In this study we will investigate the effect of N-acetylcysteine(NAC) on mild traumatic brain injury(MTBI). In this randomized, double-blinded, placebo controlled- Phase III trial, randomizationof 104 patients with MTBI will be performedby random number tables. Initial diagnosis will be determined by the results of physical examination and CT scan. Inclusion criteria includes patients older than 18 years with MTBI and a score between 9–13 on the Glasgow Coma Scale(GCS). Patients are excluded who have consumed alcohol or used narcotics at anytime while diagnosed with MTBI. Patients who show an allergic reaction to NAC will also be excluded from the study. During the treatment, as part of the routine, the physician will assess the level of consciousness by checking eye pupils and GCS. Blood samples will be taken from patients and initial level of blood antioxidant enzymes (SOD, GPX) will be recorded in the checklist. An hour after admission, treatment group (52 patients) will receive infusion of NAC 150mg/kg in 200ml Glucose5% over a 30minute period. The control group (52 patients) will receive infusion of 200 cc serum distilled water 5% over a 30 minute period. Patients and the doctor who records the results were unaware of the form of interventions. Both treatment and placebo group will be re-sampled six hours after the first dose and the results will be recorded. If the investigated factors increase, response to treatment will be marked positive. It is estimated thata year and six months will be required for the completion of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010131709N1
Registration date:2017-03-05, 1395/12/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-05, 1395/12/15
Registrant information
Name
Ayat Ghasemi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6281
Email address
a.ghasemi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
In this study, the cost of drugs provided by Vice chancellor for research, Arak University of Medical Sciences.
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the effect of N-acetylcysteine (NAC) in patients with moderate traumatic brain injury (MTBI)
Public title
The effect of N-acetylcysteine (NAC) in patients with moderate traumatic brain injury (MTBI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years old.; patients with moderate traumatic brain injury; The GCS between 9 and 13; Filling out the informed consent form by the patient or the accompanies.
Exclusion criteria:
Unwillingness to participate in the study; Patients who have consumed alcohol or used narcotics at anytime while diagnosed with MTBI; Patients who showed an allergic reaction to NAC
Age
From 18 years old to 120 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Valiasr Hospital
City
Arak
Postal code
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
Ir.arakmu.rec.1395.97
Health conditions studied
1
Description of health condition studied
Traumatic brain injury
ICD-10 code
S06.1
ICD-10 code description
Traumatic cerebral oedema
Primary outcomes
1
Description
Superoxide dismutase
Timepoint
Before treatment, six hours after the first dose
Method of measurement
Blood samples will be taken from patients and initial values of blood antioxidant enzymes: (Superoxide dismutase U/ml ) will be recorded in the checklist.
2
Description
Glutathione peroxidase
Timepoint
Before treatment, six hours after the first dose
Method of measurement
Blood samples will be taken from patients and initial values of blood antioxidant enzymes: (Glutathione peroxidase U/l ) will be recorded in the checklist.
Secondary outcomes
empty
Intervention groups
1
Description
The treatment group : Patients will receive N-acetylcysteine ( NAC) 150mg/kg in 200ml Glucose5% over a 30 minute time period.
Category
Treatment - Drugs
2
Description
The control group: Patients will receive 200 cc serum distilled water 5% over a 30 minute time period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Ayat Ghasemi
Street address
Valiasr Hospital, ValiAsr Square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Hasan Haherahmadi
Street address
Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Gharibi
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Valiasr Hospital, ValiAsr Square, Arak
City
Arak
Postal code
Phone
+98 912 633 0676
Fax
Email
morteza.qaribi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ghasemi
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Valiasr Hospital, ValiAsr Square, Arak
City
Arak
Postal code
Phone
+98 916 661 7053
Fax
Email
A.ghasemi@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ghasemi
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Valiasr Hospital, ValiAsr Square, Arak
City
Arak
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)