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

H

HonorHealth Research Institute

Status and phase

Completed
Phase 2

Conditions

Traumatic Brain Injury

Treatments

Drug: N-Acetyl cysteine

Study type

Interventional

Funder types

Other

Identifiers

NCT04291066
1445221

Details and patient eligibility

About

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.

Full 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).

Enrollment

92 patients

Sex

All

Ages

60 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

92 participants in 2 patient groups

Treatment
Experimental group
Description:
oral N-acetyl cysteine and oral multivitamin tablets
Treatment:
Drug: N-Acetyl cysteine
Non-Treatment
No Intervention group
Description:
Routine Care

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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