Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline (TOPHR HIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00878631|
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : April 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries||Drug: hypertonic saline mixed with dextran Drug: Normal Saline||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||December 2008|
Active Comparator: 1 Normal Saline
infusion of 250 ccs of Normal Saline within 4 hours of the accident
Drug: Normal Saline
250 ccs of normal saline infused within 4 hours of the accident
Experimental: 2 - hypertonic saline mixed with dextran
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
Other Name: RescueFlow BioPhausia AB, Stockholm Sweden
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878631
|Sunnybrook Health Sciences Center|
|Toronto, Ontario, Canada, M4N 3M5|
|St Michael's Hospital|
|Toronto, Ontario, Canada, M5V 1W8|