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Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury
Sponsor: RenJi Hospital
Summary
This study is a prospective multi-centre randomized trial to compare the effect of long-term mild hypothermia versus routine normothermic intensive management in patients with severe traumatic brain injury. The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35℃) for 5 days will improve the outcome of patients at six months post injury compared with normothermia.
Official title: A Multi-center, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Long-term Mild Hypothermia in Adult Patients With Severe Traumatic Brain Injury
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2013-11-12
Completion Date
2019-06-30
Last Updated
2026-08-13
Healthy Volunteers
No
Conditions
Interventions
Long-term mild hypothermia
Hypothermia will be induced within 6 hours of injury and maintained at 34-35℃ for 5 days.Then the patients will be passively rewarmed to a temperature of 36 to 37˚C at a rate no greater than 0.5˚C/4 hours.
Normothermia
Patients assigned to the normothermia group will be kept at 36-37℃.
Locations (1)
Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China