Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury

Launched by UNIVERSITY OF PENNSYLVANIA · Nov 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called inhaled nitric oxide (iNO) for patients who have suffered a traumatic brain injury (TBI). TBI can cause problems with blood flow to the brain, which may lead to further damage. In this study, researchers will provide iNO to TBI patients soon after their injury to see if it can improve blood flow in the brain and help with recovery. They will monitor changes in blood flow and check patients’ health over the next six months.

To participate, patients need to be between 18 and 75 years old and have a specific level of consciousness and brain imaging results indicating a type of TBI. However, those with certain serious heart conditions, significant brain injuries requiring immediate surgery, or other serious health issues will not be eligible. This study is still in the planning phase and is not yet recruiting participants. If you or a loved one has experienced a TBI and meet the criteria, this trial could be an important opportunity to explore a potential treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-75 (inclusive)
• • 2. GCS 9-12 or GCS 13-15 with an abnormal imaging scan
• • 3. Radiologic findings indicative of primarily diffuse TBI
• Exclusion Criteria:
• • 1. Severe cardiac dysfunction (e.g. elevation of pulmonary edema on chest xray, large elevation of cardiac enzymes)
• • 2. Large focal injury (subdural hematoma, epidural hematoma, intraparenchymal hematoma, \>30mL aggregate volume).
• • 3. Need for immediate neurosurgical intervention
• • 4. Pre-existing disabling psychiatric or neurological disorders such as cortical stroke, brain tumor, disabling multiple sclerosis, dementia, and severe TBI
• • 5. Known intracranial vessel disease
• • 6. Acute Respiratory Distress Syndrome (ARDS) or pre-existing pulmonary hypertension
• • 7. Cardiopulmonary resuscitation or cardioversion at admission
• • 8. Chronic Kidney Disease (Glomerular Filtration Rate \<60mL/min/1.73m2)
• • 9. Respiratory Infection
• • 10. Prisoners, patients in police custody, pregnant women
• • 11. Possible drug interactions (nitric oxide donors: prilocaine, sodium nitroprusside, nitroglycerin)