Effect of deferoxamine injection on the Glasgow Outcome Scale in patients with severe traumatic brain injury: a double-blind, randomized controlled clinical trial
To determine the effect of deferoxamine on the Glasgow Outcome Scale in severe traumatic brain injury patients
Design
A single-center, concealed, randomized, blinded, controlled clinical trial with a parallel group design of 68 patients
Settings and conduct
This study will be conducted on 68 severe traumatic brain injury patients, admitted in the intensive care units of Emtiyaz (Rajaei) hospital (Shiraz University of Medical Sciences). Patients will be randomized into two groups and receive deferoxamine (intervention group: 20 mg/kg daily for seven consecutive days) and placebo (control group: same dose). All patients and physicians will be blinded to the patient groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: severe traumatic brain injury, and the age range of 18-65 years
Exclusion criteria: Glasgow Coma Scale score 3 or 4 upon admission; the presence of bilateral fixed dilated pupils; history of significant brain damage; anti-platelet and/or anti-clotting drugs use; history of blood and/or coagulation disorders; history of heart, kidney, liver, and hearing disorders; iron and /or prochlorperazine use; pregnant or breastfeeding individuals; history of cardiopulmonary arrest and resuscitation upon hospital arrival
Intervention groups
The intervention group will receive deferoxamine injection for 7 consecutive days as a 24-hour intravenous infusion. The control group will receive placebo drug for 7 consecutive days as a 24-hour intravenous infusion.
Main outcome variables
Assessment of Glasgow Outcome Scale scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220220054079N1
Registration date:2022-12-07, 1401/09/16
Registration timing:prospective
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Zahra Eghlidos
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3622 4078
Email address
eghlidos.zahra@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of deferoxamine injection on the Glasgow Outcome Scale in patients with severe traumatic brain injury: a double-blind, randomized controlled clinical trial
Public title
Deferoxamine in severe traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe traumatic brain injury
Patients with pure traumatic brain injury: having a score of less and equal to 3 on the Brain Abbreviated Injury scale; and a score of less than 3 on the Extracranial Abbreviated Injury scale
Exclusion criteria:
Allergy to deferoxamine mesylate
Serum creatinine more than 2 mg/dL
Hemoglobin less than 7 g/L, or patients requiring transfusion therapy
A Glasgow Coma Scale score of 3 or 4 with bilateral fixed and dilated pupils
A known history of intracranial diseases
A known history of thrombocytopenia (platelet count less than 50×109/L)
Concurrent use of anti‐coagulant or anti‐platelet agents or history of coagulation disorders (international normalized ratio more than 1.4)
Concurrent use of iron supplements or prochlorperazine
Impaired hearing
Pregnant or lactating women
History of cardiopulmonary arrest and resuscitation
Blood disorders (e.g. thalassemia, iron deficiency anemia)
GFR less than 50 ml/min
History of heart failure
History of liver disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
We will randomly divide eligible patients into two groups in a 1:1 ratio: intervention (group A) and control (group B). Block randomization will be performed with four patients in each block using an online randomization tool, and block sequences will be ABBA, AABB, BBAA, BABA, ABAB, and BAAB.
The principal researcher -who is not involved in patient evaluation and data analysis- will perform the randomization and conceal the allocation sequence from other investigators and patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The faculty of Pharmacy, Shiraz university of medical sciences, will prepare the placebo drug according to the intervention drug (same color, amount, and packaging). The study will be double-blind. For this purpose, the study drugs (deferoxamine and placebo) will be identically packed; the principal researcher will put number codes on the packages and he will keep these codes confidential. He will also perform the randomization but has no role in prescribing the drugs, as well as recording and analyzing the patients' information. Patients will be informed about the study's details and purpose, but they do not know which medication they will receive. So, patients, physicians, and analysts are blinded to treatment groups.
Placebo
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
Emtiyaz hospital, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7194815711
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.SUMS.REC.1400.760
Health conditions studied
1
Description of health condition studied
Severe traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Glasgow Outcome Scale
Timepoint
At the time of discharge, three and six months after the intervention
Method of measurement
Glasgow Outcome Scale
Secondary outcomes
1
Description
Duration of intensive care unit admission
Timepoint
From the admission date to discharge date from the intensive care unit
Method of measurement
Number of days
2
Description
Duration of hospital admission
Timepoint
From the admission date to discharge date from the hospital
Method of measurement
Number of days
Intervention groups
1
Description
Intervention group: severe traumatic brain injury patients receiving 20 mg/kg per day deferoxamine for 7 consecutive days and as a 24-hour intravenous infusion
Category
Treatment - Drugs
2
Description
Control group: receiving 20 mg/kg per day placebo drug for 7 consecutive days as and as a 24-hour intravenous infusion. The placebo is prepared by the faculty of Pharmacy, Shiraz university of medical sciences; it will be identical to the intervention drug in amount, shape, color, and packaging
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emtiyaz hospital, Chamran Blvd
Full name of responsible person
Hosseinali Khalili
Street address
Emtiyaz hospital, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
khalili_h@sums.sc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hosseinali Khalili
Street address
Emtiyaz hospital, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
khalili_h@sums.sc.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
40
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
2
Sponsor
Name of organization / entity
Afa Chemi Pharmaceutical Company
Full name of responsible person
Afsaneh Pasebani
Street address
No. 13, Navard St., Fath highway
City
Tehran
Province
Tehran
Postal code
1378756611
Phone
+98 21 6405 9000
Email
info@afachemi.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Afa Chemi Pharmaceutical Company
Proportion provided by this source
60
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Eghlidos
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Emtiyaz hospital, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
eghlidos.zahra@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Gholamreza Vadiee
Position
Neurourgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emtiyaz hospital, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
gholamrezavadiee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soodeh Jahangiri
Position
Postdoctoral researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Research Institute of Endocrine and Metabolism, Firoozeh St., Valiasr sq., Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۱۶۶۱۵
Phone
+98 21 2219 1411
Email
soudejahangiri@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