Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients

HonorHealth Research Institute92 enrolled

Overview

This study will evaluate the administration of N-Acetyl-cysteine in combination with multi-vitamins/minerals in geriatric population (\>60 years of age) who have experienced a traumatic brain injury.

This study aims to determine the effect of supplemental N-acetyl cysteine and additional multi-vitamin/mineral therapy on somatic, cognitive, and emotional post-concussion symptoms as determined by the Rivermeade Post-concussion Questionnaire (RPQ) within 24 hours of admission, post injury day 7, and post injury day 30. The RPQ questionnaires will be given to patients older than 60 years, who have been evaluated by the HonorHealth John C. Lincoln Medical Center or Deer Valley Medical Center trauma service within 3 hours of sustaining a traumatic brain injury (TBI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

N-Acetyl cysteineDRUG

Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI

Eligibility

Sex: ALLMin age: 60 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 60 years or older * present to emergency department within 3 hours of documented TBI Exclusion Criteria: * patients without TBI * patients with a history of TBI greater than 3 hours prior to presentation * patients under the age of 60 * currently enrolled in an ongoing research study * patients who at baseline prior to the TBI, cannot participate in cognitive function testing (aphasia, severe dementia, non verbal; prior to TBI) * Patients who are unable to tolerate PO medications within 3 hours of sustaining TBI.

Locations (2)

HonorHealth John C. Lincoln Medical Center

Phoenix, Arizona, United States

HonorHealth Deer Valley Medical Center

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Determine Improvement in Somatic, Cognitive, and Emotional Post-concussion Symptoms as Measured by the Rivermeade Post-concussion Questionnaire (RPQ) in Treatment Group vs Non-treatment Group.

Somatic, cognitive, and emotional post-concussion symptoms as measured by, RPQ scores within 24 hours of admission (Day 0), post injury (Day 7), and post injury (Day 30). The scale goes based on a 0 = not experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, 4 = a severe problem. The RPQ scores can range between 0 and 64 where higher scores indicate more severe symptoms.

Time frame: 0 to 30 days post traumatic brain injury event

Secondary Outcomes

Glasgow Coma Scale (GCS) at Arrival and Discharge

The Glasgow Coma Scale (GCS) is a clinical tool used to assess a person's level of consciousness after a brain injury. The scale covers three primary domains with associated sub scores to generate a total GCS score ranging from 3 - 15. A total score of 3 -8 notes severe dysfunction, 9 - 12 moderate dysfunction, and 13 - 15 mild dysfunction. Sub scores are evaluated as follows: Eye Opening (Score range 1 -4): 1 - None, 2 - To pressure, 3 - To sound, 4 - Spontaneous. Verbal Response (Score range 1-5): 1 - None, 2 - Sounds, 3 - Words, 4 - Confused, 5 - Orientated. Motor Response (Score range 1-6): 1 - None, 2 - Extension, 3 - Abnormal flexion, 4 - Normal flexion, 5 - Localizing, 6 - Obey commands.

Time frame: Day 0 Score on arrival through subject discharge post traumatic brain injury event at approximately 30 days

Data from ClinicalTrials.gov

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