Clinical trial to compare the effect of erythropoietin and normal saline on level of consciousness of brain trauma patients admitted to intensive care unit
The aim of this study is to increase the level of Glasgow coma scale, determining mortality and comparing days needing verntilator, comparing admission duration and comparing Sequential Organ Failure Assessment (SOFA) in trauma patients admitted to the intensive care unit of Imam Hospital of Sari.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 68 patients. Study patients are divided into two groups by simple randomization method using random numbers table.
Settings and conduct
The present study will be performed in the intensive care unit of Imam Khomeini Hospital in Sari and 68 patients will be randomly divided into two groups: intervention (receiving erythropoietin) and control (receiving normal saline).
This study is double-blind so that patients and the final evaluator will be unaware of how the intervention and control group is allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes brain trauma with moderate GCS (7-12) during the first 24 hours after trauma with an expected time of at least 48 hours for the duration of hospitalization. Exclusion criteria is history of deep vein thrombosis pulmonary embolism, or any thromboembolic event; treatment with erythropoietin in the past 30 days; systolic blood pressure ≥160; history of heart failure and cancer; elective neurosurgery.
Intervention groups
The intervention group will receive 4000 units of subcutaneous erythropoietin made by Pooyesh Daroo Company with a volume of half a cc on days 1, 3 and 5 and the control group will receive half a cc of subcutaneous normal saline 0.9% on days 1, 3 and 5 . In both groups, patients are monitored for 14 days.
Main outcome variables
Level of consciousness; Deep vein thrombosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181104041551N3
Registration date:2020-09-16, 1399/06/26
Registration timing:registered_while_recruiting
Last update:2020-09-16, 1399/06/26
Update count:0
Registration date
2020-09-16, 1399/06/26
Registrant information
Name
Fateme Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
f.heydari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to compare the effect of erythropoietin and normal saline on level of consciousness of brain trauma patients admitted to intensive care unit
Public title
Effect of erythropoietin on level of consciousness of brain trauma patients admitted to intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with brain trauma with moderate GCS (7-12)
The first 24 hours after trauma
Expected time for the duration of hospitalization, at least 48 hours
Exclusion criteria:
History of deep vein thrombosis, pulmonary embolism or any thromboembolic event
Erythropoietin treatment in the last 30 days
Systolic blood pressure ≥160
History of heart failure
History of cancer
Neurosurgery elective surgery
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control with 34 members using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the final evaluator (intensive care subspecialist) will be unaware of the allocation in the study groups. Because the drug and placebo are colorless and there is no difference in subcutaneous injection. Because the project assistant is in the process of assigning groups, the intensive care unit sub-specialist is unaware of patients assignment to each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee, Imam Hospital of Sari, Mazandaran University of Medical Sciences
Street address
Imam Hospital, Amir Mzandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
5714854367
Approval date
2020-06-16, 1399/03/27
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1399.033
Health conditions studied
1
Description of health condition studied
Brain trauma patients admitted to the ICU
ICD-10 code
S06.3
ICD-10 code description
Focal traumatic brain injury
Primary outcomes
1
Description
Level of conciousness
Timepoint
Daily until 14 days
Method of measurement
Glasgow Coma Scale and SOFA four-point scale
2
Description
Deep vein thrombosis
Timepoint
Daily
Method of measurement
Daily visit of the limbs
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive 4000 units of subcutaneous erythropoietin made by Pooyesh Daroo Company with a volume of half a cc on days 1, 3 and 5
Category
Treatment - Drugs
2
Description
Control group: The control group will receive half a cc of subcutaneous normal saline 0.9% on days 1, 3 and 5 .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hospital of Sari
Full name of responsible person
Dr. Fatemeh Heydari
Street address
Imam Hospital, Amir Mzandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
5714854367
Phone
+98 11 3334 2334
Email
f.heydari@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeidi, Vice chancellor for research, Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3336 1701
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Heydari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hospital, Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
5714854367
Phone
+98 11 3336 1701
Email
f.heydari@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Heydari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hospital, Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
5714854367
Phone
+98 11 3336 1701
Email
f.heydari@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Farhad Mohammadnezhad
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Hospital, Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
5714854367
Phone
+98 11 3334 2334
Email
f.heydari@mazums.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
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
Starting from April 2021
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Everyone
From where data/document is obtainable
Email to f.heydari@mazums.ac.ir
What processes are involved for a request to access data/document