Does n-acetyl cysteine hasten return to normal brain function in patients who have concussive head injury?

A randomised double blind placebo control trial of the efficacy of oral N-acetyl Cysteine in mild traumatic brain injury patients presenting to a regional Emergency Department

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001371280

Acronym

NACCHI N-acetyl cysteine in concussive head injury

Enrollment

120

Registered

2018-08-15

Start date

2019-03-01

Completion date

2019-06-30

Last updated

2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Study is designed to show if NAC improves rate of recovery from minor traumatic brain injury in patient who present to a regional rural ED Intervention offered over and above standard care is trail drug (or placebo) powder to be reconstituted to an oral suspension. First dose is 4 gms given in the ED Subsequent dosing starts 18 to 24 hours following loading dose at 2gm twice daily for four days follwoed by 1.5 gm twice daily for 3 days

Interventions

Oral n-acetyl cysteine vs placebo 4 grams of reconstituted powdered drug or placebo as loading dose orally adminstered in the Emergency Department 2gms of same twice daily for four days (starting 18-24 hours post first dose) followed by 1.3gm of same for three days twice daily

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

17 Years to No maximum

Healthy volunteers

Inclusion criteria

>16 years old head injury or significant deceleration injury t o torso with at least one of the following Confusion or disorientation Loss of consciousness Post trauma amnesia other neurological abnormality - focal signs seizure intracranial lesion on CT

Exclusion criteria

moderate or severe TBI (GCS <13 on ED arrival, Post traumatic amnesia >24h) -need for hospital admission for any reason (due to the logistics of the study) -Not living independantly -Unable to take NAC for any reason -Non resident in the area/ not able to follow up at 7 days -Significant intoxication with alcohol or other drug (if patient is sober and able to provide informed consent at the time of discharge and otherwise meets study criteria, they are eligible for the study) -Known cognitive impairment

Outcome results