the aim of this study is to evaluate the effects of citicoline on the healing process of patients with severe TBI hospitalized in the ICU and neurosurgery departments of Imam Reza hospital in Birjand.
Design
This double-blind randomized clinical trial will perform on 30 patients. The patients will be randomly distributed into three groups.
Settings and conduct
This study is a clinical trial in patients aged 5 to 60 years with isolated and severe TBI (GCS less than or equal to 8) referred to ICU and Neurosurgery departments. Before the study, the goals and stages of the study will be fully explained to patients and informed oral consent will be obtained from patients who wish to participate in the study.
All patients will be randomly distributed into three groups of A, B or C by choosing one card from A, B or C cards. The study is a double-blind study in which only the physician is aware of the distribution of patients into three different groups, and patients, nurses, and researchers who collect all the data are unaware.
Participants/Inclusion and exclusion criteria
All patients with severe TBI with GCS lower or equal to 8 hospitalized in ICU and Neurosurgery ward with age between 5 to 60 years will be included in the study and patients with severe cognitive disorders, severe systemic disorder, those with penetrating skull trauma or open skull trauma, or severe chest or lung trauma, subdural or large epidural hematoma requiring surgery and pregnant women will be excluded.
Intervention groups
using IV Citicoline during hospitalization.
patients were randomly distributed into three groups of A (control), B (citicoline with a dosage of 0.5 gr/ twice a day) and C (citicoline with a dosage of 1.5 gr/ twice a day).
Main outcome variables
GCS; the degree of muscle strength; GOS; contusion volume and cerebral edema; patients' dependency on a ventilator; length of stay in ICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140611018063N7
Registration date:2020-03-21, 1399/01/02
Registration timing:retrospective
Last update:2020-03-21, 1399/01/02
Update count:0
Registration date
2020-03-21, 1399/01/02
Registrant information
Name
Ali Rajabpour Sanati
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1067
Email address
ali.poursanati@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research - Birjand University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-02-06, 1395/11/18
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2017-02-06, 1395/11/18
Trial completion date
2017-02-06, 1395/11/18
Scientific title
effects of citicoline on the healing process of patients with traumatic concussion
Public title
Effects of Citicoline in patients with traumatic concussion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic Head concussion
GCS lower or equal to 8
Hospitalized in ICU and Neurosurgery ward
Age between 5 to 60 years
Exclusion criteria:
severe cognitive disorders
severe systemic disorder
penetrating or open skull trauma
severe chest or lung trauma
subdural or large epidoral hematoma requiring surgery
younger than 5 or older than 60 years
pregnant women
Age
From 5 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
All the patients will be distributed randomly into three groups of A, B or C by randomly choosing one card marked with A, B or C out of 30 cards.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was a double-blind study, in which only the physician was aware of the distribution, and the patient, nurse, and researchers collecting information were unaware of the distribution into three groups. Access to the patient records will be prevented from the patient's nurse and the researches. Only the physician will be aware of patient records.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Birjand University of Medical Sciences
Street address
Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2016-03-12, 1394/12/22
Ethics committee reference number
IR.BUMS.Rec.1394.438
Health conditions studied
1
Description of health condition studied
head trauma
ICD-10 code
S06.2
ICD-10 code description
Diffuse brain injury
Primary outcomes
1
Description
level of consciousness in a patients
Timepoint
First 7 days and on 14th day of hospitalization
Method of measurement
Glasgow Coma Scale scoring system
2
Description
Muscle strength degree
Timepoint
The first week, on day 14, 21 and 30 of hospitalization
Method of measurement
Manual Muscle Testing scale
3
Description
Contusion volume and cerebral edema
Timepoint
Days 1, 3, 5 and 7
Method of measurement
Computed Tomography scans
4
Description
length of dependency on a ventilator
Timepoint
30 days of hospitalization
Method of measurement
Documentary Registry Data
5
Description
stay length in the intensive care unit
Timepoint
30 days of hospitalization
Method of measurement
Documentary Registry Data
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this groups, the patients will be treated with received intravenous (IV) citicoline with a dosage of 0.5 gr/ twice a day(group B) and the treatment period will be 14 days.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, the patients will be treated with received intravenous (IV) citicoline with a dosage of 1.5 gr/ twice a day(group C) and the treatment period will be 14 days.
Category
Treatment - Drugs
3
Description
Control group: the patients in this group will not receive citicoline and Only receive instilled sterile water as placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Educational Hospital
Full name of responsible person
Dr. Jalal Ahmadi
Street address
Neurosurgery Ward, Emam Reza Educational Hospital, Taleghani Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Fax
+98 56 3222 7686
Email
emamreza@bums.ac.ir
Web page address
https://emamreza.bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Asghar Zarban
Street address
Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
public_r@bums.ac.ir
Web page address
http://www.bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
1
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
Birjand University of Medical Sciences
Full name of responsible person
Soroush Hozeifi
Position
School of Medicine, Birjand University of Medical Sciences, Birjand, Iran
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Moallem Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
soroush.hozeifi@gmail.com
Web page address
http://www.bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Jalal Ahmadi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Moallem Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
jahmadi@bums.ac.ir
Web page address
http://www.bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ali Rajabpour-sanati
Position
School of Medicine, Birjand University of Medical Sciences, Birjand, Iran
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Moallem Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
ali.poursanati@gmail.com
Web page address
http://www.bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The entire statistical data from this study can be shared as needed based on the ethics committee's criteria.
When the data will become available and for how long
The results of this study, after publishing the results as a paper, will be published and shared.
To whom data/document is available
The data from this study will be available to all researchers.
Under which criteria data/document could be used
All academic researchers, in the form of research projects approved by the Ethics Committee, are allowed to access the data and perform the necessary analyzes on the documentation of this research.
From where data/document is obtainable
Applicants for obtaining documentation of this study can request information by email with the corresponding author.
What processes are involved for a request to access data/document
Applicants for obtaining documentation of this study can request information by email with the corresponding author.