Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism.

Launched by CLINICA UNIVERSIDAD DE NAVARRA, UNIVERSIDAD DE NAVARRA · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of treating patients with very low-risk acute pulmonary embolism (PE) as outpatients. This means that instead of staying in the hospital, eligible patients will be sent home within 24 hours of their diagnosis, allowing them to recover in a more comfortable setting. To be eligible, participants must have a confirmed diagnosis of PE through specific imaging tests, show that their heart is functioning normally, and have a low risk of complications, as measured by a special scoring system.

During the trial, researchers will closely monitor around 300 patients for any serious issues, such as recurring PE or major bleeding, within the first month after treatment. They will also gather information on patient satisfaction and quality of life during this time. The study will take place in ten hospitals in Spain, and participants can expect regular follow-ups to ensure their health and safety throughout the process. Overall, this trial aims to provide insights into a potentially safer and more comfortable approach to managing pulmonary embolism for certain patients.

Gender

ALL

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