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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pulmonary Embolism; Outpatient Treatment
• Intervention / Treatment: Other: Outpatient treatment with standard anticoagulant therapy

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PEDRO Ruiz-Artacho, PhD, MD; Phone Number: 636781570; Email: pruiza@unav.es

Study Locations

• Spain
  • Barcelona, Spain
    • Not yet recruiting
    • Hospital Clínic
    • Contact: Jorge Moisés Lafuente
    • Principal Investigator: Jorge Moisés Lafuente
    • Sub-Investigator: Sònia Jiménez Hernández
  • Castelló, Spain
    • Not yet recruiting
    • Hospital General Universitari de Castelló
    • Contact: Daniel Segura Ayala
    • Principal Investigator: Daniel Segura Ayala
    • Sub-Investigator: Ana Torrents Vilar
  • Donostia, Spain
    • Not yet recruiting
    • Hospital Universitario Donostia
    • Contact: Tina Rivas
    • Principal Investigator: Tina Rivas
    • Sub-Investigator: José Ignacio Royo Gutiérrez
  • Granada, Spain
    • Not yet recruiting
    • Hospital Universitario Virgen de las Nieves
    • Contact: Ignacio Casado Moreno
    • Principal Investigator: Ignacio Casado Moreno
  • Logroño, Spain
    • Not yet recruiting
    • Hospital San Pedro
    • Contact: Elena Hernando López
    • Principal Investigator: Elena Hernando López
  • Madrid, Spain
    • Recruiting
    • Hospital Ramon y Cajal
    • Contact: Raquel Morillo Guerrero, PhD
    • Principal Investigator: Raquel Morillo Guerrero, PhD
    • Sub-Investigator: David Jiménez Castro, PhD
    • Sub-Investigator: Deisy Barrios Barreto, PhD
    • Sub-Investigator: Andrea Pérez Figuera, MD
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Gregorio Marañón
    • Contact: Pablo Demelo Rodríguez, PhD
    • Principal Investigator: Pablo Demelo Rodríguez, PhD
  • Madrid, Spain, 28027
    • Not yet recruiting
    • Clinica Universidad Navarra
    • Contact: PEDRO Ruiz-Artacho, PhD; Phone Number: 636781570; Email: pruiza@unav.es
    • Principal Investigator: Pedro Ruiz-Artacho, PhD
  • Sevilla, Spain
    • Not yet recruiting
    • Complejo Hospitalario Virgen del Rocío
    • Principal Investigator: Luis Jara Palomares
    • Contact: Luis Jara Palomares
    • Sub-Investigator: María Barca Hernando
  • Valencia, Spain
    • Not yet recruiting
    • Hospital Doctor Peset
    • Contact: Alberto García-Ortega
    • Principal Investigator: Alberto García-Ortega

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemodynamically stable patients with very low risk symptomatic acute pulmonary embolism (PE)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of the patients	The satisfaction of the patients will be evaluated on day 30 of follow-up using the Patient Satisfaction Questionnaire (PSQ-18).	30 days
Quality of life of the patients	Quality of life of the patients will be evaluated on day 30 of follow-up using the Pulmonary Thromboembolism Quality of Life Questionnaire (PEmb-Qol).	30 days

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: Study Director: 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); Principal Investigator: Pablo Demelo Rodríguez, PhD, MD, Hospital Universitario Gregorio Marañón, Madrid (España); Principal Investigator: Alberto García-Ortega, PhD, MD, Hospital Doctor Peset, Valencia (España); Study Director: Andrea Pérez Figuera, MD, Hospital Ramón y Cajal, Madrid (España); Principal Investigator: 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)

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): February 28, 2026

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Anticoagulants
• Other Study ID Numbers: 295-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No