Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Traumatic brain injury (TBI) causes acute deficits in cerebral perfusion which may lead to secondary injury and worse outcomes. Inhaled nitric oxide (iNO) is a vasodilator that increases cerebral blood flow and is clinically used for hypoxic respiratory failure in neonates and adults. The investigators will perform a randomized controlled trial of iNO treatment in TBI patients acutely after injury. The investigators will then assess perfusion changes with optic neuromonitoring, blood biomarkers, and 6 month clinical outcomes.

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

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

1. Age 18-75 (inclusive)

2. Male or Female

3. GCS 9-12 or GCS 13-15 with an abnormal imaging scan

4. Loss of consciousness for 30 minutes to 24 hours

5. Post traumatic amnesia 1 day

6. Radiologic findings indicative of primarily diffuse TBI

7. Both Intubated and nonintubated patients

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 large vessel disease

6. Acute Respiratory Distress Syndrome (ARDS) or pre-existing pulmonary hypertension

7. Cardiopulmonary resuscitation or cardioversion at admission

8. Transfusion at admission

9. Chronic Kidney Disease (Glomerular Filtration Rate 60mL/min/1.73m2)