Clinical trial • Not applicable • Respiratory | Cardiology
OXYGEN for Acute pulmonary embolism
Not applicable trial of OXYGEN for Acute pulmonary embolism. Randomised. 4050 participants.
Overview
- Trial Therapeutic Area
- Respiratory | Cardiology
- Trial Disease
- Acute pulmonary embolism
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-03-2024
- First CTIS Authorization Date
- 27-05-2024
Trial design
Randomised Not applicable trial across 50 sites in Spain, Italy.
- Randomised
- Yes
- Target Sample Size
- 4050
- Trial Duration For Participant
- 90
Eligibility
Recruits 4050 No vulnerable population selected (isVulnerablePopulationSelected: false). Trial enrols adults only (age <18 excluded). Subject information sheets and informed consent forms are provided (documents available in English, Spanish and Italian)..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Trial enrols adults only (age <18 excluded). Subject information sheets and informed consent forms are provided (documents available in English, Spanish and Italian).
Inclusion criteria
- {"criterion_text":"- Pulmonary embolism confirmed by multidetector computed tomographic pulmonary angiography\n- Right ventricular enlargement confirmed by computed tomography (transverse view) or echocardiography (apical or subcostal four chamber) where the right ventricle/left ventricle ratio is >1.0"}
Exclusion criteria
- {"criterion_text":"- Age less than 18 years\n- Participating in any other investigational drug or device study\n- Life expectancy <90 days at the discretion of the enrolling clinician\n- Oxygen saturation of less than 90% on pulse oximetry at the time of diagnosis\n- Technically inadequate basal computed tomography or echocardiography that prohibits the measurement of the right and left ventricle dimensions\n- Use of chronic oxygen therapy\n- Known hypercapnia (pCO2 >50 mmHg on arterial blood gases) at the time of diagnosis\n- Contraindication to anticoagulant therapy according to the physician judgement\n- Time elapsed since index diagnosis of pulmonary embolism symptom >10 days\n- Hemodynamic collapse at the time of PE diagnosis, defined as: need for cardiopulmonary resuscitation; or systolic blood pressure <90 mmHg for at least 15 min, or drop of systolic blood pressure by at least 40 mmHg for at least 15 min with signs of end organ hypoperfusion (cold extremities or low urinary output <30 mL/h or mental confusion); or need for catecholamine administration to maintain adequate organ perfusion and a systolic blood pressure of >90 mmHg\n- Inability to use mask or nasal prongs"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Composite of hemodynamic collapse or death from any cause within 30 days after enrollment.","definition_or_measurement_approach":"Composite of hemodynamic collapse or death from any cause assessed within 30 days after enrollment (timepoint specified as within 30 days after enrollment)."}
Secondary endpoints
- {"endpoint_text":"- Death from any cause within 30 days after enrollment","definition_or_measurement_approach":"All-cause mortality assessed within 30 days after enrollment."}
- {"endpoint_text":"- Hemodynamic collapse within 30 days after enrollment","definition_or_measurement_approach":"Occurrence of hemodynamic collapse assessed within 30 days after enrollment."}
- {"endpoint_text":"- Pulmonary embolism-related mortality within 30 days after enrollment","definition_or_measurement_approach":"Mortality adjudicated as related to pulmonary embolism within 30 days after enrollment."}
- {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":"Duration of hospitalisation measured in days."}
- {"endpoint_text":"- Death from any cause within 90 days after enrollment","definition_or_measurement_approach":"All-cause mortality assessed within 90 days after enrollment."}
- {"endpoint_text":"- Serious adverse events within 30 days after enrollment","definition_or_measurement_approach":"Occurrence of serious adverse events assessed within 30 days after enrollment."}
- {"endpoint_text":"- Major bleeding within 30 days after enrollment","definition_or_measurement_approach":"Occurrence of major bleeding events assessed within 30 days after enrollment."}
- {"endpoint_text":"- Recurrent symptomatic venous thromboembolism within 30 days after enrollment","definition_or_measurement_approach":"Occurrence of recurrent symptomatic VTE assessed within 30 days after enrollment."}
Recruitment
- Registry Or Advocacy Recruitment
- True - RIETE
- Planned Sample Size
- 4050
- Recruitment Window Months
- 51
- Consent Approach
- Informed consent obtained from participants (adults; age <18 excluded). Subject information sheets and informed consent forms are available in English, Spanish and Italian (documents listed: L1_SIS and ICF ENG/ES/IT; L1_SIS RIETE ENG; L1_ICF RIETE ENG/ES).
