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

This study has been completed.
Sponsor:
Collaborators:
Sunnybrook Health Sciences Center, Toronto
Defence Research and Development Canada
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00878631
First received: April 8, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 8, 2009
April 8, 2009
September 2004
January 2006   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • randomization compliance rate [ Time Frame: duration of enrolment ] [ Designated as safety issue: No ]
  • ease of protocol implementation in the out-of-hospital setting [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  • adverse event rate of hypertonic saline dextran infusion [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • magnetic resonance imaging to evaluate effects of HSD on brain atrophy post-injury [ Time Frame: 4 months post incident ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline
The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial

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:

  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 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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Brain Injuries
  • 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
  • Drug: Normal Saline
    250 ccs of normal saline infused within 4 hours of the accident
  • Active Comparator: 1 Normal Saline
    infusion of 250 ccs of Normal Saline within 4 hours of the accident
    Intervention: Drug: Normal Saline
  • 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
    Intervention: Drug: hypertonic saline mixed with dextran

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
December 2008
January 2006   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00878631
TOPHR HIT, No.w7711-027801/001/TOR
No
Laurie Morrison, St Michael's Hospital
St. Michael's Hospital, Toronto
  • Sunnybrook Health Sciences Center, Toronto
  • Defence Research and Development Canada
Not Provided
St. Michael's Hospital, Toronto
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP