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Omega3 PUFA in Head Trauam

NCT02762539 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-11-28

No results posted yet for this study

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

Conditions

Interventions

DRUG

omega-3 enriched SMOF lipid emusion

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762539 on ClinicalTrials.gov