Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism. (TRAMTEP)
Acute Pulmonary Embolism, Outpatient Treatment
About this trial
This is an interventional treatment trial for Acute Pulmonary Embolism
Eligibility 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
Sites / Locations
- Hospital Clinic
- Hospital General Universitari de Castelló
- Hospital Universitario Donostia
- Hospital Universitario Virgen de las Nieves
- Hospital San Pedro
- Clínica Universidad Navarra
- Hospital Gregorio Marañón
- Hospital Ramón y CajalRecruiting
- Complejo Hospitalario Virgen del Rocío
- Hospital Doctor Peset
Arms of the Study
Arm 1
Experimental
Hemodynamically stable patients with very low risk symptomatic acute pulmonary embolism (PE)