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

This study has been completed.
Sponsor:
Collaborator:
Defence Research and Development Canada
Information provided by (Responsible Party):
Dr. Laurie Morrison, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01642524
First received: July 11, 2012
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Traumatic Brain Injury
 Biological: hypertonic saline mixed Dextran
Biological: Saline solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 30 day survival [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 48 hrs after admission ] [ Designated as safety issue: No ]
    •Survival: 48 hours after admission; Hospital discharge

  • Functional neurological outcomes at 4 months [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
  • Neuropsychological testing at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Neuropsychological testing at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Physiologic parameters indicative of organ dysfunction [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Structural parameters indicative of brain injury or dysfunction at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Serum inflammatory markers measured on arrival, 12, 24, 48 hours later [ Time Frame: 12, 24, 48 hours later ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: April 2004
Study Completion Date: July 2011
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: July 11, 2012
Last Updated: July 13, 2012
Health Authority: Canada: Canada Therapeutics Products Directorate Registration Number 092523

Keywords provided by Sunnybrook Health Sciences Centre:
resuscitation

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Dextrans
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes

ClinicalTrials.gov processed this record on May 19, 2013