Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial will evaluate the ease of conducting a randomized trial on patients with severe head injury who are cared for by paramedics in the out of hospital setting. The trial will compare two different kinds of fluids that are commonly used to elevate blood pressure and minimize the impact of the brain injury. The two solutions are a salt solution of different concentrations. One is a normal saline solution similar to the consistency of human blood and the other is a higher concentration mixed with a sugar that helps to keep the solution in the blood stream longer. This study is conducted without patient consent at the time of the study enrolment. The study will report on whether this trial is feasible in the out of hospital setting before launching into a larger definitive trial.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Collaborators: Defence Research and Development Canada; Sunnybrook Health Sciences Center, Toronto
• Treatments: Dextrans

Criteria

Inclusion Criteria:

• Age ≥ 16;

• Initial assessment of GCS 8 or less;

• Blunt traumatic mechanism of injury.

Exclusion Criteria:

• Known pregnancy;

• Primary injury penetrating;

• VSA prior to randomization;

• Previous Intravenous therapy ≥ 50 ml;

• Time interval between arrival at scene and intravenous access exceeds four hours;

• Amputation above wrist or ankle;

• Any burn (thermal, chemical, electrical, radiation)

• Suspected hypothermia;

• Asphyxia (strangulation, hanging, choking, suffocation, drowning)

• Fall from height ≤ 1m or ≤ 5 Stairs