Clinical trial NCT01642524: The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT)
Official title: The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Traumatic Brain Injury
Keywords: resuscitation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Defence Research and Development Canada
First posted: 2012-07-17
Enrollment: 114
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 30 day survival
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Survival
timeFrame: 48 hrs after admission
measure: Functional neurological outcomes at 4 months
timeFrame: 4 Months
measure: Neuropsychological testing at 4 months
timeFrame: 4 months
measure: Neuropsychological testing at 1 year
timeFrame: 1 year
measure: Physiologic parameters indicative of organ dysfunction
timeFrame: 4 months
measure: Structural parameters indicative of brain injury or dysfunction at 4 months
timeFrame: 4 months
measure: Serum inflammatory markers measured on arrival, 12, 24, 48 hours later
timeFrame: 12, 24, 48 hours later
Other outcomes:
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