Table 1.

COBRIT Inclusion and Exclusion Criteria

Inclusion criteria:

• Non-penetrating traumatic brain injury

• Age 18 (19 in Alabama) to 70 years

• GCS criteria:

GCS obtained off paralytics:

GCS 3–12 with GCS motor score ≤5

GCS 3–12 with GCS motor score =6 and meeting ANY of the following CT criteria:

• ≥10 mm total diameter intraparenchymal hemorrhage

• Acute extra-axial hematoma thickness ≥5 mm

• Contiguous subarachnoid hemorrhage visible on two or more contiguous slices on CT

• Intraventricular hemorrhage present on two slices

• Midline shift ≥5 mm

GCS 13–15 meeting the above CT criteria

GCS obtained on paralytics:

GCS 3TP (intubated and paralyzed) meeting the above CT criteria

• Reasonable expectation of completion of outcomes measures at a network center at 6 months post-injury

• Able to swallow oral medication, or if unable to swallow, a gastric tube or PEG are placed by 23 hours after injury

• Reasonable expectation of enrollment within 24-h time window

• English-speaking

Exclusion criteria:

• Intubated patients with GCS motor score = 6 and not meeting CT criteria

• Bilaterally fixed and dilated pupils

• Positive pregnancy test, known pregnancy, or current breast-feeding

• Evidence of disease that interferes with outcome assessment

• Current acetylcholinesterase inhibitor use

• Current citicoline use and unwilling to discontinue

• Imminent death or current life-threatening disease

• Current enrollment in another study

• Prisoner

PEG, percutaneous endoscopic gastrostomy; GCS, Glasgow Coma Scale; CT computed tomography; COBRIT, Citicoline Brain Injury Treatment trial.