drugset / Trial / NCT01333488

Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects

NCT01333488

Phase 2 Terminated 6 enrolled United States Department of Defense
RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients. This is a study to compare the outcomes of patients with severe traumatic brain injury who have been allocated to one of the following three groups: Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have their core body temperature lowered to 34C Group 3 - Subjects will have their core body temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium sulfate.

Timeline

Start
2011-12
Primary completion
2014-03
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Magnesium Sulfate Other / unclassified Intravenous