Effect of citicoline on barthel index in patients with moderate and severe brain traumatic injury
Design
This study is a randomized clinical trial of double blind in which patients (80 patient) were Random Allocation software to use control groups in two groups.
Settings and conduct
This study will be performed in Kashani Medical Center. Patients and researchers will not be aware of the patient group and clinical care giver will only recognize the patients in the control and case group and will perform the intervention.
Participants/Inclusion and exclusion criteria
Patients with severe and moderate traumatic brain injury based on GCS less than 12
Patients should be without traumatic major lesions in the thorax, abdomen, and limbs
Patients without heart problems
Have the satisfaction to enter the study
Previous history of brain Injury, stroke, or neurological disease
Contraindications or sensitivity to Citicoline
The presence of comorbidities such as cardiovascular, renal, hepatic, and malignant history
Traumatic brain injury, major trauma to the thorax, abdomen and organs
Unstable hemodynamics
Surgical interventions were performed within the first 24 hours after trauma
cardiopulmonary resuscitation was performed within the first 24 hours after trauma
Dissatisfaction of the patient to enter the study and her/his death during the study
Intervention groups
The case group will be treated with citicoline with a dose of 2000 mg and twice daily as an injection for 1 week and 2000 mg oral twice daily. Patients in the control group were treated with placebo twice daily for 2 weeks.
Main outcome variables
Index Bartel (quality of life in patients with brain trauma)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200609047706N1
Registration date:2020-06-16, 1399/03/27
Registration timing:prospective
Last update:2020-06-16, 1399/03/27
Update count:0
Registration date
2020-06-16, 1399/03/27
Registrant information
Name
MohammadReza Hasas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3434 7398
Email address
mrh13691990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Citicoline on Barthel Index in Patients with Moderate and Severe Traumatic Brain Injury
Public title
Citicoline on Barthel Index in Patients with Moderate and Severe Traumatic Brain Injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe and moderate traumatic brain injury based on GCS less than 12
Patients should be without traumatic major lesions in the thorax, abdomen, and limbs
Patients without heart problems
Have the satisfaction to enter the study
Exclusion criteria:
Previous history of brain Injury, stroke, or neurological disease
Contraindications or sensitivity to Citicoline
The presence of comorbidities such as cardiovascular, renal, hepatic, and malignant history
Traumatic brain injury, major trauma to the thorax, abdomen and other organs
Unstable hemodynamics
Pregnancy
Surgical interventions were performed within the first 24 hours after trauma
cardiopulmonary resuscitation was performed within the first 24 hours after trauma
Dissatisfaction of the patient to enter the study and her/his death during the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient do not know he/ she is in which group (case or control) and the researcher do not know case qroup in research time and the clinical care giver has a list about case group and do the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciense, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.MUI.MED.REC.1399.108
Health conditions studied
1
Description of health condition studied
Patients with severe and moderate brain injury
ICD-10 code
S06.2X
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Improving the patient's barthel index
Timepoint
Upon arrival, one month, three months and six months
Method of measurement
Barthel Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Case group: citicoline drug at a dose of 2000 mg oral twice daily by injection for 1 week and 2000 mg twice daily orally
Category
Treatment - Drugs
2
Description
Control group: Taking placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mehdi Mahmoodkhani
Street address
Kashani Hospital. Kashani Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3233 0091
Email
kashani@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjouy Javanmardi
Street address
Isfahan University of Medical Science, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Isfahanuni@mui.ca.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan
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
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Mahmoodkhani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Kashani Hospital, Kashani Ave
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
mahmoodkhani@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Mahmoodkhani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Kashani Hospital, Kashani Ave
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
kashani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Hassas
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Alzahra Hospital, Sofeh Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3434 7398
Email
alzahra@mui.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