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

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.

Conditions

• Acute Pulmonary Embolism
• Outpatient Treatment

Interventions

OTHER

Outpatient treatment with standard anticoagulant therapy

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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• PEDRO Ruiz-Artacho, PhD, MD · Clínica Universidad de Navarra, Madrid (España)

• Raquel Morillo Guerrero, PhD, MD · Hospital Ramón y Cajal, Madrid (España)

• DAVID Jiménez Castro, PhD, MD · Hospital Ramón y Cajal, Madrid (España)

• Deisy Barrios Barreto, PhD, MD · Hospital Ramón y Cajal, Madrid (España)

• Pablo Demelo Rodríguez, PhD, MD · Hospital Universitario Gregorio Marañón, Madrid (España)

• Alberto García-Ortega, PhD, MD · Hospital Doctor Peset, Valencia (España)

• Andrea Pérez Figuera, MD · Hospital Ramón y Cajal, Madrid (España)

• Elena Hernando López, MD · Hospital San Pedro, Logroño (España)

• Luis Jara Palomares, PhD, MD · Complejo Hospitalario Virgen del Rocío, Sevilla (España)

• Jorge Moisés Lafuente, MD · Hospital Clinic (España)

• Ignacio Casado Moreno, MD · Hospital Universitario Virgen de las Nieves, Granada (España

• Tina Rivas, MD · Hospital Universitario Donostia (España)

• Daniel Segura Ayala, MD · Hospital General Universitari de Castelló (España)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-10

Primary Completion

2025-12-31

Completion

2026-02-28

Countries

• Spain

Study Locations