A clinical trial of effects of oral glibenclamide on size of brain contusions and their peripheral edema in patients with moderate and severe traumatic brain injury
Objective: The aim of this study is to determine the effects of oral glibenclamide on size of brain contusions and their peripheral edema in patients with moderate and severe traumatic brain injury
Design
Study design: Randomized double-blind placebo-controlled clinical trial.Patients will be randomly assigned to 2 study groups with a 1-to-1 ratio using a computerized random digit generator utilizing the admission number of the patients. Randomization will be done by the use of computer software
Settings and conduct
Among patinets referred to Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged between 18 and 75 years with documented closed head injury, non-penetrating brain injury, having brain contusions on initial brain CT scan, GCS: 5-13 without influence of sedations upon admission.
Exclusion criteria: Patients with spinal cord injury or spinal column instability with neurologic deficit, patients with INR>1.6, systolic BP less than 90 mmHg on admission without respond to fluid resuscitation, Pregnant women or a positive pregnancy test or those who intend to breastfeed during study days.
Intervention groups
Intervention group: Oral glibenclamide 15 mg (three tablet, 5 mg each, chemidarou Pharmaceutical Company), daily for 10 days. Control group: Placebo agent (Barij Essence Pharmaceutical Company, 3 tablets Daily, for 10 days
Main outcome variables
Primary outcome: Brain contusion volume determined by CT-volumetry. Secondary outcome: precontusional edema volume and Glasgow Outcome Scale (GOS).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N45
Registration date:2019-01-21, 1397/11/01
Registration timing:registered_while_recruiting
Last update:2019-01-21, 1397/11/01
Update count:0
Registration date
2019-01-21, 1397/11/01
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of effects of oral glibenclamide on size of brain contusions and their peripheral edema in patients with moderate and severe traumatic brain injury
Public title
The effects of oral glibenclamide in patients with traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients aged between 18 and 75 years with documented closed head injury
patients with non-penetrating brain injury
Having brain contusions on initial brain CT scan
GCS: 5-13 without influence of sedations upon admission
Random blood sugar more than 70 mg/dl before the intervention
Patients without a lesion on brain CT which urges a surgical evacuation at any time of hospital admission (Surgical EDH, SDH, ICH or midline shift>5mm and decompressive craniectomy)
Patients without severe renal disorder from past history or Cr>2.5
Patients without severe liver disease from past history or total bilirubin above 1.5 times of normal value.
Exclusion criteria:
Exclusion criteria: Patients with spinal cord injury or spinal column instability with neurologic deficit.
Patients with INR>1.6
Systolic BP less than 90 mmHg on admission without respond to fluid resuscitation.
Pregnant women or a positive pregnancy test or those who intend to breastfeed during study days
Usage of warfarin, heparin, clopidogrel, LMWH within 72 hours prior to traumatic event
Usage of glibenclamide 72 hours prior to traumatic event
Patients with PaO2<60 mmHg
Patients with diabetes mellitus on either oral hypoglycemic agents or insulin before TBI
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to 2 study groups with a 1-to-1 ratio using a computerized random digit generator utilizing the admission number of the patients. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation concealment will be done by having procedure indicator cards inside a set of numbered opaque sealed envelopes. Patients will be allocated to treatment groups, after screening. None of the staff or patients will have access to the randomization codes during the study. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.066
Health conditions studied
1
Description of health condition studied
Brain contusion
ICD-10 code
S06.3
ICD-10 code description
Focal traumatic brain injury
Primary outcomes
1
Description
Brain contusion volume
Timepoint
On admission, day 3 and 7 days after intervention
Method of measurement
CT-volumetry of brain contusions
Secondary outcomes
1
Description
precontusional edema volume
Timepoint
On admission, day 3 and 7 days after intervention
Method of measurement
CT-volumetry of brain contusions
2
Description
Glasgow Outcome Scale (GOS)
Timepoint
On Discharge time and 3 months later
Method of measurement
Physical Examination
Intervention groups
1
Description
Intervention group: Oral glibenclamide 15 mg (three tablet, 5 mg each, chemidarou Pharmaceutical Company), daily for 10 days
Category
Treatment - Drugs
2
Description
Control group: Placebo agent (Barij Essence Pharmaceutical Company, 3 tablets Daily, for 10 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Esmaeil Fakharian
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
fakharian_e@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
Banafsheh.hr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Sajad Yazdani
Position
Resident of Neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
yazdanisajad.hamed@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Esmaeil Fakharian
Position
Professor of Neurosurgery
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
fakharian_e@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Sajad Yazdani
Position
Resident of Neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
yazdanisajad.hamed@gmail.com
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