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.: PACTR202009761063655 Date of Approval: 29/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Amantadine Sulphate versus magnesium sulfate on Traumatic Brain Injury.
Official scientific title Comparative Study between the Efficacy of Amantadine Sulphate versus magnesium sulfate on Traumatic Brain Injury. A prospective randomized trial
Brief summary describing the background and objectives of the trial Traumatic brain injury (TBI) occurs when a sudden trauma causes damage to the brain. Neuro-pharmacologic therapies are commonly used to enhance arousal and behavioral responsiveness, on the premise that injury‐induced derangements in dopaminergic and noradrenergic neurotransmitter systems can be improved through supplementation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/09/2020
Actual trial start date
Anticipated date of last follow up 02/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet 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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Magnesium group continuous infusion dose of 0.30 mmol/kg followed by an initial infusion of 0.05 mmol/kg/h. which will be achieved by lower target range of 1.0–1.85 mmol/L 5 days Patients will receive magnesium loading within 8 h of injury and followed by a continuous infusion dose of 0.30 mmol/kg followed by an initial infusion of 0.05 mmol/kg/h. which will be achieved by lower target range of 1.0–1.85 mmol/L 30 Active-Treatment of Control Group
Experimental Group Amantadine 100mg twice daily Intravenous (IV) 4 weeks Patients will receive Amantadine Sulphate in dose of 100mg twice daily Intravenous (IV) for 4 weeks. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients of both sex aged from (18-65 years) (GCS <_12) Refusal of patient guardians bleeding disorders severe pre-existing physical or mental disability severe co-morbidity that could interfere with the assessment of outcome, polytrauma patients pregnancy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 05/08/2020 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El Geish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Disability Rating Scale (DRS) will be collected at base line and weekly interval till first month then monthly till 6th month
Secondary Outcome Galsco Coma Scale will be collected at base line and at weekly interval till first month then monthly till 6th month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals El Geish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Tanta University EL Geish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dina Ahmed Ali El Malla El Geish Tanta 31527 Egypt
Mohammed Mohye Eldin Abu ELyazed El Geish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mohammed Abu Elyazed mohd_yazed75@yahoo.com +201120014472 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor of Anesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Principal Investigator Dina El Malla dr_dina90@yahoo.com 0020403317928 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Public Enquiries Ahmad Yossef ahmad.soliman@med.tanta.edu.eg +20403317928 ElGeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assistant professor of Neurosurgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1-Demographic data 2-Disability rating scale 3-Glasco Coma Scale 4-Length of hospital stay Study Protocol 2 years to those who request the data via the email of the= principal investigator according to the cause of request
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