Registry-based randomized trial to determine the role of Oxygen in acute Pulmonary Embolism

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

1 Jul 2024 → ongoing

Decision date (initial)

2025-08-26

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of supplemental oxygen in patients with intermediate-risk acute pulmonary embolism at day 30.

Secondary objectives 5

1. To evaluate the effect of supplemental oxygen on all-cause mortality of patients with intermediate-risk acute pulmonary embolism at days 30 and 90.
2. To evaluate the effect of supplemental oxygen on PE-related mortality of patients with intermediate-risk acute pulmonary embolism at day 30.
3. To study the effect of supplemental oxygen on the length of hospital stay.
4. To evaluate the safety of supplemental oxygen in patients with intermediate-risk acute pulmonary embolism at day 30.
5. To study if the effect of supplemental oxygen differs between pre-specified subgroups.

Conditions and MedDRA coding

Acute Pulmonary Embolism

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Pulmonary embolism confirmed by multidetector computed tomographic pulmonary angiography
2. 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 11

1. Age less than 18 years
2. Oxygen saturation of less than 90% on pulse oximetry at the time of diagnosis
3. Technically inadequate basal computed tomography or echocardiography that prohibits the measurement of the right and left ventricle dimensions
4. Use of chronic oxygen therapy
5. Known hypercapnia (pCO2 >50 mmHg on arterial blood gases) at the time of diagnosis
6. Contraindication to anticoagulant therapy according to the physician judgement
7. Time elapsed since index diagnosis of pulmonary embolism symptom >10 days
8. 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
9. Inability to use mask or nasal prongs
10. Participating in any other investigational drug or device study
11. Life expectancy <90 days at the discretion of the enrolling clinician

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite of hemodynamic collapse or death from any cause within 30 days after enrollment.

Secondary endpoints 8

1. Death from any cause within 30 days after enrollment
2. Hemodynamic collapse within 30 days after enrollment
3. Pulmonary embolism-related mortality within 30 days after enrollment
4. Length of hospital stay
5. Death from any cause within 90 days after enrollment
6. Serious adverse events within 30 days after enrollment
7. Major bleeding within 30 days after enrollment
8. Recurrent symptomatic venous thromboembolism within 30 days after enrollment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Sponsor organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Address

Carretera Del Colmenar Viejo Km 9100, Por El Pardo Por El Pardo

City

Madrid

Postcode

28034

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Contact name

Mayra

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Contact name

Mayra

Locations

2 EU/EEA countries · 50 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications