Omega3 PUFA in Head Trauam

Traumatic Brain Injury Clinical Trial

— SMOFbrain  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762539
• Other study ID #: Omega 3 head injury
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2016
• Last updated: November 25, 2017
• Start date: June 2016
• Est. completion date: January 2018

Study information

• Verified date: November 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• mild to moderate head trauma

Exclusion Criteria:

• sensitivity to SMOF lipid severe head trauama

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Drug:
• omega-3 enriched SMOF lipid emusion

Locations

Country	Name	City	State
Egypt	Mansoura university	Al Mansurah	Dkahleya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow coma scale after 48 hour of infusion		48 hours