Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)

Stopped early · Phase 3

Conditions studied: Brain Injuries, Traumatic

In brief

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 trauma can cause your body to go into shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called "resuscitation". The fluid most commonly used is "isotonic" or one that is the same salt concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid or one more concentrated than the blood can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids they are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than blood. Dextran is a sugar solution.

Key facts

Study ID

NCT00316004

Run by

University of Washington

People needed

1331

Starts

2006-05-01

Expected to finish

2010-01-01

Last updated by the study team

2011-05-19

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Alabama Resuscitation Center, University of Alabama — Birmingham, Alabama, United States
• Orange County/UC Irvine — Orange, California, United States
• UCSD-San Diego Resuscitation Research Center — San Diego, California, United States
• Iowa Resuscitation Network, University of Iowa Carver College of Medicine — Iowa City, Iowa, United States
• Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University — Portland, Oregon, United States
• The Pittsburgh Resuscitation Network, University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• The Regional Medical Center at Memphis — Memphis, Tennessee, United States
• Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Seattle-King County Center for Resuscitation Research, University of Washington — Seattle, Washington, United States
• Milwaukee Resuscitation Network, Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research Institute — Ottawa, Ontario, Canada
• Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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