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

Primary Purpose

Acute Pulmonary Embolism, Outpatient Treatment

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Outpatient treatment with standard anticoagulant therapy
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinic
  • Hospital General Universitari de Castelló
  • Hospital Universitario Donostia
  • Hospital Universitario Virgen de las Nieves
  • Hospital San Pedro
  • Clínica Universidad Navarra
  • Hospital Gregorio Marañón
  • Hospital Ramón y CajalRecruiting
  • Complejo Hospitalario Virgen del Rocío
  • Hospital Doctor Peset

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
April 26, 2023
Last Updated
May 9, 2023
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT05852119
Brief Title
Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism.
Acronym
TRAMTEP
Official Title
Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism. TRAMTEP Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pulmonary Embolism, Outpatient Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemodynamically stable patients with very low risk symptomatic acute pulmonary embolism (PE)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Outpatient treatment with standard anticoagulant therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite of recurrent pulmonary embolism (PE), major bleeding, or death from any cause.
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Satisfaction of the patients
Description
The satisfaction of the patients will be evaluated on day 30 of follow-up using the Patient Satisfaction Questionnaire (PSQ-18).
Time Frame
30 days
Title
Quality of life of the patients
Description
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).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PEDRO Ruiz-Artacho, PhD, MD
Phone
636781570
Email
pruiza@unav.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PEDRO Ruiz-Artacho, PhD, MD
Organizational Affiliation
Clínica Universidad de Navarra, Madrid (España)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raquel Morillo Guerrero, PhD, MD
Organizational Affiliation
Hospital Ramón y Cajal, Madrid (España)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
DAVID Jiménez Castro, PhD, MD
Organizational Affiliation
Hospital Ramón y Cajal, Madrid (España)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deisy Barrios Barreto, PhD, MD
Organizational Affiliation
Hospital Ramón y Cajal, Madrid (España)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pablo Demelo Rodríguez, PhD, MD
Organizational Affiliation
Hospital Universitario Gregorio Marañón, Madrid (España)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alberto García-Ortega, PhD, MD
Organizational Affiliation
Hospital Doctor Peset, Valencia (España)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Pérez Figuera, MD
Organizational Affiliation
Hospital Ramón y Cajal, Madrid (España)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elena Hernando López, MD
Organizational Affiliation
Hospital San Pedro, Logroño (España)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis Jara Palomares, PhD, MD
Organizational Affiliation
Complejo Hospitalario Virgen del Rocío, Sevilla (España)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge Moisés Lafuente, MD
Organizational Affiliation
Hospital Clinic (España)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ignacio Casado Moreno, MD
Organizational Affiliation
Hospital Universitario Virgen de las Nieves, Granada (España
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tina Rivas, MD
Organizational Affiliation
Hospital Universitario Donostia (España)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Segura Ayala, MD
Organizational Affiliation
Hospital General Universitari de Castelló (España)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Moisés Lafuente
First Name & Middle Initial & Last Name & Degree
Jorge Moisés Lafuente
First Name & Middle Initial & Last Name & Degree
Sònia Jiménez Hernández
Facility Name
Hospital General Universitari de Castelló
City
Castelló
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Segura Ayala
First Name & Middle Initial & Last Name & Degree
Daniel Segura Ayala
First Name & Middle Initial & Last Name & Degree
Ana Torrents Vilar
Facility Name
Hospital Universitario Donostia
City
Donostia
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Rivas
First Name & Middle Initial & Last Name & Degree
Tina Rivas
First Name & Middle Initial & Last Name & Degree
José Ignacio Royo Gutiérrez
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Casado Moreno
First Name & Middle Initial & Last Name & Degree
Ignacio Casado Moreno
Facility Name
Hospital San Pedro
City
Logroño
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Hernando López
First Name & Middle Initial & Last Name & Degree
Elena Hernando López
Facility Name
Clínica Universidad Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PEDRO Ruiz-Artacho, PhD
Phone
636781570
Email
pruiza@unav.es
First Name & Middle Initial & Last Name & Degree
Pedro Ruiz-Artacho, PhD
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Demelo Rodríguez, PhD
First Name & Middle Initial & Last Name & Degree
Pablo Demelo Rodríguez, PhD
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Morillo Guerrero, PhD
First Name & Middle Initial & Last Name & Degree
Raquel Morillo Guerrero, PhD
First Name & Middle Initial & Last Name & Degree
David Jiménez Castro, PhD
First Name & Middle Initial & Last Name & Degree
Deisy Barrios Barreto, PhD
First Name & Middle Initial & Last Name & Degree
Andrea Pérez Figuera, MD
Facility Name
Complejo Hospitalario Virgen del Rocío
City
Sevilla
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Jara Palomares
First Name & Middle Initial & Last Name & Degree
Luis Jara Palomares
First Name & Middle Initial & Last Name & Degree
María Barca Hernando
Facility Name
Hospital Doctor Peset
City
Valencia
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto García-Ortega
First Name & Middle Initial & Last Name & Degree
Alberto García-Ortega

12. IPD Sharing Statement

Learn more about this trial

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

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