TRAMTEP: Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Composite of recurrent pulmonary embolism (PE), major bleeding, or death from any cause. [30 days]
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 [30 days]
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 [30 days]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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);
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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
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Negatively modified simplified Pulmonary Embolism Severity Index (sPESI) scale at the time of evaluation of the patient in the Emergency Department.
Exclusion Criteria:
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Inability to obtain informed consent
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Pregnancy
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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)
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Contraindication for anticoagulation, at the discretion of the responsible physician;
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Estimated survival of less than 3 months
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Need for thrombectomy, vena cava filter insertion, or need for fibrinolytic treatment of the PE episode at the time of diagnosis
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Participation in a clinical trial for the treatment of venous thromboembolic disease
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Impossibility of follow up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinic | Barcelona | Spain | ||
| 2 | Hospital General Universitari de Castelló | Castelló | Spain | ||
| 3 | Hospital Universitario Donostia | Donostia | Spain | ||
| 4 | Hospital Universitario Virgen de las Nieves | Granada | Spain | ||
| 5 | Hospital San Pedro | Logroño | Spain | ||
| 6 | Clínica Universidad Navarra | Madrid | Spain | 28027 | |
| 7 | Hospital Gregorio Marañón | Madrid | Spain | ||
| 8 | Hospital Ramón y Cajal | Madrid | Spain | ||
| 9 | Complejo Hospitalario Virgen del Rocío | Sevilla | Spain | ||
| 10 | Hospital Doctor Peset | Valencia | Spain |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 295-22