Determination of the Effect of Oral Simvastatin on the Outcome of Patients with Severe Traumatic Traumatic injury of the Brain
Design
Patients who are eligible for inclusion criteria are randomly assigned to two groups of 49, which are in addition to daily supplemented therapies for oral simvastatin with a daily dose of 40 mg for 10 days. Another group, in addition to supportive care that has been done so far, is divided into placebo (lactose tablets).How to randomize using randomized code by computer software Assigning patients to groups one and two is done by a researcher who is not aware of the treatment groups. The phase of this study is three.
Settings and conduct
All patients with severe traumatic brain injury who go to Imam Hospital emergency department and have the entry criteria enter this clinical trial study.
Participants/Inclusion and exclusion criteria
Patients with severe brain injury with GCS = 8 and below at the time of referral to the emergency room that have CT scan of hematoma or spastic lesions (except fx) and who are not candidates for surgery and between the ages of 18 and 60 years
Intervention groups
98 patients with traumatic brain damage are included in this study. 49 patients undergo supportive care for patients so far and 49 others are treated with simvastatin in addition to the above.
The effect of oral simvastatin on the outcome of patients with severe traumatic brain injury
Public title
The effect of oral simvastatin on the outcome of patients with severe traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe traumatic brain injury
Non-use of corticosteroids and statins and NSAIDs
Not having an allergy to statins
Not having a history of autoimmune, cardio, respiratory, neuromuscular, liver or kidney disease
Exclusion criteria:
Space-occupying lesion in the skull, including hematoma and ...
GCS higher than 8 or GCS = 3 on admission
Age> 60 and <18 years
Syndrome organ trauma that requires surgical intervention.
trauma of the limbs that requires surgical intervention.
History of poisoning or drug use
sepsis during the first 72 hours of admission
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the method of randomization and sequencing is simple and randomization software, and how it is sequenced in the same way, and the assigned group is not known before the assignment of the individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this plan, the main physician and the doctors of this article, as well as the patients involved in this project, health care units and nurses, data analyzers and authors of the article, the safety committee and data monitoring, are double blind. And the doctor who blinds and monitors and collects is aware of the subject.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mazandaran University of Medical Sciences
Street address
Imam Hospital, Razi Ave, Sari Town
City
Sari
Province
Mazandaran
Postal code
48166-33131
Approval date
2018-10-07, 1397/07/15
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.3165
Health conditions studied
1
Description of health condition studied
Severe traumatic brain injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
GCS, APACHEE2, ISS
Timepoint
The beginning of the study, Day 3 and Day 10 after starting treatment
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In addition to supportive therapies, daily treatment with simvastatin will be administered at a dose of 40 mg per day for 10 days.
Category
Treatment - Drugs
2
Description
Control group: In addition to the therapies that have been done so far, they will be placed under the placebo (lactose tablet).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hospital
Full name of responsible person
Sajad Shafiei
Street address
Imam hospital, Razi Ave, Sari town
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Email
sajad.shafiee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sajad Shafiei
Street address
Imam hospital, Razi Ave, Sari Town
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Email
sajad.shafiee@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sajad Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Hospital, Razi Ave, Sari Town
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 113336700
Email
sajad.shafiee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sajad Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Hospital, Razi Ave, Sari Town
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Email
sajad.shafiee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sajad Shafiee
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Razi Ave, Imam hospital, Sari Town
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1630
Fax
Email
sshafiei@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available