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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-08-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

oral N-acetyl cysteine and oral multivitamin tablets

Group Type EXPERIMENTAL

N-Acetyl cysteine

Intervention Type DRUG

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

Non-Treatment

Routine Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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N-Acetyl cysteine

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

Intervention Type DRUG

Other Intervention Names

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Multi-vitamins with minerals

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No