A Phase 2/3 interventional study of hypertonic saline mixed with dextran and Normal Saline in Brain Injuries, sponsored by Unity Health Toronto. Completed at 2 sites in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-04-09.
Sponsored by Unity Health Toronto · Phase 2/3, Interventional, and Treatment
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.
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:
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.
2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's enrollment of 113 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
infusion of 250 ccs of Normal Saline within 4 hours of the accident
Drug: Normal Saline
a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 infused within 4 hours of the accident
Drug: hypertonic saline mixed with dextran
a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 is given within 4 hours from the time of the accident
Also known as: RescueFlow BioPhausia AB, Stockholm Sweden
250 ccs of normal saline infused within 4 hours of the accident
baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial
Time frame: survival at 48 hours, hospital discharge, 30 days and 4 months
randomization compliance rate
Time frame: duration of enrolment
ease of protocol implementation in the out-of-hospital setting
Time frame: duration of study
adverse event rate of hypertonic saline dextran infusion
Time frame: duration of study
neurocognitive outcomes at discharge (cerebral performance category) and at 4 months (functional independence measure, disability rating scale, Glasgow Outcome Scale and Glasgow outcome Scale Extended
Time frame: discharge and at 4 months post incident
neuropsychological outcomes including learning and memory, working memory, executive function, language function, visuospatial function, speed of processing and Beck Depression Scale. A focused attention reaction time test was added to 12 month testing.
Time frame: at 4 and 12 months post incident
magnetic resonance imaging to evaluate effects of HSD on brain atrophy post-injury
Time frame: 4 months post incident
the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulation the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome
Time frame: samples taken within 48 hours of incident
This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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