Determination of the Effect of Propranolol on the Prognosis of Traumatic Brain Injury
Design
Recruited patients will be divided into treatment and control group through simple randomization technique. This study is double blind and attending physician and patients are blind to treatment protocols .The patients in treatment group will be administered 20 mg propranolol, oral, twice a day. The control group will receive no intervention. Given a 95% confidence level, 80% power and a 10% attrition rate at least 110 samples are required.
Settings and conduct
In this study 110 patients admitted to Shahid Rajaee Trauma Center of Shiraz University Hospital with severe traumatic brain injury will prospectively be recruited. These patients will be divided into treatment and control group through simple randomization technique. This study will be double blind in which physician and patients are blind to treatment protocols.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age >18 years, blunt injury mechanism and admission to neurosurgical intensive care unit (NICU). Exclusion criteria: Early deaths (stay less<48 hours), patients prescribed beta-blocker therapy pre-admission and those suffering any extracranial injuries requiring invasive interventions or surgery
Intervention groups
The patients in treatment group will be administered 20 mg propranolol, oral, twice a day. The control group will receive no intervention.
Main outcome variables
Glasgow Outcome Score Extended (GOS-E)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130310012776N4
Registration date:2018-08-02, 1397/05/11
Registration timing:registered_while_recruiting
Last update:2018-08-02, 1397/05/11
Update count:0
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Hosseinali Khalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3625 4206
Email address
khalili_h@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Propranolol on the Prognosis of Traumatic Brain Injury (TBI)
Public title
effect of Propranolol in Traumatic Brain Injury (TBI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age >18 years
blunt brain injury mechanism
admission to neurosurgical intensive care unit (NICU)
Exclusion criteria:
patients were prescribed regular beta-blocker therapy pre-admission
those suffering any extracranial injuries requiring invasive interventions or surgery
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with randomizer software
Blinding (investigator's opinion)
Double blinded
Blinding description
ICU patients and attending Physician are unaware of treatment group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
6th Floor,Central building of Shiraz University of Medical Sciences, Zand St
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.SUMS.REC.1396.133
Health conditions studied
1
Description of health condition studied
TBI
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Glasgow Outcome Score Extended (GOS-E)
Timepoint
6 months
Method of measurement
clinical exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 mg propranolol every 8 hours for 10 days.
Category
Treatment - Drugs
2
Description
control group: no drug use
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Hosseinali Khalili
Street address
Rajaee Hospital, Chamran Blvd
City
shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3624 8980
Email
khalili_h@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hosseinali Khalili
Street address
Central Building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3624 8980
Email
khalili_h@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hosseinali Khalili
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Rajaee Hospital, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3624 8980
Fax
+98 71 3624 8980
Email
khalili_h@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hossein Ali Khalili
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Rajaee Hospital, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
khalili_h@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hossein Ali Khalili
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Rajaee Hospital, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
khalili_h@sums.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