Protocol summary

Summary
Traumatic brain injury (TBI) is one of the most common and financially devastating health problems in our society. There are an estimated 1.5 million cases of TBI annually in the United States, with at least 235,000 resultant hospitalizations and approximately 50,000 fatalities per year.1 More than 5 million persons in the United States are TBI survivors. Once the acute care period has ended, many TBI patients are left with motor, cognitive, or emotional dysfunction as a result of their injury.2 Although several therapies have shown benefit in preclinical models, there has been a notable failure of clinical translation, with a large number of late phase II and III trials failing to confirm benefit in human subjects. Thus, the treatment of TBI remains largely supportive, directed toward management of cerebral edema and intracranial hypertension via temporizing measures, such as administration of osmotic agents, hyperventilation, and ventricular drainage.3 None of these interventions have been definitively demonstrated to improve long-term functional outcome.4 The failure of preclinical therapies to translate into clinical benefit may derive from the heterogeneity of TBI pathology, which includes diffuse axonal injury, cerebral contusion, intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), and extraparenchymal hemorrhage. These primary insults are exacerbated by a secondary neuroinflammatory cascade of cerebral hypoperfusion and ischemia, oxidative stress, cerebral edema, and intracranial hypertension. The 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors, also known as “statins,” are an ideal candidate therapy for acute brain injury. Statins influence multiple mechanisms of acute and secondary neuronal injury; they have endothelial and vasoactive properties, as well as anti-oxidant, anti-inflammatory, anti-excitotoxicity, and anti-thrombotic effects. Statin treatment would be practical to implement in TBI because statins have wide availability, Food and Drug Administration approval, a favorable adverse event profile, and a track record of safety in critically ill populations.Preclinical data supports the benefit of statins in many of these disease processes include brain ischemia ,intracranial hemorrhage, SAH.clinical trials clearly show a benefit of statins in Ischemic stroke, SAH, TBI, alzaimeres pateints. This study investigated the effects of simvastatin in moderate traumatic brain injury to improve GCS,GOS and protection of formation of delayed brain contusion , delayed ischemic lesions and decrease time of hematoma resorption,mortality complication like DVT,Pneumonia. In this study, patients in the randomized groups are divided into (A&B) ( Simvastatin and placebo), study done constantly and visited patients on days 1, 3 and 10, discharge time, and at months 1, 3 and 6 the information collected. Patients with a factor of between 8-12 GCS and patients GCS less than 8 and greater than 12 are excluded. Simvastatin dose of 80 mg daily for ten days to patient data and weekly with alkaline phosphate for complication myositis check. The primary outcome include GCS on days 1, 3 and 10 and GOS on mount 1,3,6 Q

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109197597N1
Registration date: 2011-10-15, 1390/07/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-15, 1390/07/23
Registrant information
Name
Farhad Rahbarian yazdi
Name of organization / entity
Jundishapour medical university
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3032
Email address
rahbarian.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapour University of Medical Sciences
Expected recruitment start date
2011-01-23, 1389/11/03
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Simvostatin in moderate traumatic brain injury
Public title
Effect of Simvostatin in traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: patients with GCS 8-12 Exclusion: patients with GCS less 8 and more 12
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapour University of Medical Sciences
Street address
Ahvaz Jundishapour University of Medical Sciences
City
Ahwaz
Postal code
Approval date
2011-01-22, 1389/11/02
Ethics committee reference number
ETH-107

Health conditions studied

1

Description of health condition studied
Traumatic diffuse brain injury
ICD-10 code
S09.9
ICD-10 code description
Unspecified injury of head

Primary outcomes

1

Description
Glascow coma scale (GCS)
Timepoint
Day 1,3,10
Method of measurement
According to GCS score table

2

Description
Glascow outcome scale (GOS)
Timepoint
Mount 1,3,6
Method of measurement
According to GOS score table

Secondary outcomes

1

Description
Myositis
Timepoint
Every weekا alcalin phosphatase
Method of measurement
IU/L

Intervention groups

1

Description
Treatment with Simvastatin 80 mg daily for 10 days with screen Alkp weekly for drug side effect , accumulation of patients information include: GCS at admission and days 3 ,10 and CT scan finding include type and volume of lesions, ischemia and it`s changes , complications like DVT ,Pneumonia and after discharge GOS at mounts 1, 3 , 6 and CT scan finding.
Category
Treatment - Drugs

2

Description
For Placebo use a neuter substance like Simvastatin prepare by pharmacy ward administered for 10 days , accumulation of patients information include: GCS at admission and days 3 ,10 and CT scan finding include type and volume of lesions, ischemia and it`s changes , complications like DVT ,Pneumonia and after discharge GOS at mounts 1, 3 , 6 and CT scan finding.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahwaz golestan hospital
Full name of responsible person
Street address
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Alavi
Street address
Jundishapour Medical University Building ,Research Center
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Farhad Rahbarian
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Golestan village neurosurgery ward in Golestan hospital
City
Ahwaz
Postal code
Phone
+98 61 1374 3032
Fax
Email
rahbarian.f@ajums.ac.irdr.rahbarian@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Saleh Rasras
Position
Assistant proffesor
Other areas of specialty/work
Street address
Neurosurgery Ward
City
Ahwaz
Postal code
Phone
+98 916 118 5879
Fax
Email
dr.rasras@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Farhad Rahbarian Yazdi
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Golestan Hospital Neurosergery Ward
City
Ahwaz
Postal code
Phone
+98 61 1374 3032
Fax
+98 61 1374 3032
Email
rahbarian.f@ajums.ac.irdr.rahbarian@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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