can safely avoid treatment with blood thinners (anticoagulants). Traditionally, many patients receive anticoagulants because of concerns about blood clots, even though some studies suggest that not all patients with isolated SSPE need this treatment. By comparing the outcomes of patients who are monitored without anticoagulation to those who receive anticoagulants, the trial aims to determine the best approach for treating these patients while minimizing the risk of bleeding caused by the medication.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of isolated SSPE, whether they have symptoms or not. However, certain individuals will not be able to participate, such as those with active cancer, other types of blood clots, or certain health conditions. If you are eligible and choose to participate, you will receive close monitoring to see how you do without anticoagulants, helping researchers understand if this approach is safe and effective. This trial is currently recruiting participants, so if you or a loved one are interested, it’s a good idea to discuss it with your healthcare provider for more information.

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Eligibility criteria

• 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 of strong CYP3A4 inhibitors or strong CYP3A4 inducers
• • 9. Known hypersensitivity to rivaroxaban
• • 10. Need for therapeutic anticoagulation for another reason
• • 11. Therapeutic anticoagulation for \>72 hours for any reason at the time of screening
• • 12. Hospitalized for \>72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)
• • 13. Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)
• • 14. Lack of safe contraception in women of childbearing potential
• • 15. Refusal or inability to provide informed consent
• • 16. Prior enrolment in this trial