Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline

The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT) is a randomized, placebo-controlled out of hospital trial of blunt trauma patients with head injuries. The study compares a group receiving normal saline according to a paramedic's protocol, with a treatment group receiving a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 (RescueFlow BioPhausia AB, Stockholm Sweden).

The primary objective of this study is to report feasibility in accordance with the methodology described by Lancaster and Dodds*, specifically addressing:

• baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial.
• randomization compliance rate.
• ease of protocol implementation in the out-of-hospital setting.
• adverse rate of 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.

*Lancaster, G.A., S. Dodd, and P.R. Williamson, Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract, 2004. 10(2): p. 307-12.

Inclusion criteria

• Age ≥ 16;
• Initial assessment of GCS 8 or less;
• Blunt traumatic mechanism of injury.

Exclusion criteria

• Known pregnancy;
• Primary injury penetrating;
• VSA prior to randomization;
• Previous Intravenous therapy ≥ 50 ml;
• Time interval between arrival at scene and intravenous access exceeds four hours;
• Amputation above wrist or ankle;
• Any burn (thermal, chemical, electrical, radiation)
• Suspected hypothermia;
• Asphyxia (strangulation, hanging, choking, suffocation, drowning)
• Fall from height ≤ 1m or ≤ 5 Stairs