The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT)
The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial
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.
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.
single dose administered intravenously
placebo - saline solution
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.