Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism (NCT04263038)
Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert, Brussels Capital
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (40 Sites)
Showing the first 25 of 40 sites.
- Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert, Brussels Capital
- Centre hospitalier universitaire de Liege — Liège,
- The Ottawa Hospital — Ottawa,
- Hôpital Bicêtre - APHP — Le Kremlin-Bicêtre, Le Kremlin-Bicêtre
- Centre Hospitalier Regional Et Universitaire De Brest — Brest,
- CHU Gabriel-Montpied — Clermont-Ferrand,
- Centre Hospitalier Universitaire De Dijon — Dijon,
- Hospital Edouard Herriot — Lyon,
- Hôpitaux universitaires de Marseille Timone AP-HM — Marseille,
- CHU De Rouen — Rouen,
- CHU ST Etienne - Hôpital Nord — Saint-Priest-en-Jarez,
- Albert Schweitzer Ziekenhuis Dordrecht — Dordrecht,
- Medisch Spectrum Twente — Enschede,
- Leiden University Medical Center — Leiden,
- Erasmus Universitair Medisch Centrum — Rotterdam,
- Haaglanden Medisch Centrum — The Hague,
- Isala Klinieken Zwolle — Zwolle,
- Cantonal Hospital of Liestal — Liestal, Basel
- Cantonal Hospital of Aarau — Aarau, Canton of Aargau
- University Hospital Inselspital — Bern, Canton of Bern
- Hospital of Bienne — Biel/Bienne, Canton of Bern
- Cantonal Hospital of Fribourg — Fribourg, Canton of Fribourg
- Cantonal Hospital of Lucerne — Lucerne, Canton of Lucerne
- Cantonal Hospital of Olten — Olten, Canton of Solothurn
- Cantonal Hospital of St. Gallen — Sankt Gallen, Canton of St. Gallen
📞 Contact the Study Coordinator
Phone: +41 31 632 88 84
Email: SAFE-SSPE@insel.ch
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.