Geography
- Total Number Of Sites
- 50
- Total Number Of Participants
- 4050
Spain
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 634
- Number Of Sites
- 39
- Number Of Participants
- 3900
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Pneumology
- Contact Person Name
- David Jiménez Castro
- Contact Person Email
- djimenez.hrc@gmail.com
- Site Name
- Hospital Del Mar
- Department Name
- Pneumology
- Contact Person Name
- Jose Gregorio González García
- Contact Person Email
- jggonzalezgarcia@psmar.cat
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Pneumology
- Contact Person Name
- Alberto García Ortega
- Contact Person Email
- albortgva@gmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Pneumology
- Contact Person Name
- María del Carmen Fernández Marín
- Contact Person Email
- cfmar7@hotmail.com
- Site Name
- Fundacion De investigacion De Hm Hospitales
- Department Name
- Internal Medicine
- Contact Person Name
- José Felipe Varona Arche
- Contact Person Email
- jfvarona@hmhospitales.com
- Site Name
- Hospital General De Segovia
- Department Name
- Pneumology
- Contact Person Name
- Sofía Valeria Yerovi Onofre
- Contact Person Email
- sovaga_17@hotmail.com
- Site Name
- Hospital General Universitario De Castellon
- Department Name
- Peris
- Contact Person Name
- Selene Cuenca
- Contact Person Email
- selenecp@gmail.com
- Site Name
- Hospital Costa Del Sol
- Department Name
- Pneumology
- Contact Person Name
- María Pérez Morales
- Contact Person Email
- mariaperezmorales7@gmail.com
- Site Name
- Hospital Central De La Defensa Gomez Ulla
- Department Name
- Pneumology
- Contact Person Name
- Sergio Campos Téllez
- Contact Person Email
- sctlrg2005@gmail.com
- Site Name
- Hospital Vega Baja De Orihuela
- Department Name
- Internal Medicine
- Contact Person Name
- Manuel Alejandro Lorente García
- Contact Person Email
- maallogar@hotmail.com
- Site Name
- Parc Sanitari Sant Joan De Deu
- Department Name
- Internal Medicine
- Contact Person Name
- Pablo Javier Marchena Yglesias
- Contact Person Email
- pjmy1@yahoo.es
- Site Name
- Hospital General Universitario Morales Meseguer
- Department Name
- Internal Medicine
- Contact Person Name
- Javier Pagán Escribano
- Contact Person Email
- pagan02468@gmail.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Pneumology
- Contact Person Name
- Paloma Ruiz Torregrosa
- Contact Person Email
- paloma.91ruiz@gmail.com
- Site Name
- Hospital Universitario Infanta Sofía
- Department Name
- Internal Medicine
- Contact Person Name
- Mar Martín del Pozo
- Contact Person Email
- mar.martin.pozo@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Internal Medicine
- Contact Person Name
- Pablo Demelo Rodríguez
- Contact Person Email
- pbdemelo@hotmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Internal Medicine
- Contact Person Name
- María del Carmen Díaz Pedroche
- Contact Person Email
- cdiazpedroche@gmail.com
- Site Name
- Hospital Universitario Rey Juan Carlos
- Department Name
- Internal Medicine
- Contact Person Name
- María Angelina García
- Contact Person Email
- mangelina@hospitalreyjuancarlos.es
- Site Name
- University Hospital Son Espases
- Department Name
- Pneumology
- Contact Person Name
- Alicia Binimelis Varella
- Contact Person Email
- abinimelis@ssib.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Internal Medicine
- Contact Person Name
- Cristina Barbagelata López
- Contact Person Email
- cristina.barbagelata.lopez@sergas.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Internal Medicine
- Contact Person Name
- Giorgina Salgueiro Origlia
- Contact Person Email
- giorgisalgueiro@hotmail.com
- Site Name
- Hospital Universitario De Getafe
- Department Name
- Internal Medicine
- Contact Person Name
- Diego Durán Barata
- Contact Person Email
- diego.duranb@hotmail.com
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Internal Medicine
- Contact Person Name
- Iria Francisco Albesa
- Contact Person Email
- ifrancisco.girona.ics@gencat.cat
- Site Name
- Hospital General Universitario De Albacete
- Department Name
- Pneumology
- Contact Person Name
- Patricia López Miguel
- Contact Person Email
- patricialopezmiguel@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Pneumology
- Contact Person Name
- Luis Jara Palomares
- Contact Person Email
- luisoneumo@hotmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Internal Medicine
- Contact Person Name
- Pedro Ruiz Artacho
- Contact Person Email
- ruizpedroc@gmail.com
- Site Name
- Hospital Universitario De Burgos
- Department Name
- Pneumology
- Contact Person Name
- Carmen Fernández de Martínez de Septién
- Contact Person Email
