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Stroke, IschemicTHISNCT05779176

Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke

A study testing Therapeutic hypothermia in people with Stroke, Ischemic, run by RenJi Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Therapeutic hypothermia (TH) in stroke has demonstrated robust neuroprotection in animals especially after ischemia-reperfusion injury, but its safety and efficacy remain controversial. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke, Ischemic
What is being tested?
Therapeutic hypothermia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteChina
Study dates
1 May 2023to 31 Oct 2024
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-85 years(inclusive);
  • Patients have clinical signs consistent with acute ischemic stroke,
  • Patients with acute large vessel occlusion including internal carotid artery and middle cerebral artery M1 and M2 demonstrated by CTA，MRA or DSA
  • The possibility to receive arterial thrombus removal treatment （within6 or24 hr of large vessel occlusion ）;
  • Provide the informed consent form of the patient or the patient's agent.

Who cannot join

  • Coma or altered vigilance defined as a score ≥2 on the level of consciousness 1A subscale of the NIHSS.
  • Associated cerebral hemorrhage.
  • There is dysfunction before the onset, mRS score >= 2 points;
  • Accompanied by severe comorbidities (such as severe cardiopulmonary insufficiency, the expected survival period of advanced malignant tumors is less than 90 days);
  • Multi-mode CT/MRI examination of the corresponding contrast agent use contraindications (such as contrast agent allergy, etc.);
  • Women during pregnancy or lactation;
  • Patients currently participating in other clinical research trials;
  • Other conditions judged by the investigator as not suitable for inclusion in the clinical study.

Trial locations and contacts

1 site in 1 country.

Liqun Yang, Ph.D. contact

+8615921969001

lqyang72721@126.com

China1 site

  • Renji Hospital, Shanghai Jiao Tong University, School of Medicine

    Shanghai, 200127

Other trials in China

About this study

Official title: Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy: a Prospective, Randomized, Controlled Clinical Study

Therapeutic hypothermia (TH) in stroke has demonstrated robust neuroprotection in animals especially after ischemia-reperfusion injury, but its safety and efficacy remain controversial. The investigators propose this trial to study the clinical and radiological effects of therapeutic hypothermia in acute ischemic stroke patients treated with intravascular thrombectomy (IVT).

Read the detailed description

The study intervention is therapeutic hypothermia. After intubation, patients assigned to therapeutic hypothermia will receive central venous catheterization through right jugular vein or femoral vein depending on the cooling application and the unique needs, a flexible catheter will be inserted and iced saline will be circulated through the multiple balloons of the catheter in a closed-loop design to induce therapeutic hypothermia. This system also has a hydrophilic coating with heparin and a triple-lumen central venous catheter to satisfy the need of fluid or drug infusion, blood draw and central venous pressure monitoring. After central venous catheterization, patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C, which is superior to surface methods in cooling performance in terms of faster rate of cooling, shorter induced cooling time, precise control during maintenance. Thereafter, hypothermia will be maintained for 24 hrs from the start of hypothermia. The patients will be rewarmed slowly at a rate of no greater than 0.5 °C every 4 h. What's more, patients in TH group will execute anti-shivering protocol during awaking and extubation.

Being tested
Therapeutic hypothermia
Keywords
Therapeutic hypothermia, AIS, Neurological function prognosis
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic hypothermiaProcedure or surgery

    The study intervention is therapeutic hypothermia. After intubation, patients assigned to therapeutic hypothermia will receive central venous catheterization through right jugular vein or femoral vein depending on the cooling application and the unique needs, a flexible catheter will be inserted and iced saline was circulated through the multiple balloons of the catheter in a closed-loop design to induce therapeutic hypothermia. This system also has a hydrophilic coating with heparin and a triple-lumen central venous catheter to satisfy the need of fluid or drug infusion, blood draw and central venous pressure monitoring. After central venous catheterization, patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C.

Study groups in NCT05779176
Study groupRoleWhat they receive
Normothermia armNo interventionPatients randomized to normothermia will be maintained at 36-37°C during the entire study period.
Therapeutic hypothermia armExperimentalPatients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C
Receives: Procedure: Therapeutic hypothermia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurological function prognosis

    the score on the modified Rankin Scale, seven grades ranked from 0 to 6, higher scores mean worse outcome

    Measured: 90±14 days post-operation

Secondary outcomes (8)

  1. Ratio of mRS score 2 or less

    the ratio of modified Rankin Scale score 2 or less, modified Rankin Scale has seven grades ranked from 0 to 6, higher scores mean worse outcome

    Measured: 90±14 days post-operation

  2. Incidence of intracranial hemorrhage and symptomatic intracranial hemorrhage

    Radiological examination（CT or MRI）

    Measured: 24-72 hours post-operation

  3. Target vascular recanalization rate

    Cerebral angiography

    Measured: 24-72 hours post-operation

  4. NIHSS score

    The score of National Institute of Health stroke scale, NIHSS score ranked from 0 to 42, higher scores mean a worse neurological outcome

    Measured: 7 days post-operation

  5. Final infarct volume

    CT scan

    Measured: 7 days post-operation

  6. Death in hospital & within 90 days

    Death in 90 days

    Measured: Within 90 days after admission

  7. The incidence of adverse event

    Surgery-related complications: vascular perforation, arterial dissection, and distal embolization；Incidence of pneumonia within 7 days; Incidence of deep vein thrombosis within 7 days

    Measured: Within 7 days post-operation

  8. Adverse events of hypothermia and rewarming

    arrhythmia (atrial fibrillation, ventricular fibrillation), hypokalemia, Chilblains or pressure ulcers; Rewarming shock and hyperkalemia

    Measured: Within 24 hours post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Resources

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
Model description
Safety and efficacy of therapeutic hypothermia in acute ischemic stroke (AIS) patients treated with Intravascular thrombectomy is a prospective, multi-center, randomized, parallel-group interventional study.
Masking
None (open label)
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05779176
Sponsor's protocol ID
RA-2022-180
Acronym
THIS
Status last verified
Mar 2023
First submitted
23 Feb 2023
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mendelson SJ, Prabhakaran S. Diagnosis and Management of Transient Ischemic Attack and Acute Ischemic Stroke: A Review. JAMA. 2021 Mar 16;325(11):1088-1098. doi: 10.1001/jama.2020.26867.

    PubMed 33724327

  • Feigin VL, Norrving B, Mensah GA. Global Burden of Stroke. Circ Res. 2017 Feb 3;120(3):439-448. doi: 10.1161/CIRCRESAHA.116.308413.

    PubMed 28154096

  • Chio CC, Kuo JR, Hsiao SH, Chang CP, Lin MT. Effect of brain cooling on brain ischemia and damage markers after fluid percussion brain injury in rats. Shock. 2007 Sep;28(3):284-90. doi: 10.1097/SHK.0b013e3180311e60.

    PubMed 17529907

  • Hynson JM, Sessler DI, Moayeri A, McGuire J. Absence of nonshivering thermogenesis in anesthetized adult humans. Anesthesiology. 1993 Oct;79(4):695-703. doi: 10.1097/00000542-199310000-00010.

    PubMed 8214747

  • Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet. 2005 Feb 19-25;365(9460):663-70. doi: 10.1016/S0140-6736(05)17946-X.

    PubMed 15721471

  • Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.

    PubMed 11856793

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic hypothermia in people with Stroke, Ischemic, run by RenJi Hospital at 1 site in China.

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 5 inclusion and 8 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 Liqun Yang, Ph.D. (+8615921969001, lqyang72721@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological function prognosis (time frame: 90±14 days post-operation). 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 NCT05779176, which also lists 6 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 22 Mar 2023.

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