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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objectives: To evaluate the safety of outpatient treatment of patients with very low-risk pulmonary embolism (PE), and the satisfaction and quality of life of this management.

Methods: An experimental study of routine clinical practice will be carried out in which 300 consecutive hemodynamically stable patients with acute symptomatic PE will be included, who meet all the inclusion criteria and none of the exclusion criteria. All patients included in the study will be treated on an outpatient basis, that is, they will be discharged within the first 24 hours of the diagnosis of PE in the Emergency Department. The Computerized Registry of Thromboembolic Disease RIETE (Registro Informatizado de Enfermedad TromboEmbólica) will be used to collect the data in electronic case report form (CRF) and ensure the quality of the data. Setting: Emergency, Pneumology and Internal Medicine Services of 10 Spanish hospitals. Analysis: An intention-to-treat (ITT) analysis will be performed on all patients who sign the informed consent and are included in the study (regardless of whether or not they receive the assigned strategy). Additionally, an analysis of all patients who are treated on an outpatient basis without deviations or violations of the protocol will be performed. The primary outcome considered will be the composite of recurrent PE, major bleeding, or death from any cause during the first 30 days after enrollment in the study. Patient satisfaction and quality of life will be considered as secondary outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Clinic
NOT_YET_RECRUITING
Barcelona
Hospital General Universitari de Castelló
NOT_YET_RECRUITING
Castelló
Hospital Universitario Donostia
NOT_YET_RECRUITING
Donostia / San Sebastian
Hospital Universitario Virgen de las Nieves
NOT_YET_RECRUITING
Granada
Hospital San Pedro
NOT_YET_RECRUITING
Logroño
Clínica Universidad Navarra
NOT_YET_RECRUITING
Madrid
Hospital Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Hospital Ramón y Cajal
RECRUITING
Madrid
Complejo Hospitalario Virgen del Rocío
NOT_YET_RECRUITING
Seville
Hospital Doctor Peset
NOT_YET_RECRUITING
Valencia
Contact Information
Primary
PEDRO Ruiz-Artacho, PhD, MD
pruiza@unav.es
636781570
Time Frame
Start Date: 2023-04-10
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 300
Treatments
Experimental: Hemodynamically stable patients with very low risk symptomatic acute pulmonary embolism (PE)
Related Therapeutic Areas
Sponsors
Leads: Clinica Universidad de Navarra, Universidad de Navarra

This content was sourced from clinicaltrials.gov