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

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 3

Conditions: Traumatic Brain Injury

Treatments: Biological: hypertonic saline mixed Dextran; Biological: Saline solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01642524

TOPHR HIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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114 participants in 2 patient groups, including a placebo group

hypertonic saline mixed Dextran

Experimental group

Description:

hypertonic saline mixed Dextran

Treatment:

Biological: hypertonic saline mixed Dextran

Placebo controlled

Placebo Comparator group

Description:

Saline solution

Treatment:

Biological: Saline solution