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

NCT ID: NCT03442608

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-12-31

Brief 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.

Detailed Description

Aneurysmal subarachnoid hemorrhage (aSAH), especially poor-grade aSAH, is a medical emergency with very high morbidity and mortality rates. SAH constitutes a major public health concern in developed and developing countries. There were several clinical trials of hypothermia for aSAH conducted, however, with conflicting results.

Hypothermia therapy treatment is currently used in our department and other large neurosurgical centers across China to decrease the intracranial pressure (ICP), mitigate some of the destructive processes, and improve the functional outcome of patients with poor-grade aSAH. When the decision was made, the patients would be placed in wrapped cooling blankets or intravascular cooling device after they were sedated, intubated and mechanically ventilated. The patients would receive continuous infusions of some drugs using an infusion pump to prevent shivering. Once the patient's rectal, nasopharyngeal or blood temperature reached 32˚C, it was kept at approximately that temperature (32-35˚C) 3 to 7 days. Then the patients were passively rewarmed to a temperature of 36 to 37˚C at a rate no greater than 0.25˚C/hour, by gradual adjustment of the blanket thermostat.

The present multi-center, randomized controlled trials is designed to investigate the efficacy and safety of long-term (3 days) mild hypothermia versus normothermia on the outcome of patients with poor-grade aSAH. The primary outcome is the neurological function assessed at 1,3, 6 months post injury with the Glasgow Outcome Score (GOS). Additionally, the following data will also be recorded and compared: the baseline data, Glasgow Coma Score,imaging examination (e.g. CT scan), intracranial pressure, laboratory tests (e.g. blood routine test, liver and kidney function, blood gas analysis, etc), the complications (e.g. pneumonia, significant bleeding) and so on.

Conditions

Hypothermia; Aneurysmal Subarachnoid Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

mild hypothermia

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

Group Type: EXPERIMENTAL

Zoll 2000 and/or CureWrap 3500 cooling system

Intervention Type: PROCEDURE

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

northermia

normal physical cooling methods,like ice bag, conditionally required.

Group Type: PLACEBO_COMPARATOR

Zoll 2000 and/or CureWrap 3500 cooling system

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 18 - 65 years within 72 hours after subarachnoid hemorrhage;
• Neurosurgical clipping or coiling for aneurysm;
• Hunt-Hess IV-V scale;
• The intracranial pressure is more than 20 mmHg.

Exclusion Criteria

• GCS of 3 with bilateral fixed and dilated pupils;
• No spontaneous breathing or cardiac arrest at the scene of hemorrhage;
• No consent;
• Pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Central South University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Tang-Du Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Shanxi Cardiovascular Hospital

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Ning Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ning Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital,Capital Medical University, Beijing

Central Contacts

Xin Qu, MD,PhD

Role: CONTACT

xinqu0213@126.com

86-10-83198633

References

Seule MA, Muroi C, Mink S, Yonekawa Y, Keller E. Therapeutic hypothermia in patients with aneurysmal subarachnoid hemorrhage, refractory intracranial hypertension, or cerebral vasospasm. Neurosurgery. 2009 Jan;64(1):86-92; discussion 92-3. doi: 10.1227/01.NEU.0000336312.32773.A0.

Reference Type: BACKGROUND

PMID: 19050656 (View on PubMed)

Qu X, Shang F, Zhao H, Qi M, Cheng W, Xu Y, Jiang L, Chen W, Wang N, Zhang H. Targeted temperature management at 33 degrees Celsius in patients with high-grade aneurysmal subarachnoid hemorrhage: a protocol for a multicenter randomized controlled study. Ann Transl Med. 2021 Apr;9(7):581. doi: 10.21037/atm-20-4719.

Reference Type: DERIVED

PMID: 33987279 (View on PubMed)

Other Identifiers

LTHSAH-1

Identifier Type: -

Identifier Source: org_study_id