Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001371280p
Ethics application status
Not yet submitted
Date submitted
6/08/2018
Date registered
15/08/2018
Date last updated
7/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does n-acetyl cysteine hasten return to normal brain function in patients who have concussive head injury?
Scientific title

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
Secondary ID [1] 295751 0
none
Universal Trial Number (UTN)
U1111-1218-6361
Trial acronym
NACCHI N-acetyl cysteine in concussive head injury
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild traumatic brain injury 309149 0
Condition category
Condition code
Injuries and Accidents 308033 308033 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 312078 0
Treatment: Drugs
Comparator / control treatment
Placebo powdered lemon flavoured inactive microcellulose powder
Control group
Placebo

Outcomes
Primary outcome [1] 307021 0
Proportion of patients who are symptom free at one week
Self reported
Do you feel as good as you did prior to injury with repsect to the following?
Headache Y/N
nausea Y/N
Balance Y/N
Difficulty with thinking or remebering Y/N
Emotional symptoms (irritability, lethargy, mood) Y/N
Timepoint [1] 307021 0
One week post injury
Secondary outcome [1] 350654 0
Objective tool- Tablet based Braincheck neurocognitive 'game'
Timepoint [1] 350654 0
One week
Secondary outcome [2] 350655 0
Proportion of patients symptom free at one month
Self reported
Do you feel as good as you did prior to injury with repsect to the following?
Headache Y/N
nausea Y/N
Balance Y/N
Difficulty with thinking or remembering Y/N
Emotional symptoms (irritability, lethargy, mood) Y/N
Timepoint [2] 350655 0
One month

Eligibility
Key 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
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinded sealed numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation from book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
Date of last participant enrolment
Anticipated
30/06/2019
Actual
Date of last data collection
Anticipated
31/07/2019
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 20731 0
New Zealand
State/province [1] 20731 0
Tasman/Nelson

Funding & Sponsors
Funding source category [1] 300342 0
Hospital
Name [1] 300342 0
NMDHB
Country [1] 300342 0
New Zealand
Primary sponsor type
Hospital
Name
NMDHB
Address
Nelson Marlborough District Health Board
Private Bag 18, Nelson 7042, New Zealand.
Country
New Zealand
Secondary sponsor category [1] 299781 0
None
Name [1] 299781 0
Address [1] 299781 0
Country [1] 299781 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301157 0
NZ HDC Southern Region Ethics Committee NZ
Ethics committee address [1] 301157 0
Postal address: C/o HDC
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 301157 0
New Zealand
Date submitted for ethics approval [1] 301157 0
20/08/2018
Approval date [1] 301157 0
Ethics approval number [1] 301157 0

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86038 0
Dr Tom Jerram
Address 86038 0
C/o Emergency Department
Nelson Hospital
Private bag 18 Nelson
NZ 7042
Country 86038 0
New Zealand
Phone 86038 0
+64272465554
Fax 86038 0
Email 86038 0
[email protected]
Contact person for public queries
Name 86039 0
Dr Tom Jerram
Address 86039 0
C/o Emergency Department
Nelson Hospital
Private bag 18 Nelson
NZ 7042
Country 86039 0
New Zealand
Phone 86039 0
+64272465554
Fax 86039 0
Email 86039 0
[email protected]
Contact person for scientific queries
Name 86040 0
Dr Tom Jerram
Address 86040 0
C/o Emergency Department
Nelson Hospital
Private bag 18 Nelson
NZ 7042
Country 86040 0
New Zealand
Phone 86040 0
+64272465554
Fax 86040 0
Email 86040 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.