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The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT) (TOPHR HIT)

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ClinicalTrials.gov Identifier: NCT01642524
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : July 17, 2012
Sponsor:
Collaborator:
Defence Research and Development Canada
Information provided by (Responsible Party):
Dr. Laurie Morrison, St. Michael's Hospital, Toronto

Brief Summary:
The TOPHR HIT trial is a clinical trial of patients experiencing blunt trauma who present with an injury to their head which makes them unconscios. The study compares two different fluids given to the patient in the out of hospital setting by a paramedic. The two fluids are salt water (standard treatment) versus a higher concentration of salt water mixed with a sugar (study fluid). The patients have an equal chance of receiving either fluid and the paramedic and the patient and the treating trauma surgeon do not know which fluid was provided in the out of hospital setting.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Biological: hypertonic saline mixed Dextran Biological: Saline solution Phase 3

Detailed Description:

Study Objective

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 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial
Study Start Date : April 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries
Drug Information available for: Dextran 70
U.S. FDA Resources

Arm Intervention/treatment
Experimental: hypertonic saline mixed Dextran
hypertonic saline mixed Dextran
Biological: hypertonic saline mixed Dextran
single dose administered intravenously
Placebo Comparator: Placebo controlled
Saline solution
Biological: Saline solution
placebo - saline solution



Primary Outcome Measures :
  1. 30 day survival [ Time Frame: 30 days after discharge ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: 48 hrs after admission ]
    •Survival: 48 hours after admission; Hospital discharge

  2. Functional neurological outcomes at 4 months [ Time Frame: 4 Months ]
  3. Neuropsychological testing at 4 months [ Time Frame: 4 months ]
  4. Neuropsychological testing at 1 year [ Time Frame: 1 year ]
  5. Physiologic parameters indicative of organ dysfunction [ Time Frame: 4 months ]
  6. Structural parameters indicative of brain injury or dysfunction at 4 months [ Time Frame: 4 months ]
  7. Serum inflammatory markers measured on arrival, 12, 24, 48 hours later [ Time Frame: 12, 24, 48 hours later ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥16
  • Initial assessment of Glasgow Coma Score (GCS) 8 or less
  • Blunt traumatic mechanism of injury

Exclusion Criteria:

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

Responsible Party: Dr. Laurie Morrison, Clinician Scientist, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01642524     History of Changes
Other Study ID Numbers: TOPHR HIT
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by Dr. Laurie Morrison, St. Michael's Hospital, Toronto:
resuscitation

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Pharmaceutical Solutions
Dextrans
Anticoagulants
Plasma Substitutes
Blood Substitutes