The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT) (TOPHR HIT)
|Traumatic Brain Injury||Biological: hypertonic saline mixed Dextran Biological: Saline solution||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
|Official Title:||The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial|
- 30 day survival [ Time Frame: 30 days after discharge ]
- Survival [ Time Frame: 48 hrs after admission ]•Survival: 48 hours after admission; Hospital discharge
- Functional neurological outcomes at 4 months [ Time Frame: 4 Months ]
- Neuropsychological testing at 4 months [ Time Frame: 4 months ]
- Neuropsychological testing at 1 year [ Time Frame: 1 year ]
- Physiologic parameters indicative of organ dysfunction [ Time Frame: 4 months ]
- Structural parameters indicative of brain injury or dysfunction at 4 months [ Time Frame: 4 months ]
- Serum inflammatory markers measured on arrival, 12, 24, 48 hours later [ Time Frame: 12, 24, 48 hours later ]
|Study Start Date:||April 2004|
|Study Completion Date:||July 2011|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Experimental: hypertonic saline mixed Dextran
hypertonic saline mixed Dextran
Biological: hypertonic saline mixed Dextran
single dose administered intravenously
Placebo Comparator: Placebo controlled
Biological: Saline solution
placebo - saline solution
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.
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