Trial of Long-term Therapeutic Hypothermia for Poor-grade Aneurysmal Subarachnoid Hemorrhage

Summary

This study is a prospective, multi-centre, randomized,controlled trial to compare the efficacy of long-term mild hypothermia with normothermic intensive management in patients with poor-grade aneurysmal subarachnoid hemorrhage.

The primary hypothesis is that the induction of mild hypothermia (maintained at 32-35℃) for at least 5 days would improve the outcome of patients at six months post hemorrhage compared with normothermia.

Conditions

• Hypothermia
• Aneurysmal Subarachnoid Hemorrhage

Interventions

PROCEDURE

Zoll 2000 and/or CureWrap 3500 cooling system

Device(Zoll 2000 and/or CureWrap 3500 cooling system),lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Central South University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Shanxi Cardiovascular Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  lead OTHER

Principal Investigators

• Ning Wang, MD,PhD · Xuanwu Hospital,Capital Medical University, Beijing

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

2018-03-01

Primary Completion

2020-12-31

Completion

2020-12-31