The aim of the study is to evaluate the effect of L-carnitine on NSE in patients with traumatic brain injury. Inclusion criteria are patients aging 18-75 years with traumatic brain injury in last 24 hours. Exclusion criteria are patients with diarrhea, abdominal cramps, kidney failure undergoing dialysis, history of heart disease and history of sensitivity to L-carnitine. After approval of the ethical committee of the university and taking an informed consent, 40 patients diagnosed with DAI (Diffuse axonal injury) will be admitted. All patients will receive standard treatment based on the type of trauma. They will also receive assistance therapy. They will randomly be divided into two groups. The first group will receive standard and common treatment. They will also receive enteral L-carnitine 1g/12hr. The second group will receive standard treatment plus placebo. The study will take on for a week. During this time, the vital signs and patient information will be recorded. All patients will have CTscan. Then it will be replicated based on the clinical situation during the study. Blood samples will be taken from all patients on the zero day (after trauma) and the 3rd and the 7th days, and will be evaluated by NSE kit. Cognitive and behavioral complication, findings of brain CT scan, signs of hemodynamics, length of hospital stay will be recorded at one and three month intervals after discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410312582N9
Registration date:2014-12-22, 1393/10/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-22, 1393/10/01
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-Carnitine on inflammatory biomarker level of NSE (Neurone specific Enolase) in traumatic brain injury patients
Public title
Effect of L-carnitine inpatients with traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients aging 18-75 years with traumatic brain injury in last 24 hours
Exclusion criteria:having brain trauma in more than previous 24 hours; diarrhea; abdominal cramps; patients with kidney failure undergoing dialysis; history of heart disease; history of sensitivity to L-carnitine; having other traumas such as organic trauma; hypertension; alcoholic cirrhosis
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2014-08-06, 1393/05/15
Ethics committee reference number
5/4/5598-9395
Health conditions studied
1
Description of health condition studied
Traumatic Brain Injury
ICD-10 code
G93.6
ICD-10 code description
Cerebral oedema traumatic (S06.1)
Primary outcomes
1
Description
Glascow Coma Scale(GCS)
Timepoint
1 week
Method of measurement
assay with GCS(Eye opening, limb movement, verbal)
Secondary outcomes
empty
Intervention groups
1
Description
In control group, all patients receive placebo every 12 hours as enteral feeding in addition to standard treatment for traumatic brain injury for one week.
Category
Placebo
2
Description
In intervention group, all patients receive L-carnithine 1 g/12hours as enteral feeding in addition to standard treatment for traumatic brain injury for one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital ICU
Full name of responsible person
Ata Mahmoodpoor
Street address
Shohada Hospital, El-goli street
City
Tabriz
2
Recruitment center
Name of recruitment center
General ICU of Imam Reza Hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Imam Reza Hospital, Golghasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Farhudi
Street address
Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz University of Medical Sciences
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
Anesthesiology Department, Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Director of ICU, Associate Professor
Other areas of specialty/work
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
mahmoodpoora@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Department, Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
ICU director, Associate Professor
Other areas of specialty/work
Street address
Faculty of Medicine, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
mahmoodpoora@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Department, Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Rasouli
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Anesthesiology department office, Faculty of Medicine, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
dr.f.rasouli@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)