Protocol summary

Study aim
The role of neuroprotic erythropoietin in overcoming severe brain trauma
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 136 patients. It is used for block randomization with sealed envelopes
Settings and conduct
In Shahid Kamyab Hospital of Mashhad, with a sample size of 136 people who were randomly divided into two groups, and in the experimental group, erythropoietin was injected in the first six hours, and then repeated on the third, sixth, ninth, and twelfth days, subcutaneously, and in the control group, We inject normal saline subcutaneously in the first six hours on the third, sixth, and twelfth days, and the consequences are checked by GCS alertness assessment weekly during hospitalization and six months after discharge with GOS
Participants/Inclusion and exclusion criteria
All patients with severe brain trauma with glasgow scale score (GCS) are less than eight, less than six hours past their trauma and have between 18 and 75 years of age And they have no history of coagulation and DVT disorders and chronic kidney disorders
Intervention groups
The sample is divided into two groups after randomization, erythropoietin is injected subcutaneously in one group and normal saline is injected subcutaneously in the other group.
Main outcome variables
Glasgow coma scale (GCS),Glasgow outcome scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230901059316N1
Registration date: 2024-01-16, 1402/10/26
Registration timing: prospective

Last update: 2024-01-16, 1402/10/26
Update count: 0
Registration date
2024-01-16, 1402/10/26
Registrant information
Name
Afshin Eslamirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3866 1788
Email address
eslamirada971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-10-10, 1403/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the neuroprotective effect of erythropoietin in patients with severe traumatic brain injury
Public title
Investigating the neuroprotective effect of erythropoietin in severe brain trauma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with brain trauma with GCS consciousness less than eight who have been treated medically Less than six hours have passed since the patient's trauma
Exclusion criteria:
Chronic coagulation disorders Chronic kidney disease History of DVT and pulmonary embolism
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
The envelope method is that the envelopes will be prepared and printed and placed inside the envelope by a member of the research team and random numbers with the help of Randomaize.com. The envelope door will be closed and the contents will not be visible from the outside.The purpose of the study is then first explained to the person who has the conditions set forth, and the person, if desired, signs the informed consent form and removes an envelope and then opens it It enters into the intervention or control group based on the contents of the individual envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and the nurse do not know about the injection drug that is erythropoietin or placebo
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Faculty of Medicine, azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.270

Health conditions studied

1

Description of health condition studied
Severe brain trauma
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effect of erythropoietin on increased alertness is measured by periodic examinations based on a score from GCS (Glasgow coma scale)
Timepoint
Six weeks and six months after the intervention
Method of measurement
Glasgow coma scale ,Glasgow outcome scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 100 mg per kilogram of erythropoietin in six hours of arrival and then repeated in the third, sixth, ninth and twelfth days
Category
Treatment - Drugs

2

Description
Control group: Injection of 10 cc normalsalin 0/9 % in six hours upon arrival and then repeated on the third, sixth, ninth and twelfth days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid kamyab hospital
Full name of responsible person
Afshin Eslamirad
Street address
Fadaeyan eslam st
City
Mashhad
Province
Razavi Khorasan
Postal code
9166637477
Phone
+98 51 3859 2121
Fax
+98 51 3854 9234
Email
eslamirada971@mums.ac.ir
Web page address
https://h-kamyab.mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafghodi
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Fax
+98 51 3882 8560
Email
MDS.Dean@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Afshin eslamirad
Position
neurosurgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Fadaeian Islam St
City
Mashhad
Province
Razavi Khorasan
Postal code
9166637474
Phone
+98 51 3859 2121
Fax
+98 51 3854 9234
Email
afshin.eslamirad19122@gmail.com
Web page address
https://h-kamyab.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afshin eslamirad
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Fadaeian Islam st
City
Mashhad
Province
Razavi Khorasan
Postal code
9166637474
Phone
+98 51 3859 2121
Fax
+98 51 3854 9234
Email
afshin.eslamirad19122@gmail.com
Web page address
https://h-kamyab.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afshin eslamirad
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Fadaeian Islam
City
Mashhad
Province
Razavi Khorasan
Postal code
9166637474
Phone
+98 51 3859 2121
Fax
+98 51 3854 9234
Email
afshin.eslamirad19122@gmail.com
Web page address
https://h-kamyab.mums.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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