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

NCT05852119 | Recruiting DMC

• 1 other identifier: 295-22
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief 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

Outcome Measures

Primary Outcomes (1)

• Composite of recurrent pulmonary embolism (PE), major bleeding, or death from any cause.

  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.

  30 days

Secondary Outcomes (2)

• Satisfaction of the patients

  30 days

• Quality of life of the patients

  30 days

Study Arms (1)

Hemodynamically stable patients with very low risk symptomatic acute pulmonary embolism (PE)

EXPERIMENTAL

Other: Outpatient treatment with standard anticoagulant therapy

Interventions

Outpatient treatment with standard anticoagulant therapy OTHER

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.

Hemodynamically stable patients with very low risk symptomatic acute pulmonary embolism (PE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (10)

Hospital Clinic

Barcelona, Spain

NOT YET RECRUITING

Hospital General Universitari de Castelló

Castelló, Spain

NOT YET RECRUITING

Hospital Universitario Donostia

Donostia / San Sebastian, 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, 28027, Spain

NOT YET RECRUITING

Hospital Gregorio Marañón

Madrid, Spain

NOT YET RECRUITING

Hospital Ramón y Cajal

Madrid, Spain

RECRUITING

Complejo Hospitalario Virgen del Rocío

Seville, Spain

NOT YET RECRUITING

Hospital Doctor Peset

Valencia, Spain

NOT YET RECRUITING

MeSH Terms

Interventions

Ambulatory Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• PEDRO Ruiz-Artacho, PhD, MD

  Clínica Universidad de Navarra, Madrid (España)

  STUDY DIRECTOR

• Raquel Morillo Guerrero, PhD, MD

  Hospital Ramón y Cajal, Madrid (España)

  STUDY DIRECTOR

• DAVID Jiménez Castro, PhD, MD

  Hospital Ramón y Cajal, Madrid (España)

  STUDY DIRECTOR

• Deisy Barrios Barreto, PhD, MD

  Hospital Ramón y Cajal, Madrid (España)

  STUDY DIRECTOR

• Pablo Demelo Rodríguez, PhD, MD

  Hospital Universitario Gregorio Marañón, Madrid (España)

  PRINCIPAL INVESTIGATOR

• Alberto García-Ortega, PhD, MD

  Hospital Doctor Peset, Valencia (España)

  PRINCIPAL INVESTIGATOR

• Andrea Pérez Figuera, MD

  Hospital Ramón y Cajal, Madrid (España)

  STUDY DIRECTOR

• Elena Hernando López, MD

  Hospital San Pedro, Logroño (España)

  PRINCIPAL INVESTIGATOR

• Luis Jara Palomares, PhD, MD

  Complejo Hospitalario Virgen del Rocío, Sevilla (España)

  PRINCIPAL INVESTIGATOR

• Jorge Moisés Lafuente, MD

  Hospital Clinic (España)

  PRINCIPAL INVESTIGATOR

• Ignacio Casado Moreno, MD

  Hospital Universitario Virgen de las Nieves, Granada (España

  PRINCIPAL INVESTIGATOR

• Tina Rivas, MD

  Hospital Universitario Donostia (España)

  PRINCIPAL INVESTIGATOR

• Daniel Segura Ayala, MD

  Hospital General Universitari de Castelló (España)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PEDRO Ruiz-Artacho, PhD, MD

CONTACT

636781570; pruiza@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 10, 2023
• Study Start: April 10, 2023
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: May 10, 2023

Record last verified: 2023-04

Locations

ES (10)