Traumatic Brain Injury
Conditions
Keywords
resuscitation
Brief summary
The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present with an injury to their head which makes them unconscios. The study compares two different fluids given to the patient in the out of hospital setting by a paramedic. The two fluids are salt water (standard treatment) versus a higher concentration of salt water mixed with a sugar (study fluid). The patients have an equal chance of receiving either fluid and the paramedic and the patient and the treating trauma surgeon do not know which fluid was provided in the out of hospital setting.
Detailed description
Study Objective The primary objective of this study is to report feasibility in accordance with the methodology described by Lancaster and Dodds, specifically addressing: 1. baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial. 2. randomization compliance rate. 3. ease of protocol implementation in the out-of-hospital setting. 4. adverse rate of Hypertonic Saline Dextran (HSD) infusion. The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.
Interventions
BIOLOGICALhypertonic saline mixed Dextran
single dose administered intravenously
BIOLOGICALSaline solution
placebo - saline solution
Sponsors
Defence Research and Development Canada
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥16 * Initial assessment of Glasgow Coma Score (GCS) 8 or less * Blunt traumatic mechanism of injury
Exclusion criteria
* Known pregnancy * Penetrating primary injury * VSA prior to randomization; previous intravenous therapy ≥ 50 ml * Time interval between arrival at scene and intravenous access exceeds four hours * Amputation of above wrist or ankle * Any burn (thermal, chemical, electrical, radiation) * Suspected hypothermia * Asphyxia (strangulation, hanging, choking, suffocation, drowning) and fall from height ≤ 1m or ≤ 5 stairs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 day survival | 30 days after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional neurological outcomes at 4 months | 4 Months | — |
| Survival | 48 hrs after admission | •Survival: 48 hours after admission; Hospital discharge |
| Neuropsychological testing at 4 months | 4 months | — |
| Neuropsychological testing at 1 year | 1 year | — |
| Physiologic parameters indicative of organ dysfunction | 4 months | — |
| Structural parameters indicative of brain injury or dysfunction at 4 months | 4 months | — |
| Serum inflammatory markers measured on arrival, 12, 24, 48 hours later | 12, 24, 48 hours later | — |
Outcome results
None listed