Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury

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.

Conditions

• Brain Injuries
• Craniocerebral Trauma

Interventions

OTHER

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.

OTHER

Normothermia

Patients assigned to the normothermia group will be kept at 36-37℃.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The 101st Hospital of Chinese People's Liberation Army

  collaborator OTHER

• The 98 Hospital of People's Liberation Army

  collaborator UNKNOWN

• Shenzhen Second People's Hospital

  collaborator OTHER

• The 94 Hospital of People's Liberation Army

  collaborator UNKNOWN

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• The Affiliated Hospital of Medical College of Chinese People's Armed Police Forces

  collaborator UNKNOWN

• Xiangya Hospital of Central South University

  collaborator OTHER

• Taizhou First People's Hospital

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Chongqing Emergency Medical Center

  collaborator OTHER

• Xuzhou Central Hospital

  collaborator OTHER

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• RenJi Hospital

  lead OTHER

Principal Investigators

• Jiyao Jiang, MD, PhD · Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-12

Primary Completion

2019-06-30

Completion

2019-06-30

Countries

• China

Study Locations