Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)

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.

Conditions

• Brain Injuries, Traumatic

Interventions

DRUG

7.5% Hypertonic Saline in 6% Dextran-70 (HSD)

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.

DRUG

7.5% Hypertonic Saline (HS)

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.

DRUG

0.9% Normal Saline (NS)

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• U.S. Army Medical Research and Development Command

  collaborator FED

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Canadian Department of National Defense

  collaborator OTHER_GOV

• Heart and Stroke Foundation of Canada

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Myron L Weisfeldt, MD · Resuscitation Outcomes Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2009-05-31

Completion

2010-01-31

Countries

• United States
• Canada

Study Locations