Status:
COMPLETED
Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
First Affiliated Hospital of Zhejiang University
West China Hospital
Conditions:
Brain Injuries
Craniocerebral Trauma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 i...
Detailed Description
Traumatic brain injury (TBI) remains a leading cause of death and disability in people with injuries and constitutes a major public health concern both in developed and developing countries. There are...
Eligibility Criteria
Inclusion
- Age 18 - 65 years within 6 hours post injury;
- Closed head injury;
- Glasgow Coma Scale(GCS) score 4 to 8 after resuscitation;
- The intracranial pressure is more than 25 mmHg;
- Cerebral contusion on computed tomographic scan.
Exclusion
- GCS of 3 with bilateral fixed and dilated pupils;
- A life-threatening injury to an organ other than the brain;
- No spontaneous breathing or cardiac arrest at the scene of the injury;
- No consent;
- Pregnancy.
Key Trial Info
Start Date :
November 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT01886222
Start Date
November 12 2013
End Date
June 30 2019
Last Update
March 12 2020
Active Locations (1)
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1
Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127