Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Canadian Department of National Defense; Canadian Institutes of Health Research (CIHR); Heart and Stroke Foundation of Canada; National Heart, Lung, and Blood Institute (NHLBI); National Institute of Neurological Disorders and Stroke (NINDS); U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Dextrans

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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