Status:
TERMINATED
Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if hypertonic saline with and without dextran can improve neurologic outcomes in victims of severe traumatic brain injury (TBI). Injury and lost blood from t...
Detailed Description
To determine if prehospital administration of 7.5% Hypertonic Saline in 6% Dextran-70 (HSD) OR 7.5% Hypertonic Saline (HS) compared to current standard therapy with NS as an initial resuscitation flui...
Eligibility Criteria
Inclusion
- Blunt trauma
- Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)\*
- Age 15 years or older or 50 kg or more
- Patients who met the inclusion criteria above and did not meet the exclusion criteria below but who had systolic blood pressure (SBP) ≤70 or SBP\>70 and SBP≤90 and heart rate (HR)≥108 were included in the Hypertonic Resuscitation following Traumatic Injury study that focused on shock patients who may or may not have a traumatic brain injury (TBI). In other words, patients with both TBI and shock would not be included in this study of TBI patients without shock at the time of enrollment.
Exclusion
- Known or suspected pregnancy
- Age younger than 15 years or less than 50 kg if age unknown
- Ongoing pre-hospital cardiopulmonary resuscitation (CPR)
- Administration of more than 2L crystalloid or any colloid or blood products
- Severe hypothermia (T less than 28C)
- Drowning or asphyxia due to hanging
- Burns TBSA more than 20%
- Isolated penetrating injury to the head
- Inability to obtain pre-hospital intravenous access
- Time of call received at dispatch to study intervention more than four hours
- Known prisoners
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
1331 Patients enrolled
Trial Details
Trial ID
NCT00316004
Start Date
May 1 2006
End Date
January 1 2010
Last Update
May 19 2011
Active Locations (12)
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1
Alabama Resuscitation Center, University of Alabama
Birmingham, Alabama, United States, 35249
2
Orange County/UC Irvine
Orange, California, United States, 92868
3
UCSD-San Diego Resuscitation Research Center
San Diego, California, United States, 92103
4
Iowa Resuscitation Network, University of Iowa Carver College of Medicine
Iowa City, Iowa, United States, 52242