Omega3 PUFA in Head Trauam (SMOFbrain)
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
omega-3 enriched SMOF lipid emusion
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- mild to moderate head trauma
Exclusion Criteria:
- sensitivity to SMOF lipid severe head trauama
Sites / Locations
- Mansoura universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
SMOF group
Arm Description
Control group in which patients will follow our local protocol for TBI management without SMOF-lipid infusion
SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days.
Outcomes
Primary Outcome Measures
Glasgow coma scale after 48 hour of infusion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02762539
Brief Title
Omega3 PUFA in Head Trauam
Acronym
SMOFbrain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Traumatic brain injury (TBI) is major health problem that stands as a significant cause of death and permanent disability. TBI is considered as global public health epidemic. On pathophysiologic basis, TBI is described as occurring in two phases, primary and secondary. Once a primary insult occurs like trauma or ischemia, the secondary injury begins though main four mechanisms; ischemia, brain edema, axonal injury and neuro-inflammation. Omega-3 PUFAs (Polyunsaturated fatty acids) are postulated to have neuroregenerative properties with the ability to impact all four main mechanisms of the secondary injury Patients will be allocated into one of two groups through a random table generation; Control group in which patients will follow our local protocol for TBI management without SMOF-lipid infusion. SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group in which patients will follow our local protocol for TBI management without SMOF-lipid infusion
Arm Title
SMOF group
Arm Type
Experimental
Arm Description
SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days.
Intervention Type
Drug
Intervention Name(s)
omega-3 enriched SMOF lipid emusion
Primary Outcome Measure Information:
Title
Glasgow coma scale after 48 hour of infusion
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild to moderate head trauma
Exclusion Criteria:
sensitivity to SMOF lipid severe head trauama
Facility Information:
Facility Name
Mansoura university
City
Al Manşūrah
State/Province
Dkahleya
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alreafey Kandeel, MD
Phone
00201008158591
Email
refa3ey2@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Omega3 PUFA in Head Trauam
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