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Evaluation of the effect of glibenclamide on improving the treatment results and consciousness of patients with traumatic brain diffuse axonal injury

Protocol summary

Study aim
we examined the effect of this drug on three months GOS after TBI.
Design
Clinical trial, prospective, with two groups of case and control, double-blind, randomized, on 96 patients. Excel random function was used for randomization.
Settings and conduct
The drug or placebo was injected by the nurse. GCS was measured at discharge. Patients were referred to Ahvaz Golestan Hospital as outpatients after three months and GOS was measured after three months. The study was performed blindly.
Participants/Inclusion and exclusion criteria
All TBI patients with moderate(9-12)to severe(4-8) GCS referred to the emergency department of Golestan Hospital in Ahvaz with a maximum of 24 hours after TBI were included in study. Patients with a history of other diseases and those who needed other therapeutic and pharmacological interventions were excluded from the study.
Intervention groups
Patients were randomly divided into one of two case group receiving 10 mg of glibenclamide daily for 10 days or the control group receiving placebo with the same dose for 10 days.
Main outcome variables
GCS, GOS, length of stay in ICU, mortality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200815048418N1
Registration date: 2020-12-12, 1399/09/22
Registration timing: retrospective

Last update: 2020-12-12, 1399/09/22
Update count: 0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
hesam rasoulian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 2576
Email address
hr9473.hr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-18, 1397/11/29
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
2019-03-06, 1397/12/15
Actual recruitment end date
2019-06-21, 1398/03/31
Trial completion date
2019-06-21, 1398/03/31
Scientific title
Evaluation of the effect of glibenclamide on improving the treatment results and consciousness of patients with traumatic brain diffuse axonal injury
Public title
Evaluation of the effect of glibenclamide in patients with traumatic diffuse brain injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All TBI patients with moderate(9-12)to severe(4-8) GCS referred to the emergency department of Golestan Hospital in Ahvaz with a maximum of 24 hours after TBI.
Exclusion criteria:
Patients with diabetes mellitus, patients that required surgery, spinal cord injury, patients with any known history of renal or hepatic diseases, patients with past medical history of brain tumors, blood glucose <50 g/dL or >500 mg/dL on admission; internal organs diseases, penetrating brain injury, creatinine >2.5mg/dL or on hemodialysis, total bilirubin >1.5 times of normal value, infections, or previous craniotomy; pregnant patients or patients who intended to breastfeed after being discharged; patients with international normalized ratio >1.5 or use of antiplatelets or anti coagulants within 7 days before admission, history of glucose-6-phosphate dehydrogenase deficiency or any diagnosed allergy to sulfonylurea; patients with contusions in brainstem or an systolic blood pressure <90 mm Hg without response to fluid resuscitation; and patients with contraindications to oral route for taking the medication or treatment with other investigational agents during hospitalization.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 96
Actual sample size reached: 64
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, all patients during the study period will be equally and randomly divided into case and control groups and will enter the study. Randomization of study samples will be done in two groups by random allocation. For this purpose, we first determine the total sample size, then randomly assign a set of them to group A and the rest to group B. we do this using a table of random numbers. In assigning patients to two hidden groups Random sequencing will be considered throughout the process and the patient and researcher will not be aware of the group the patient is entering. Awareness of subsequent allocation may lead to the elimination of specific patients by the researcher based on their disease prognosis, or patients with better conditions enter the intervention group and patients with worse conditions enter the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants were kept blind to being in the intervention group or control group. Patients were assured that their information would be kept strictly confidential. Patients were given full explanations about the objectives, method of implementation of the plan and its possible side effects, and if they or their legal guardians were willing, consent was obtained and included in the study. They were blind from being in any of intervention or control groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur university of medical sciences
Street address
Esfand Ave, Farvardin Blvd, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-02-16, 1397/11/27
Ethics committee reference number
IR.AJUMS.REC.1397.854

Health conditions studied

1

Description of health condition studied
traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury

Primary outcomes

1

Description
Glasgow outcome scale
Timepoint
Three months after TBI
Method of measurement
Glasgow outcome scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: daily 10 mg glibenclamide for 10 days.
Category
Treatment - Drugs

2

Description
Control group: placebo Prescription
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Hesam Rasoulian
Street address
Golestan hospital, Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
Golestanjpsital@yahoo.com
Web page address
https://hgolestan.ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Esfand street
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311 4155
Email
info@ajums.ac.ir
Web page address
https://ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hesam Rasoulian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Esfand street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
009833114155
Email
hr9473.hr@gmail.com
Web page address
https://ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hesam Rasoulian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Esfand street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4155
Email
hr9473.hr@gmail.com
Web page address
https://ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hesam Rasoulian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Esfand street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4155
Email
info@ajums.ac.ir
Web page address
https://ajums.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
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