Outpatient treatment for low-risk pulmonary embolism patients
Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism. TRAMTEP Study.
This study is testing if outpatient treatment is safe and improves the quality of life for patients with low-risk pulmonary embolism who can go home within a day of diagnosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra Academic / other |
| Locations | 10 sites (Barcelona and 9 other locations) |
| Trial ID | NCT05852119 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and quality of life for patients with very low-risk acute symptomatic pulmonary embolism (PE) who receive outpatient treatment. It involves 300 hemodynamically stable patients who will be discharged within 24 hours of diagnosis and treated with standard anticoagulant therapy. Data will be collected using the Computerized Registry of Thromboembolic Disease (RIETE) to ensure quality and facilitate analysis. The study will be conducted across 10 hospitals in Spain.
Who should consider this trial
Good fit: Ideal candidates are hemodynamically stable patients diagnosed with very low-risk acute symptomatic pulmonary embolism.
Not a fit: Patients who are hemodynamically unstable or have contraindications for anticoagulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow low-risk PE patients to be treated safely at home, improving their quality of life and reducing hospital stays.
How similar studies have performed: Other studies have shown promise in outpatient management of low-risk pulmonary embolism, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmation of suspected pulmonary embolism (PE) by multidetector chest angio computed tomography (CT), if a contrast-encircled partial intraluminal defect or complete pulmonary artery occlusion is demonstrated on two consecutive CT slices (13); * Right ventricle (RV) diameter equal to or less than that of the left ventricle (LV) (RV/LV ratio ≤1) on chest CT angiography (see Study Procedures); and * Negatively modified simplified Pulmonary Embolism Severity Index (sPESI) scale at the time of evaluation of the patient in the Emergency Department. Exclusion Criteria: * Inability to obtain informed consent * Pregnancy * Hemodynamic instability at diagnosis (defined by systolic blood pressure (SBP) \<90 mm Hg, indication of fibrinolytic treatment or inferior vena cava filter, need for vasoactive drugs at the discretion of the attending physician, cardiopulmonary resuscitation or orotracheal intubation) * Contraindication for anticoagulation, at the discretion of the responsible physician; * Estimated survival of less than 3 months * Need for thrombectomy, vena cava filter insertion, or need for fibrinolytic treatment of the PE episode at the time of diagnosis * Participation in a clinical trial for the treatment of venous thromboembolic disease * Impossibility of follow up
Where this trial is running
Barcelona and 9 other locations
- Hospital Clinic — Barcelona, Spain (Not_yet_recruiting)
- Hospital General Universitari de Castelló — Castelló, Spain (Not_yet_recruiting)
- Hospital Universitario Donostia — Donostia, Spain (Not_yet_recruiting)
- Hospital Universitario Virgen de las Nieves — Granada, Spain (Not_yet_recruiting)
- Hospital San Pedro — Logroño, Spain (Not_yet_recruiting)
- Clínica Universidad Navarra — Madrid, Spain (Not_yet_recruiting)
- Hospital Gregorio Marañón — Madrid, Spain (Not_yet_recruiting)
- Hospital Ramón y Cajal — Madrid, Spain (Recruiting)
- Complejo Hospitalario Virgen del Rocío — Sevilla, Spain (Not_yet_recruiting)
- Hospital Doctor Peset — Valencia, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Pablo Demelo Rodríguez, PhD, MD — Hospital Universitario Gregorio Marañón, Madrid (España)
- Study coordinator: PEDRO Ruiz-Artacho, PhD, MD
- Email: pruiza@unav.es
- Phone: 636781570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.