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.: PACTR201708002405365 Date of Approval: 06/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of simvastatin in treating patients with traumatic brain injury.
Official scientific title Efficacy of simvastatin in treating patients with traumatic brain injury.
Brief summary describing the background and objectives of the trial This study was was done to determine whether the administration of simvastatin after acute Traumatic brain injury has neuroprotective effect as determined by functional outcome and survival. Also, to know whether simvastatin administration within the first 24 hours of Traumatic brain injury could influence plasma level of Amyloid precursor protein . Study objectives The primary outcome measure was Glasgow Coma Scale level and plasma level of Amyloid precursor protein . While, the secondary outcome measure included APACHE II score, ICU mortality and Glasgow outcome Scale .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,traumatic brain injury
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2015
Actual trial start date 10/05/2015
Anticipated date of last follow up 01/05/2016
Actual Last follow-up date 01/06/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL not yet
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo for 7 days. recieve placebo 20 Placebo
Experimental Group simvastatin 80 mg then 40 mg 7 days drug 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
acute Traumatic brain injury age range from 18 to 60 years admitted to Intensive care unit within 24 hours history of allergy to statins myopathies patients with major organ dysfunction (renal, liver, cardiovascular) drug or alcohol abuse pregnancy or lactation life threatening multiple trauma administration of fibrates, niacin, or corticosteroid drugs psychiatric disorder past history of neurological illness, prolonged Q-T interval expected to die imminently (< 24 hours) signs of brain stem failure. 18 Year(s) 60 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 11/03/2015 ethical committee of faculty of medicine of El Minia university hospital
Ethics Committee Address
Street address City Postal code Country
General street El minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glasgow Coma Scale level and plasma level of Amyloid precursor protein . on admission, 1 hour, 12 hour, 24 hour, 48 hours, then every day till 7th day at admission, 3rd and 5th day
Secondary Outcome APACHE II score, Intensive care unit mortality and Glasgow outcome scale at admission and at discharge during the period of ICU stay at discharge from the hospital and at 3 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elminia university hospital El Corniche street Elminia 611111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine general street El minia 61519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine El minia university General street El Minia 61519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr Nagy Sayed Ali El Gomhoria Maghagha 16691 Egypt
Mokhtar Mostafa Mahran Borsayed El Edwa 61694 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abeer Hassanin abeerhassanine@yahoo.com 00201004234010 82 El Seka Elhadid street
City Postal code Country Position/Affiliation
Elminia Egypt Assisstant professor of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Abeer Hassanin abeerhassanine@yahoo.com 00201004234010 82 El Seka Elhadid street
City Postal code Country Position/Affiliation
Elminia Egypt Assisstant professor of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Abeer Hassanin abeerhassanine@yahoo.com 00201004234010 82 El Seka Elhadid street
City Postal code Country Position/Affiliation
Elminia Egypt Assisstant professor of anesthesia and ICU
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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