HypothermiaNCT03442608
Trial of Long-term Therapeutic Hypothermia for Poor-grade Aneurysmal Subarachnoid Hemorrhage
A study testing Zoll 2000 and/or CureWrap 3500 cooling system in people with Hypothermia and Aneurysmal Subarachnoid Hemorrhage, run by Xuanwu Hospital, Beijing.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypothermia, Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Zoll 2000 and/or CureWrap 3500 cooling system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- GCS of 3 with bilateral fixed and dilated pupils;
- No spontaneous breathing or cardiac arrest at the scene of hemorrhage;
- No consent;
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Zoll 2000 and/or CureWrap 3500 cooling system
- Medical subject headings
- Hypothermia, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoll 2000 and/or CureWrap 3500 cooling systemProcedure or surgery
Device(Zoll 2000 and/or CureWrap 3500 cooling system),lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree.
| Study group | Role | What they receive |
|---|---|---|
| mild hypothermia | Experimental | Device: Zoll 2000 and/or CureWrap 3500 cooling system,lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree. Receives: Procedure: Zoll 2000 and/or CureWrap 3500 cooling system |
| northermia | Placebo comparator | normal physical cooling methods,like ice bag, conditionally required. Receives: Procedure: Zoll 2000 and/or CureWrap 3500 cooling system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after hemorrhage
Secondary outcomes (5)
Intracranial pressure
The effect of long-term hypothermia on ICP control will be determined.
Measured: Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, until the monitor is removed
Length of ICU stay
The numbers of days in the ICU
Measured: 6 months post hemorrhage
Length of hospital stay
The numbers of days in the hospital.
Measured: 6 months post hemorrhage
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.
Measured: 6 months post hemorrhage
Mortality rate
The proportion of death will be determined
Measured: 6 months after hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Central South University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Tang-Du Hospital, First Affiliated Hospital of Harbin Medical University, The First Hospital of Jilin University, The First Affiliated Hospital of Dalian Medical University, Shanxi Cardiovascular Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital of Wenzhou Medical University, Shandong Provincial Hospital, Yantai Yuhuangding Hospital, Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Ning Wang, Xuanwu Hospital, Beijing
- Investigators
- Ning Wang, MD,PhD, Principal investigator, Xuanwu Hospital,Capital Medical University, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442608
- Sponsor's protocol ID
- LTHSAH-1
- Status last verified
- Feb 2018
- First submitted
- 16 Jan 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19050656Qu 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.
PubMed 33987279
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03442608
- Acronym / sponsor ID
- LTHSAH-1
- Conditions
- Hypothermia, Aneurysmal Subarachnoid Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Central South University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Tang-Du Hospital, First Affiliated Hospital of Harbin Medical University, The First Hospital of Jilin University, The First Affiliated Hospital of Dalian Medical University, Shanxi Cardiovascular Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital of Wenzhou Medical University, Shandong Provincial Hospital, Yantai Yuhuangding Hospital, Beijing Tiantan Hospital
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild hypothermia | Experimental | Procedure: Zoll 2000 and/or CureWrap 3500 cooling systemDevice: Zoll 2000 and/or CureWrap 3500 cooling system,lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree. |
| northermia | Placebo comparator | Procedure: Zoll 2000 and/or CureWrap 3500 cooling systemnormal physical cooling methods,like ice bag, conditionally required. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- GCS of 3 with bilateral fixed and dilated pupils;
- No spontaneous breathing or cardiac arrest at the scene of hemorrhage;
- No consent;
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoll 2000 and/or CureWrap 3500 cooling systemDevice(Zoll 2000 and/or CureWrap 3500 cooling system),lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree. | Procedure or surgery | mild hypothermia, northermia |
Primary outcome
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.
5 secondary outcomes
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
Length of ICU stay
Time frame: 6 months post hemorrhage
Length of hospital stay
Time frame: 6 months post hemorrhage
Frequency of complications
Time frame: 6 months post hemorrhage
Mortality rate
Time frame: 6 months after hemorrhage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Background: PubMed 19050656Seule 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.
- Derived from this study: PubMed 33987279Qu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Wang, MD,PhD principal investigator
Xuanwu Hospital,Capital Medical University, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing Zoll 2000 and/or CureWrap 3500 cooling system in people with Hypothermia and Aneurysmal Subarachnoid Hemorrhage, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Qu, MD,PhD (86-10-83198633, xinqu0213@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological function (time frame: 6 months after hemorrhage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03442608, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.