BridgeMD
Registry-based randomized trial to determine the role of Oxygen in acute Pulmonary Embolism
EU CTIS ID: 2024-511959-18-01
What this study is testing
To evaluate the efficacy of supplemental oxygen in patients with intermediate-risk acute pulmonary embolism at day 30.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pulmonary embolism confirmed by multidetector computed tomographic pulmonary angiography
- 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
You likely can't join if
- Age less than 18 years
- Participating in any other investigational drug or device study
- Life expectancy <90 days at the discretion of the enrolling clinician
- Oxygen saturation of less than 90% on pulse oximetry at the time of diagnosis
- Technically inadequate basal computed tomography or echocardiography that prohibits the measurement of the right and left ventricle dimensions
- Use of chronic oxygen therapy
See the full eligibility criteria
- Pulmonary embolism confirmed by multidetector computed tomographic pulmonary angiography
- 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
- Age less than 18 years
- Participating in any other investigational drug or device study
- Life expectancy <90 days at the discretion of the enrolling clinician
- Oxygen saturation of less than 90% on pulse oximetry at the time of diagnosis
- Technically inadequate basal computed tomography or echocardiography that prohibits the measurement of the right and left ventricle dimensions
- Use of chronic oxygen therapy
- Known hypercapnia (pCO2 >50 mmHg on arterial blood gases) at the time of diagnosis
- Contraindication to anticoagulant therapy according to the physician judgement
- Time elapsed since index diagnosis of pulmonary embolism symptom >10 days
- 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
- Inability to use mask or nasal prongs
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.