Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Intervention: 7.5% Hypertonic Saline in 6% Dextran-70 (HSD); 7.5% Hypertonic Saline (HS); 0.9% Normal Saline (NS)
Intervention description: 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.; 250 ml intravenous bolus administration of 7.5% hypertonic saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.; 250 ml intravenous bolus administration of 0.9% saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
Intervention MeSH terms: Dextrans
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1331.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Traumatic; Brain injury

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.
    

Eligibility 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