Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline (TOPHR HIT)

U

Unity Health Toronto

Status and phase

Completed
Phase 3
Phase 2

Conditions

Brain Injuries

Treatments

Drug: Normal Saline
Drug: hypertonic saline mixed with dextran

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00878631
No.w7711-027801/001/TOR
TOPHR HIT

Details and patient eligibility

About

This clinical trial will evaluate the ease of conducting a randomized trial on patients with severe head injury who are cared for by paramedics in the out of hospital setting. The trial will compare two different kinds of fluids that are commonly used to elevate blood pressure and minimize the impact of the brain injury. The two solutions are a salt solution of different concentrations. One is a normal saline solution similar to the consistency of human blood and the other is a higher concentration mixed with a sugar that helps to keep the solution in the blood stream longer. This study is conducted without patient consent at the time of the study enrolment. The study will report on whether this trial is feasible in the out of hospital setting before launching into a larger definitive trial.

Full description

The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT) is a randomized, placebo-controlled out of hospital trial of blunt trauma patients with head injuries. The study compares a group receiving normal saline according to a paramedic's protocol, with a treatment group receiving a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 (RescueFlow BioPhausia AB, Stockholm Sweden). 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 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. *Lancaster, G.A., S. Dodd, and P.R. Williamson, Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract, 2004. 10(2): p. 307-12.

Enrollment

113 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 16;
  • Initial assessment of GCS 8 or less;
  • Blunt traumatic mechanism of injury.

Exclusion criteria

  • Known pregnancy;
  • Primary injury penetrating;
  • VSA prior to randomization;
  • Previous Intravenous therapy ≥ 50 ml;
  • Time interval between arrival at scene and intravenous access exceeds four hours;
  • Amputation above wrist or ankle;
  • Any burn (thermal, chemical, electrical, radiation)
  • Suspected hypothermia;
  • Asphyxia (strangulation, hanging, choking, suffocation, drowning)
  • Fall from height ≤ 1m or ≤ 5 Stairs

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

113 participants in 2 patient groups

1 Normal Saline
Active Comparator group
Description:
infusion of 250 ccs of Normal Saline within 4 hours of the accident
Treatment:
Drug: Normal Saline
2 - hypertonic saline mixed with dextran
Experimental group
Description:
a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 infused within 4 hours of the accident
Treatment:
Drug: hypertonic saline mixed with dextran

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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