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Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke (THIS)

Primary Purpose

Stroke, Ischemic

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Therapeutic hypothermia
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Therapeutic hypothermia, AIS, Neurological function prognosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Normothermia arm

Therapeutic hypothermia arm

Arm Description

Patients randomized to normothermia will be maintained at 36-37°C during the entire study period.

Patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Incidence of intracranial hemorrhage and symptomatic intracranial hemorrhage
Radiological examination(CT or MRI)
Target vascular recanalization rate
Cerebral angiography
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
Final infarct volume
CT scan
Death in hospital & within 90 days
Death in 90 days
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
Adverse events of hypothermia and rewarming
arrhythmia (atrial fibrillation, ventricular fibrillation), hypokalemia, Chilblains or pressure ulcers; Rewarming shock and hyperkalemia

Full Information

First Posted
February 23, 2023
Last Updated
March 19, 2023
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05779176
Brief Title
Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke
Acronym
THIS
Official Title
Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy: a Prospective, Randomized, Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Therapeutic hypothermia, AIS, Neurological function prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
This trial is open labeled, the treatment allocation is known to the treating physicians and the patients
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normothermia arm
Arm Type
No Intervention
Arm Description
Patients randomized to normothermia will be maintained at 36-37°C during the entire study period.
Arm Title
Therapeutic hypothermia arm
Arm Type
Experimental
Arm Description
Patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C
Intervention Type
Procedure
Intervention Name(s)
Therapeutic hypothermia
Intervention 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 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.
Primary Outcome Measure Information:
Title
Neurological function prognosis
Description
the score on the modified Rankin Scale, seven grades ranked from 0 to 6, higher scores mean worse outcome
Time Frame
90±14 days post-operation
Secondary Outcome Measure Information:
Title
Ratio of mRS score 2 or less
Description
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
Time Frame
90±14 days post-operation
Title
Incidence of intracranial hemorrhage and symptomatic intracranial hemorrhage
Description
Radiological examination(CT or MRI)
Time Frame
24-72 hours post-operation
Title
Target vascular recanalization rate
Description
Cerebral angiography
Time Frame
24-72 hours post-operation
Title
NIHSS score
Description
The score of National Institute of Health stroke scale, NIHSS score ranked from 0 to 42, higher scores mean a worse neurological outcome
Time Frame
7 days post-operation
Title
Final infarct volume
Description
CT scan
Time Frame
7 days post-operation
Title
Death in hospital & within 90 days
Description
Death in 90 days
Time Frame
Within 90 days after admission
Title
The incidence of adverse event
Description
Surgery-related complications: vascular perforation, arterial dissection, and distal embolization;Incidence of pneumonia within 7 days; Incidence of deep vein thrombosis within 7 days
Time Frame
Within 7 days post-operation
Title
Adverse events of hypothermia and rewarming
Description
arrhythmia (atrial fibrillation, ventricular fibrillation), hypokalemia, Chilblains or pressure ulcers; Rewarming shock and hyperkalemia
Time Frame
Within 24 hours post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liqun Yang, Ph.D.
Phone
+8615921969001
Email
lqyang72721@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liqun Yang, Ph.D.
Organizational Affiliation
Renji Hospital, Shanghai Jiao Tong University School of Moedicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33724327
Citation
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.
Results Reference
background
PubMed Identifier
28154096
Citation
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.
Results Reference
background
PubMed Identifier
17529907
Citation
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.
Results Reference
background
PubMed Identifier
8214747
Citation
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.
Results Reference
background
PubMed Identifier
15721471
Citation
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.
Results Reference
background
PubMed Identifier
11856793
Citation
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. Erratum In: N Engl J Med 2002 May 30;346(22):1756.
Results Reference
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Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke

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