- carmenfms@saludcastillayleon.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Internal Medicine
- Contact Person Name
- Juan José López Núñez
- Contact Person Email
- juanjolopezn@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Internal Medicine
- Contact Person Name
- Pedro Parra Caballero
- Contact Person Email
- pedroatletico@hotmail.com
- Site Name
- Clinica Universidad De Navarra (Madrid site)
- Department Name
- Internal Medicine
- Contact Person Name
- Pedro Ruiz Artacho
- Contact Person Email
- ruizpedroc@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Internal Medicine
- Contact Person Name
- Leticia Guirado Torrecillas
- Contact Person Email
- leticia.guiradotorrecillas@gmail.com
- Site Name
- Hospital Universitario Del Vinalopo
- Department Name
- Internal Medicine
- Contact Person Name
- Ana Maestre Peiró
- Contact Person Email
- amaestrep@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Emergency
- Contact Person Name
- Sonia Jiménez Hernández
- Contact Person Email
- SJIMENEZ@clinic.cat
- Site Name
- Hospital Universitario De La Princesa (additional contact)
- Department Name
- Pneumology
- Contact Person Name
- Emma Vázquez Espinosa
- Contact Person Email
- evazqueze@hotmail.com
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Pneumology
- Contact Person Name
- Jacinto Hernández Borge
- Contact Person Email
- jacinto.borge@telefonica.net
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Internal Medicine
- Contact Person Name
- Vanesa Sendin Martín
- Contact Person Email
- vsendinm82@yahoo.es
- Site Name
- Hospital De Galdakao Usansolo
- Department Name
- Pneumology
- Contact Person Name
- Aitor Ballaz Quincoces
- Contact Person Email
- aitor.ballazquincoces@osakidetza.eus
- Site Name
- Hospital General Universitario Gregorio Maranon (additional contact)
- Department Name
- Pneumology
- Contact Person Name
- Javier De Miguel Díez
- Contact Person Email
- jdemigueldiez@telefonica.net
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Pneumology
- Contact Person Name
- Amaya Martínez Meñaca
- Contact Person Email
- amayamm87@gmail.com
- Site Name
- Hospital Recoletas Campo Grande
- Department Name
- Pneumology
- Contact Person Name
- Beatriz Pintado Cort
- Contact Person Email
- beitsap@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 07-07-2025
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 221
- Number Of Sites
- 11
- Number Of Participants
- 150
Sites
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Emergency
- Contact Person Name
- Simone Vanni
- Contact Person Email
- simone.vanni@unifi.it
- Site Name
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
- Department Name
- Emergency
- Contact Person Name
- Enrico Bernardi
- Contact Person Email
- enrico.bernardi@aulss2.veneto.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Emergency
- Contact Person Name
- Enrico Lupia
- Contact Person Email
- enrico.lupia@unito.it
- Site Name
- Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
- Department Name
- Internal and Emergency Medicine
- Contact Person Name
- Marco Paolo Donadini
- Contact Person Email
- marcopaolo.donadini@uninsubria.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Emergency and Internal Medicine
- Contact Person Name
- Cinzia Nitti
- Contact Person Email
- cinzia_nitti@libero.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Emergency
- Contact Person Name
- Francesca Daniela Gianni
- Contact Person Email
- gianni.fra@gmail.com
- Site Name
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Department Name
- Emergency
- Contact Person Name
- Matteo Borselli
- Contact Person Email
- matteo.borselli@gmail.com
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Emergency
- Contact Person Name
- Stefano Perlini
- Contact Person Email
- stefano.perlini@unipv.it
- Site Name
- Universita' Degli Studi Di Perugia
- Department Name
- Internal, Cardiovascular and Emergency Medicine
- Contact Person Name
- Cecilia Becattini
- Contact Person Email
- cecilia.becattini@unipg.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Emergency
- Contact Person Name
- Francesco Franceschi
- Contact Person Email
- francesco.franceschi@unicatt.it
- Site Name
- Azienda Unita' Sanitaria Locale Toscana Nord Ovest
- Department Name
- Emergency
- Contact Person Name
- Giuseppe Pepe
- Contact Person Email
- giuseppe.pepe@uslnordovest.toscana.it
Sponsor
Primary sponsor
- Full Name
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- OXYGEN
- Active Substance
- OXYGEN
- Modality
- Small molecule
- Routes Of Administration
- INHALATION GAS
- Route
- INHALATION GAS
- Authorisation Status
- Authorised
- Maximum Dose
- 31 % (V/V) percent volume/volume
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