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

Sponsor
HonorHealth Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04291066
Collaborator
(none)
92
Enrollment
2
Locations
2
Arms
23
Actual Duration (Months)
46
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: N-Acetyl cysteine
 Phase 2

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

oral N-acetyl cysteine and oral multivitamin tablets

Drug: N-Acetyl cysteine
Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
Other Names:
  • Multi-vitamins with minerals

    		•
    No Intervention: Non-Treatment

    Routine Care

    Outcome Measures

    Primary Outcome Measures

    1. 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. [1 to 30 days post traumatic brain injury event]

      Somatic, cognitive, and emotional post-concussion symptoms as measured by, RPQ scores within 24 hours of admission, post injury day 7, and post injury day 30. The scale goes based on a zero to 4 grading system. Zero equaling "not experienced at all" to 4 equaling "a severe problem".

    Secondary Outcome Measures

    1. Severity of common post TBI symptoms [1 to 30 days post traumatic brain injury event]

      The severity of the five most common post TBI symptoms, including headache, nausea, sleep disturbance, poor concentration and forgetfulness/poor memory as measured by the scores of individual questions in the Rivermeade Post-concussion Questionnaire within 24 hours of admission, post injury day 7, and post injury day 30. Scale is 0 to 64

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HonorHealth John C. Lincoln Medical Center Phoenix Arizona United States 85020
    2 HonorHealth Deer Valley Medical Center Phoenix Arizona United States 85027

    Sponsors and Collaborators

    • HonorHealth Research Institute

    Investigators

    • Principal Investigator: Ryab mcPherson, DO, HonorHealth Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HonorHealth Research Institute
    ClinicalTrials.gov Identifier:
    NCT04291066
    Other Study ID Numbers:
    • 1445221
    First Posted:
    Mar 2, 2020
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Acetylcysteine
    N-monoacetylcystine

    Study Results

    No Results Posted as of Sep 1, 2021