The Toronto Prehospital Hypertonic Resuscitation Head Injury and Multi Organ Dysfunction Trial (TOPHR HIT)
TOPHR HIT
1 other identifier
interventional
114
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2004
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedJuly 17, 2012
July 1, 2012
1.8 years
July 11, 2012
July 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
30 day survival
30 days after discharge
Secondary Outcomes (7)
Survival
48 hrs after admission
Functional neurological outcomes at 4 months
4 Months
Neuropsychological testing at 4 months
4 months
Neuropsychological testing at 1 year
1 year
Physiologic parameters indicative of organ dysfunction
4 months
- +2 more secondary outcomes
Study Arms (2)
hypertonic saline mixed Dextran
EXPERIMENTALhypertonic saline mixed Dextran
Placebo controlled
PLACEBO COMPARATORSaline solution
Interventions
single dose administered intravenously
Eligibility Criteria
You may qualify if:
- Age ≥16
- Initial assessment of Glasgow Coma Score (GCS) 8 or less
- Blunt traumatic mechanism of injury
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinician Scientist
Study Record Dates
First Submitted
July 11, 2012
First Posted
July 17, 2012
Study Start
April 1, 2004
Primary Completion
January 1, 2006
Study Completion
July 1, 2011
Last Updated
July 17, 2012
Record last verified: 2012-07