Status:
COMPLETED
Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Sunnybrook Health Sciences Center, Toronto
Defence Research and Development Canada
Conditions:
Brain Injuries
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 t...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age ≥ 16;
- Initial assessment of GCS 8 or less;
- Blunt traumatic mechanism of injury.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00878631
Start Date
September 1 2004
End Date
December 1 2008
Last Update
April 9 2009
Active Locations (2)
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1
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
2
St Michael's Hospital
Toronto, Ontario, Canada, M5V 1W8