Traumatic Brain Injury
Conditions
Brief summary
To test the feasibility of administering a commercially available neurotrophic oral nutritional supplement (ONS) for adult patients with acute traumatic brain injury at the Royal London Hospital.
Detailed description
The study will be a randomised controlled non-blinded trial of adult patients with acute traumatic brain injury at the Royal London Hospital. There will be randomisation to one of two non-blinded trial groups: 1. Usual standard NHS care (control group) 2. Usual standard NHS care plus daily oral dose of Souvenaid® ONS The trial protocol will commence between 3-7 days after admission. The trial timeline provides a summary of intervention and assessments. The trial will last 12 months. The first 6 months will be the formal trial with two groups and follow up assessments. This will be performed on intention to treat basis. After this initial phase the investigators will provide an opportunity for all participants from either group (control or treatment) to take Souvenaid® ONS for a further 6 months with a clinical follow up appointment.
Interventions
DIETARY_SUPPLEMENTSouvenaid oral nutritional supplement (Nutricia)
Daily dose of a commercially available oral nutritional supplement based around the active compound recipe Fortasyn Connect, produced by Nutricia, Danone.
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult between 18 yrs and 80 yrs of age * Acute traumatic brain injury with confirmed radiological features
Exclusion criteria
* Allergies to fish oil/milk/soya * Medical history of galactosaemia * Non-traumatic aetiology to head injury * Unable to receive enteral nutrition * Craniectomy during admission (loss of integrity of skull convexity) * Concurrent active neurological disease * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility to conduct the protocol as stated | 10 months | To assess logistical issues which might prevent a fully powered study being carried out using this protocol. The investigators will primarily be looking at retention rate. If there is an attrition rate of over 80% then this protocol will be deemed not feasible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | 10 months | Changes to cognitive function as measure by CANTAB-TBI cognitive test. This is a validated and widely used clinical tool for cognitive assessment in TBI and assesses cognition using the following battery of tests (range of scores in brackets with lower score being worse performance and higher being better performance): paired associates learning (0-70); reaction time (100-5100); spatial working memory (0-153); multitasking test (0-160); one touch stockings of Cambridge (0-15). |
| Plasma phospholipid levels | 10 months | Plasma phospholipid levels will be measured using thin layer chromatography and/or LC-MS. Batch analysis |
| Omega-3 index | 10 months | The omega-3 index will be analysed in red blood cells. Therefore, lipids will be extracted from red blood cells, followed by transesterification and quantification using gas chromatography coupled to a flame ionisation detector. |
| Brain network connectivity | 10 months | As measured by resting state EEG |
| Inflammatory markers | 10 months | Inflammatory markers such as cytokines will be analysed using either enzyme-linked immunosorbent assays or a multiplex system. Combined samples will be run on each plate to account for inter plate variability. |
| C-reactive protein | 10 months | CRP will be measured independently using an enzyme-linked immunosorbent assay. Combined samples will be run on each plate to account for inter plate variability |
| Neurofilament light levels | 10 months | Plasma or serum neurofilament light levels will be measured using either a commercially available enzyme-linked immunosorbent assay, a commercially available chemi-luminescent assay, or the commercially available SIMOA assay. Combined samples will be run on each plate to account for inter plate variability. |
Countries
United Kingdom
Outcome results
None listed