Objective: according to recent studies there are some good evidences of neurprotective effect of erythropoeitin. In this study we want to investigate any neurprotective effect of erythropoeitin in traumatic brain injury.
Methods: in this double blind controlled randomized clinical trial 50 patients with traumatic brain injury admitted in less than 24 hour time and according to the inclusion/exclusion criteriawill be recruited randomly 25 patients in case group will be treated in 3 continuous days with 40000Unit EPO daily(infusion in 100CC NS in Half an Hour time) and other 25 patient in control group will be infused with NS alone.
The time of this trial will be 3 continuos days after the incident initial out come will be the neurologic status of the patient measured with MMSE and GCS and any morbidity or mortality effect.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110267917N1
Registration date:2013-01-18, 1391/10/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-18, 1391/10/29
Registrant information
Name
Hamed Aghdam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3352 3126
Email address
h-aghdam@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of neuroprotective effects of erythropoietin in human traumatic brain injuries
Public title
Neuroprotective effect of erythropoietin in human traumatic brain injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: traumatic brain injury (admit GCS: 9-13); admit less than 24 hour of the incident.
Exclusion criteria: every traumatic brain injury with arrival GCS out of range of 9-13; hypoxia(O2Sat<90%) without any response to primary airway management procedures such as oxygenation with mask ventilation; any case with operable brain trauma according to initial brain CT Scan or every stage of the hospitalizatin; any necessity to surgical treatment in any stage of the hospitalization; any past history of cardiologic, renal, pulmonary, and hepatic disorders and also Diabetes Mellitus or severe symptomatic uncontroled Hypertension(SBP>=160mmHg) or MAP < 60 mmHg.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Tehran University of Medical Sciences/medicine faculty
Street address
six florrr/central office/cross of Ghods St. and Keshavarz Blv.
City
Tehran
Postal code
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
130/304/د/91
Health conditions studied
1
Description of health condition studied
Traumatic Brain Injury
ICD-10 code
S06
ICD-10 code description
Acceleration/deceleration induced Head Trauma
Primary outcomes
1
Description
Mental state (GCS)
Timepoint
As long as patient is admitted or deceased(at most 1 month)(intervals 72 hour,1 week, and 1 month)
Method of measurement
GCS
Secondary outcomes
1
Description
Neourologic exam(Barthel Criteria)
Timepoint
Days 3, 5, 10 and until patient would be discharged or deseased
Method of measurement
Data recording by a blinded clinician
Intervention groups
1
Description
cases randomelywill be divided into 2 groups of epo group(treatment group) and control group each recruited 25 patients.
in epo group(treatment group) in 3 continuos days the cases will infused with 40000 unit of erythropoeitin in 100cc NS in 30 min. time.
Category
Treatment - Drugs
2
Description
in the control group patients witch are selected randomely according to the same inclusion/exclusion criteria , will be infused with 100 cc NS to perform blindness.