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

Hypothermia Clinical Trial

Official title:

A Multi-center, Randomized, Controlled Trial to Investigate the Efficacy and Safety of Long-term Therapeutic Hypothermia in Adult Patients With Poor-grade Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03442608
• Other study ID #: LTHSAH-1
• Status: Not yet recruiting
• Phase: N/A
• First received: January 16, 2018
• Last updated: February 23, 2018
• Start date: March 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2018
• Source: Xuanwu Hospital, Beijing
• Contact: Xin Qu, MD,PhD
• Phone: 86-10-83198633
• Email: xinqu0213[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Hypothermia
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (14)

Lead Sponsor

Collaborator

Xuanwu Hospital, Beijing

Beijing Tiantan Hospital, Central South University, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Wenzhou Medical Univeristy, First Hospital of Jilin University, Qilu Hospital of Shandong University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shandong Provincial Hospital, Shanxi Province Cardiovascular Hospital, Tang-Du Hospital, The First Affiliated Hospital of Dalian Medical University, Yantai Yuhuangding Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological function	The neurological function will be evaluated at 6 months after hemorrhage by 2 specialized investigators who are unaware of the patients' allocation according to five-category Glasgow Outcome Scale as follows: 1, death; 2, vegetative state - unable to interact with the environment; 3, severe disability - unable to live independently but able to follow commands; 4, moderate disability - capable of living independently but unable to return to work or school; and 5, good recovery - able to return to work or school.	6 months after hemorrhage
Secondary	Intracranial pressure	The effect of long-term hypothermia on ICP control will be determined.	Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, until the monitor is removed
Secondary	Length of ICU stay	The numbers of days in the ICU	6 months post hemorrhage
Secondary	Length of hospital stay	The numbers of days in the hospital.	6 months post hemorrhage
Secondary	Frequency of complications	Frequency of complications during the the study such as pneumonia, coagulation disturbance,electrolyte disturbances, liver and kidney function abnormality will be recorded and compared between groups.	6 months post hemorrhage
Secondary	Mortality rate	The proportion of death will be determined	6 months after hemorrhage