Effect of iNO in Patients With Submassive and Massive PE

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

A single center study to evaluate the effect of inhaled nitric oxide (iNO) on pulmonary dynamics in patients presenting with imaging confirmed intermediate/submassive or massive pulmonary embolism (PE). The target enrollment is 20 subjects at Ronald Reagan UCLA Medical Center. PE patients undergoing catheter-based intervention will be administered iNO during their intervention and pulmonary hemodynamic measurement will be measured before, during, and after iNO administration (Invasive Cohort). Patients who are not undergoing catheter-based intervention will also be administered iNO and will have pulmonary hemodynamics, blood pressure, and heart rate measured non-invasively (Non-Invasive Cohort).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: Mallinckrodt
• Treatments: Nitric Oxide

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