Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209548995270 Date of Approval: 22/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of N-Acetylcysteine on moderate to severe traumatic brain injury patients
Official scientific title Effect of N-Acetylcysteine on moderate to severe traumatic brain injury patients
Brief summary describing the background and objectives of the trial Background: N-acetylcysteine (NAC) is a sulfhydryl-containing compound with antioxidant, anti-inflammatory, and mucolytic properties, as well as enhancing GSH S-transferase activity, repleting GSH, scavenging free radicals, and stabilizing protein structures by crosslinking cysteine disulfide molecules. NAC can reduce the oxidative impact of reactive oxygen species. NAC has been repurposed as an adjuvant treatment for TBI due to its antioxidant and anti-inflammatory effects, which might be useful in TBI therapy. Research objectives : Assessment of the effect of NAC on blood levels of S100B and NSE as markers of neuronal damage and prognosis, MDA as a marker of oxidative stress and prognosis, and IL-6 as a marker of inflammation and prognosis in patients with moderate to severe TBI admitted to the intensive care unit (ICU).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2022
Actual trial start date
Anticipated date of last follow up 01/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NAC 7 days NAC group will receive the following regimen based on the dose used by Hoffer et al(15). Orally: Loading dose of 4 gm followed by 2 gm every 12 hours for 4 days followed by 1.5 grams every 12 hours for 3 days. 20
Control Group No Drug 7 days No comparative drug was given to control group. 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Males or Females from 18 to 90 Years. 2. Hospital admission in the first 24 h of injury. 3. Moderate to severe traumatic brain injury (GCS score ≤ 12) 4. The ability to tolerate enteral feeding. 5. Consenting guardian / relative. 1. Pregnant and breast-feeding women 2. Late presentation to hospital >24 hours. 3. Pre-existing hepatic failure. 4. Pre-existing renal failure. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/10/2021 Ethics committee Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Alexandria University, 17 Champollion Street, El Messalah, Alexandria, Egypt. Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Difference between the two groups in NSE levels on day 7 day 7
Secondary Outcome • Difference between the two groups in S100B levels on day 7 • Difference between the two groups in MDA levels on day 7 • Difference between the two groups in IL-6 levels on day 7 • Glasgow coma scale (GCS) day 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria main university hospital Al Mothaf, Al Mesallah Sharq, Al Attarin, Alexandria Governorate 5372066 Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alaa Refaat Gouda Moharram bek Alexandria Egypt Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Pharmacy Damanhour University El Gomhouria Street, Damanhour, Beheira Governorate, Egypt. Damanhour Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faculty of Medicine Alexandria University Faculty of Medicine Alexandria University, 17 Champollion Street, El Messalah, Alexandria, Egypt. Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Gouda gs-alaa.gouda@alexu.edu.eg +201069235436 El Gomhouria Street, Damanhour, Beheira Governorate, Egypt.
City Postal code Country Position/Affiliation
Alexandria Egypt Department of Clinical Pharmacy Faculty of pharmacy Damanhour University.
Role Name Email Phone Street address
Public Enquiries Alaa Gouda gs-alaa.gouda@alexu.edu.eg +201069235436 El Gomhouria Street, Damanhour, Beheira Governorate, Egypt.
City Postal code Country Position/Affiliation
Damanhour Egypt Department of Clinical Pharmacy Faculty of pharmacy Damanhour University.
Role Name Email Phone Street address
Scientific Enquiries Alaa Gouda gs-alaa.gouda@alexu.edu.eg +201069235436 El Gomhouria Street, Damanhour, Beheira Governorate, Egypt.
City Postal code Country Position/Affiliation
Damanhour Egypt Department of Clinical Pharmacy Faculty of pharmacy Damanhour University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: Data underlying results. Informed Consent Form Time Frame: Starting 6 months after publication. Access Criteria: Controlled access to data. Requests are made to the PI. Requests are reviewed and answered by the PI. Data will be provided through E-mail.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information