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:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT04530032
Eligibility Criteria:
Inclusion Criteria:
* complicated mild (GCS 13-15), moderate (GCS 9 - 12) to severe (GCS ≤ 8) traumatic brain injury (TBI) between 2-30 days post injury
* Admitted to Loma Linda University surgical intensive care unit (SICU)
Exclusion Criteria:
* history of comorbid ischemic stroke following qualifying TBI
* history of premorbid brain injury with associated loss of consciousness
* history of psychiatric disorder
* history of premorbid neurological disorder or neurosurgical intervention
* pregnancy
* depressed GCS score due to acute intoxication
* liver dysfunction as defined by liver enzymes 5 times the upper limit of normal or chronic cirrhosis
* acute renal failure according to the Risk, Injury, Failure, Loss of kidney function, and End-stage kidenty disease (RIFLE) classification
* abdominal surgery during the same admission
* type 1 diabetes
* gastroparesis
* dyslipidemia
* severe asphasia
* known history of metabolic disorders that are a contradiction for ketogenic diet (KD) such as primary carnitine deficient, carnitine palmitoyltransferase (CPT) I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, pyruvate carboxylase deficiency, or porphyria
* prealbumin (transthyretin) levels of \<10 mg/dL within 3 days of admission
* Metal, implanted device (ICP monitor), pregnancy, claustrophobia, or other contraindication to MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
90 Years
Study:
NCT04530032
Study Brief:
Protocol Section:
NCT04530032