Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT04996667
Eligibility Criteria:
Inclusion Criteria:
* Patient ≥ 18 years of age.
* The patient or patient's surrogate decision maker must understand and sign the informed consent form (ICF).
* Hospitalized (Emergency Room (ER) or inpatient) with:
* Imaging (computed tomography pulmonary angiography (CTPA) or ventilation/perfusion (VQ) lung scan) proven acute pulmonary embolism (PE)
* PE meets the following intermediate risk PE criteria (or massive, see below):
* Troponin \> .1 AND
* Imaging (computed tomography (CT) or transthoracic echocardiogram (TTE)) signs of RV compromise (at least 1 of the following):
* RV:LV\>1 on TTE or CTPA OR RV dilation (TTE or CTPA OR RV dysfunction on TTE.
* Massive PE
* Intensive care unit (ICU) level of care (Patient moving to ICU, ICU level of care in ER, or currently in ICU)
* Ability to comply with study protocol in investigator's judgement
Exclusion Criteria:
* Pregnancy or breastfeeding
* Inability to administer iNO through current mode of O2 delivery (i.e. BiPAP)
* Active hemoptysis
* Known allergy to iNO.
* Any serious medical condition of lab abnormality that, in the investigator's judgement, precludes the patient's safe participation in the study.
* Methemoglobin reductase deficiency
* Unable to obtain consent or patient or patient surrogate decision maker declines
* Patients already on iNO prior to study enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04996667
Study Brief:
Protocol Section:
NCT04996667