Effects of oral glibenclamide on reduction of size of brain contusions and peri contusional edema and prognosis of patients with moderate and severe traumatic brain injury: a randomized clinical trial
The aim of the current study is to determine effects of oral Glibenclamide in moderate and severe TBI and its role in reduction of size of contusions and pericontusional edema. For this purpose we will include 104 patients with morerate and severe traumatic brain injury (TBI) between 18 to 75 years within 10-hours of injury. Those undergoing surgical evacuation of the hematoma, spinal cord injury and coagulopathy would be excluded from the study. The patients would be assigned to two study groups to receive oral glibenclamide in a dosage of 10mg daily for 10 days or placebo. The Glascow Outcome Scale (GOS) and GOSE and Disability Rating scale (DRS) would be assessed after 1, 3 and 6 months of injury. The brain contusion volume and edema would be measured on admission, 3rd day and 10th day after the intervention. Clinical scales and size of contusions and pericontusional edema will be compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121720353N1
Registration date:2015-05-15, 1394/02/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-15, 1394/02/25
Registrant information
Name
Nima Derakhshan
Name of organization / entity
Neurosurgery Department, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4259
Email address
derakhshn@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of oral glibenclamide on reduction of size of brain contusions and peri contusional edema and prognosis of patients with moderate and severe traumatic brain injury: a randomized clinical trial
Public title
Effects of oral glibenclamide in patients with traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Documented closed head injury; Age between 18 and 75 years; Having brain contusions on initial brain CT scan; Taking the first dosage of medication within first 10 hours of trauma event; GCS:5-13 without influence of sedations upon admission; Obtaining written informed consent from legally authorized representative
Exclusion criteria: Having 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); Spinal cord injury or spinal column instability with neurologic deficit; Penetrating brain injury; Any blood glucose under 50mg/dL or over 500mg/d; Severe renal disorder from past history or Cr>2.5 or patients on hemodialysis; Severe liver disease from past history or total bilirubin above 1.5 times of normal value; INR>1.6; Systolic BP below 90mmHg on admission without respond to fluid resuscitation; Pregnant women or a positive pregnancy test or those who intend to breastfeed during study days; Associated severe non-survivable injury; History of previous brain problems (Tumor, infections, strokes, …); Usage of warfarin, heparin, clopidogrel, LMWH within 72 hours prior to traumatic event
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
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
Shiraz University of Medical Sciences
Street address
Zand Avenue
City
Shiraz
Postal code
Approval date
2015-01-25, 1393/11/05
Ethics committee reference number
93-0101-7757
Health conditions studied
1
Description of health condition studied
Brain contusion
ICD-10 code
S06.3
ICD-10 code description
Focal brain injury
Primary outcomes
1
Description
Brain contusion and precontusional edema volume
Timepoint
Onadmission, day 3 and 10 after intervention
Method of measurement
CT-volumetry of brain contusions
2
Description
Outcome
Timepoint
6 months after intervention
Method of measurement
Glasgow Outcome Scale (GOS)
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: Oral glibenclamide 10 mg daily for 10 days
Category
Treatment - Drugs
2
Description
Group 2 : Placebo agent, 10mg Daily, for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei hospital
Full name of responsible person
Nima Derakhshan
Street address
Chamran Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Masoum Masoumpoor
Street address
Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nima Derakhshan
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Neurosurgery department office, Namzi hospital, Namazi square
City
Shiraz
Postal code
Phone
+98 71 3647 4259
Fax
+98 71 3647 4259
Email
derakhshn@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
Hosseinali Khalili
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Rajaei Hospital, Chamran Avenue,
City
Shiraz
Postal code
Phone
+98 71 3636 4001
Fax
Email
khalilih16@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nima Derakhshan
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Department of Neurosurgery Office, Namazi hospital, Namazi square
City
Shiraz
Postal code
Phone
+98 71 3647 4259
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)