The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT)

Study Objective

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 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.

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.