Protocol summary

Summary
The purpose of this study is to investigate the effect of erythropoietin on size of brain lesions and outcome in patients with severe head injury. Severe brain-injured patients (Glasgow coma scale less than or equal to 8) with a single brain lesion volume less than 30 ml or those who have diffuse axonal injury are to be included and those who need surgical operation, polycythemic cases and those may not be followed during the project will be excluded from the study. Brain-injured cases with occurrence time more than 8 hours also are not to be included. In this double-blind study 60 patients will be randomly divided into two groups of 30. Patients in intervention group will be received erythropoietin 33000 IU in 50 ml normal saline during 30 min as an infusion. Erythropoietin will be repeated in the same dose 24 and 48 hours later. In another arm of the study, normal saline will be infused instead of erythropoietin as placebo. All of the patients will be checked for CT- Scan and laboratory tests including, hematocrite, hemoglobin, complete blood count, platelet count, ferritin and iron levels, electrolytes, glucose, blood urea nitrogen and creatinine before, 15 and 30 days after intervention and results will be recorded. Patients will be called 3 and 6 months after the beginning of the study, and their Glasgow outcome score will be recorded. Finally, analysis will be performed and patients' results will be compared regarding brain lesion size and outcome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013072414138N1
Registration date: 2013-09-08, 1392/06/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-09-08, 1392/06/17
Registrant information
Name
Mehrdad Mahdian
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1562 0634
Email address
mahdian_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of erythropoietin and placebo on lesion size and outcome (Glasgow Outcome Score) in the severe brain-injured patients
Public title
Effect of erythropoietin on outcome of severe brain injured patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: severe brain injury (Glasgow coma scale less than or equal to 8) with a single brain lesion volume less than 30 ml or those who have diffuse axonal injury; age between 15-65 years; no need for surgical operation; possibility of following up during the study period; having informed consent from first-degree relatives. Exclusion criteria: mild to moderate brain injury; patients with massive brain lesions( more than 30 ml volume); age less than 15 and over 65; surgical operation; cases with neoplasia in skull; multiple trauma; myeloproliferative diseases; polycythemia; sensitivity to erythropoietin; hyperkalemia; creatinine more than 3 mg/dl; all patients that their following- up is not guaranteed during the study; participating other trials; history of deep vein thrombosis; pregnancy; clinical brain death (without brain stem reflexes).
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ghotb-e ravandi Blvd.
City
Kashan
Postal code
8719674591
Approval date
2013-05-18, 1392/02/28
Ethics committee reference number
29/5/1/625/پ

Health conditions studied

1

Description of health condition studied
Traumatic brain injury
ICD-10 code
S06.2 , S0
ICD-10 code description
Diffuse brain injury , Focal brain injury

Primary outcomes

1

Description
Patient's outcome
Timepoint
3 and 6 month after intervention
Method of measurement
Based on Glasgow coma scale

2

Description
Lesion size
Timepoint
Before, 15 and 30 days after intervention
Method of measurement
Based on CT-Scan and radiologist's report

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group: After the arrival of the patient into the study and within 8 hours after the occurrence of the brain Injury, erythropoietin will be infused at the rate of 33000 IU/50 ml normal saline /30 min intravenously. This dosage will be repeated in next 24 and 48 hours.
Category
Treatment - Drugs

2

Description
In the control group: After the arrival of the patient into the study and within 8 hours after the occurrence of the brain Injury, normal saline will be infused at the rate 50 ml in 30 minutes intravenously. This dosage will be repeated in next 24 and 48 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan University of Medical Sciences, Shahid Beheshti hospital
Full name of responsible person
Mehrdad Mhdian
Street address
Qutb-e Ravandi Blvd.
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences, Deputy of Research
Full name of responsible person
Gholam Ali Hamidi
Street address
Qutb-e ravandi Blvd.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences, Deputy of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Mahdian
Position
Faculty member/ MSc (Anesthesia)
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
8719674591
Phone
+98 36 1562 0634
Fax
+98 36 1562 0634
Email
mahdian_m@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammd Reza Fazel
Position
Faculty member/ Anesthesiologist
Other areas of specialty/work
Street address
Qutb-e ravandi Blvd
City
Kashan
Postal code
8719674591
Phone
+98 36 1562 0634
Fax
+98 36 1562 0634
Email
Drfazel@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehrdad Mahdian
Position
Faculty member/ MSc (Anesthesia)
Other areas of specialty/work
Street address
Qutb-e ravandi Blvd.
City
Kashan
Postal code
8719674591
Phone
+98 36 1562 0634
Fax
+98 36 1562 0634
Email
mahdian_m@kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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