Trial | NCT01642524  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    114
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.
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.
Study Started
Apr 30
2004
Primary Completion
Jan 31
2006
Study Completion
Jul 31
2011
Last Update
Jul 17
2012
Estimate

Biological hypertonic saline mixed Dextran

single dose administered intravenously

Biological Saline solution

placebo - saline solution

hypertonic saline mixed Dextran Experimental

hypertonic saline mixed Dextran

Placebo controlled Placebo Comparator

Saline solution

Criteria 

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.
No Results Posted