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

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ClinicalTrials.gov Identifier: NCT03442608
Recruitment Status : Not yet recruiting
First Posted : February 22, 2018
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
First Affiliated Hospital of Fujian Medical University
Central South University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Tang-Du Hospital
First Affiliated Hospital of Harbin Medical University
First Hospital of Jilin University
The First Affiliated Hospital of Dalian Medical University
Shanxi Province Cardiovascular Hospital
Qilu Hospital of Shandong University
First Affiliated Hospital of Wenzhou Medical University
Shandong Provincial Hospital
Yantai Yuhuangding Hospital
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Ning Wang, Xuanwu Hospital, Beijing

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.


Condition or disease Intervention/treatment Phase
Hypothermia Aneurysmal Subarachnoid Hemorrhage Procedure: Zoll 2000 and/or CureWrap 3500 cooling system Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hypothermia

Arm Intervention/treatment
Experimental: 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.
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.

Placebo Comparator: northermia
normal physical cooling methods,like ice bag, conditionally required.
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.




Primary Outcome Measures :
  1. Neurological function [ Time Frame: 6 months after hemorrhage ]
    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.


Secondary Outcome Measures :
  1. Intracranial pressure [ Time Frame: Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, until the monitor is removed ]
    The effect of long-term hypothermia on ICP control will be determined.

  2. Length of ICU stay [ Time Frame: 6 months post hemorrhage ]
    The numbers of days in the ICU

  3. Length of hospital stay [ Time Frame: 6 months post hemorrhage ]
    The numbers of days in the hospital.

  4. Frequency of complications [ Time Frame: 6 months post hemorrhage ]
    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.

  5. Mortality rate [ Time Frame: 6 months after hemorrhage ]
    The proportion of death will be determined



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442608


Contacts
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Contact: Xin Qu, MD,PhD 86-10-83198633 xinqu0213@126.com

Sponsors and Collaborators
Xuanwu Hospital, Beijing
First Affiliated Hospital of Fujian Medical University
Central South University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Tang-Du Hospital
First Affiliated Hospital of Harbin Medical University
First Hospital of Jilin University
The First Affiliated Hospital of Dalian Medical University
Shanxi Province Cardiovascular Hospital
Qilu Hospital of Shandong University
First Affiliated Hospital of Wenzhou Medical University
Shandong Provincial Hospital
Yantai Yuhuangding Hospital
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Ning Wang, MD,PhD Xuanwu Hospital,Capital Medical University, Beijing

Publications:
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Responsible Party: Ning Wang, Professor, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03442608     History of Changes
Other Study ID Numbers: LTHSAH-1
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Hypothermia
Subarachnoid Hemorrhage
Pathologic Processes
Body Temperature Changes
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases