Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE July 11, 2012
First Posted Date  ICMJE July 17, 2012
Last Update Posted Date July 17, 2012
Study Start Date  ICMJE April 2004
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
30 day survival [ Time Frame: 30 days after discharge ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT)
Official Title  ICMJE The Toronto Prehospital Hypertonic Resuscitation-Head Injury and Multi Organ Dysfunction Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Biological: hypertonic saline mixed Dextran
    single dose administered intravenously
  • Biological: Saline solution
    placebo - saline solution
Study Arms  ICMJE
  • Experimental: hypertonic saline mixed Dextran
    hypertonic saline mixed Dextran
    Intervention: Biological: hypertonic saline mixed Dextran
  • Placebo Comparator: Placebo controlled
    Saline solution
    Intervention: Biological: Saline solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2012)
114
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01642524
Other Study ID Numbers  ICMJE TOPHR HIT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Laurie Morrison, St. Michael's Hospital, Toronto
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Defence Research and Development Canada
Investigators  ICMJE Not Provided
PRS Account Sunnybrook Health Sciences Centre
Verification Date July 2012

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