Acute Pulmonary EmbolismTRAMTEPNCT05852119
Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism.
A study testing Outpatient treatment with standard anticoagulant therapy in people with Acute Pulmonary Embolism and Outpatient Treatment, run by Clinica Universidad de Navarra, Universidad de Navarra at 10 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pulmonary Embolism, Outpatient Treatment
- What is being tested?
- Outpatient treatment with standard anticoagulant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 10 sitesSpain
- Study dates
- 10 Apr 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites, 10 recruiting
- Not yet recruiting
Hospital Clinic
Barcelona
Jorge Moisés Lafuente
Jorge Moisés Lafuente
- Not yet recruiting
Hospital General Universitari de Castelló
Castelló
Daniel Segura Ayala
Daniel Segura Ayala
- Not yet recruiting
Hospital Universitario Donostia
Donostia / San Sebastian
Tina Rivas
Tina Rivas
- Not yet recruiting
Hospital Universitario Virgen de las Nieves
Granada
Ignacio Casado Moreno
Ignacio Casado Moreno
- Not yet recruiting
Hospital San Pedro
Logroño
Elena Hernando López
Elena Hernando López
- Not yet recruiting
Clínica Universidad Navarra
Madrid, 28027
PEDRO Ruiz-Artacho, PhD, 636781570, pruiza@unav.es
Pedro Ruiz-Artacho, PhD
- Not yet recruiting
Hospital Gregorio Marañón
Madrid
Pablo Demelo Rodríguez, PhD
Pablo Demelo Rodríguez, PhD
- Recruiting
Hospital Ramón y Cajal
Madrid
Raquel Morillo Guerrero, PhD
Raquel Morillo Guerrero, PhD
- Not yet recruiting
Complejo Hospitalario Virgen del Rocío
Seville
Luis Jara Palomares
Luis Jara Palomares
- Not yet recruiting
Hospital Doctor Peset
Valencia
Alberto García-Ortega
Alberto García-Ortega
About this study
Official title: 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.
Read more
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
- Being tested
- Outpatient treatment with standard anticoagulant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient treatment with standard anticoagulant therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamically stable patients with very low risk symptomatic acute pulmonary embolism (PE) | Experimental | Not described Receives: Other: Outpatient treatment with standard anticoagulant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
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).
Measured: 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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start10 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PEDRO Ruiz-Artacho, PhD, MD, Study director, Clínica Universidad de Navarra, Madrid (España)Raquel Morillo Guerrero, PhD, MD, Study director, Hospital Ramón y Cajal, Madrid (España)DAVID Jiménez Castro, PhD, MD, Study director, Hospital Ramón y Cajal, Madrid (España)Deisy Barrios Barreto, PhD, MD, Study director, Hospital Ramón y Cajal, Madrid (España)Pablo Demelo Rodríguez, PhD, MD, Principal investigator, Hospital Universitario Gregorio Marañón, Madrid (España)Alberto García-Ortega, PhD, MD, Principal investigator, Hospital Doctor Peset, Valencia (España)Andrea Pérez Figuera, MD, Study director, Hospital Ramón y Cajal, Madrid (España)Elena Hernando López, MD, Principal investigator, Hospital San Pedro, Logroño (España)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852119
- Sponsor's protocol ID
- 295-22
- Acronym
- TRAMTEP
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism. TRAMTEP Study.
- ClinicalTrials.gov ID
- NCT05852119
- Acronym / sponsor ID
- TRAMTEP / 295-22
- Conditions
- Acute Pulmonary Embolism, Outpatient Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodynamically stable patients with very low risk symptomatic acute pulmonary embolism (PE) | Experimental | Other: Outpatient treatment with standard anticoagulant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient treatment with standard anticoagulant therapyAll 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. | Other | Hemodynamically stable patients with very low risk symptomatic acute pulmonary embolism (PE) |
Primary outcome
Composite of recurrent pulmonary embolism (PE), major bleeding, or death from any cause.
Time frame: 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.
2 secondary outcomes
Satisfaction of the patients
Time frame: 30 days
Quality of life of the patients
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PEDRO Ruiz-Artacho, PhD, MD study director
Clínica Universidad de Navarra, Madrid (España)
Raquel Morillo Guerrero, PhD, MD study director
Hospital Ramón y Cajal, Madrid (España)
DAVID Jiménez Castro, PhD, MD study director
Hospital Ramón y Cajal, Madrid (España)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient treatment with standard anticoagulant therapy in people with Acute Pulmonary Embolism and Outpatient Treatment, run by Clinica Universidad de Navarra, Universidad de Navarra at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PEDRO Ruiz-Artacho, PhD, MD (636781570, pruiza@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of recurrent pulmonary embolism (PE), major bleeding, or death from any cause. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.