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.: PACTR202112742845790 Date of Approval: 24/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized controlled clinical trial using alpha-tocopherol and ascorbic acid in the treatment of moderate traumatic brain injury
Official scientific title A randomized controlled clinical trial using alpha-tocopherol and ascorbic acid in the treatment of moderate traumatic brain injury
Brief summary describing the background and objectives of the trial Background: Traumatic brain injury (TBI) is a devastating and complex disease state that accounts for a staggering 40% of all deaths from acute injuries. Currently, TBI is a major public health concern and a leading cause of disability worldwide. Oxidative stress (OS) is a major pathophysiological hallmark of secondary damage in brain injury. Several pharmacological agents, including antioxidants have been tried in the treatment of acute traumatic brain injury with varying degrees of success. Some studies have shown remarkable therapeutic benefits using safe and cheap antioxidants- alpha-tocopherol and ascorbic acid- in the treatment of traumatic brain injury. Such studies are yet to be replicated in our locality. If these agents are found to be effective, they will go a long way in improving the outcome of this devastating disease. Objectives: 1. To determine the effects of ascorbic acid, alpha-tocopherol and a combination of both drugs on the mortality of patients with moderate TBI 2. To determine the effects of ascorbic acid, alpha-tocopherol and a combination of both drugs on the duration of hospitalization of patients with moderate TBI 3. To determine the effects of ascorbic acid, alpha-tocopherol and a combination of both drugs on the Glasgow outcome score of patients with moderate TBI 4. To study the demography of moderate TBI in JUTH with respect to age, gender distribution and aetiology
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/10/2017
Actual trial start date 01/10/2018
Anticipated date of last follow up 08/06/2020
Actual Last follow-up date 06/07/2020
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group alpha tocopherol group 2000IU orally 7days For the alpha-tocopherol group, 2000IU of alpha-tocopherol was administered via a nasogastric tube and flushed with 10mls of warm water. If the patient could swallow, 2000IU of alpha-tocopherol caplets was given to the patient to swallow 30
Experimental Group ascorbic acid group 10grams of IV ascorbic acid given on day one and 4grams IV given on days 4, 5, 6 and 7 5days Day 1: 10grams of IV ascorbic acid was dissolved in 500mls of normal saline and administered Days 4-7 4grams of IV ascorbic acid was dissolved in 500mls of normal saline and administered 30
Experimental Group Combination group 200IU of alpha tocopherol, 10grams of IV ascorbic acid on day 1 and 4grams of IV ascorbic acid on days 4 to 7 7days 200IU of alpha tocopherol daily from days 1 to 7, 10grams of IV ascorbic acid on day 1 and 4grams of IV ascorbic acid on days 4 to 7 30
Control Group Control group Standard treatment of head injury throughout admission Standard treatment of head injury without ascorbic acid or alpha tocopherol 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 16yrs and above 2. Moderate head injury (GCS: 9-12) 3. Acute phase of trauma at 72hours or less 4. Brain CT scan within 72hours of injury 1. Patients with space-occupying lesions requiring emergency evacuation 2. Patients with TBI duration greater than 72hrs 3. Patients with a previous history of craniotomy or any significant neurosurgical intervention 4. Patients with significant concomitant extracranial injuries 5. Patients with history of liver disease, renal disease or bleeding diathesis 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 100 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 11/04/2016 Jos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
JUTH Lamingo Jos PMB 2076 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glasgow outcome score, mortality and lenght of hospital stay At discharge, 3months and 6months post discharge
Secondary Outcome Demographics of head injury in adults presenting to Jos University Teaching Hospital Discharge from hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jos University Teaching Hospital Lamingo Road Jos Plateau State Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Jerry Philip Department of Surgery, Jos University Teaching Hospital Jos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jerry Philip Department of Surgery, Jos University Teaching Hospital Jos PMB 2076 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jerry Philip philipjerry222@gmail.com +447840835477 Department of Surgery, Jos university Teaching Hospital
City Postal code Country Position/Affiliation
Jos PMB 2076 Nigeria Neurosurgery clinical fellow
Role Name Email Phone Street address
Public Enquiries Kyesmen Nanpan nipan007@gmail.com +2348032107513 Department of Surgery, Jos University Teaching Hospital
City Postal code Country Position/Affiliation
Jos PMB 2076 Nigeria Neurosurgical Specialist Registrar
Role Name Email Phone Street address
Scientific Enquiries Gyang Bot gyangbot@yahoo.co.uk +2348146361304 Department of surgery, Jos University Teaching Hospital
City Postal code Country Position/Affiliation
Jos PMB 2076 Nigeria Neurosurgery Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Patients enrolled into the study were de-identified during the data collection. Hence, the data can be shared with the scientific community Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/12/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/12/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information