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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normothermia arm | No Intervention | Patients randomized to normothermia will be maintained at 36-37°C during the entire study period. | |
| Therapeutic hypothermia arm | Experimental | Patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic hypothermia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological function prognosis | the score on the modified Rankin Scale, seven grades ranked from 0 to 6, higher scores mean worse outcome | 90±14 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90±14 days post-operation |
| Incidence of intracranial hemorrhage and symptomatic intracranial hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liqun Yang, Ph.D. | Contact | +8615921969001 | lqyang72721@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liqun Yang, Ph.D. | Renji Hospital, Shanghai Jiao Tong University School of Moedicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, Shanghai Jiao Tong University, School of Medicine | Shanghai | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33724327 | Background | 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. | |
| 28154096 | Background | 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. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
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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.
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This trial is open labeled, the treatment allocation is known to the treating physicians and the patients
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|
Radiological examination(CT or MRI) |
| 24-72 hours post-operation |
| Target vascular recanalization rate | Cerebral angiography | 24-72 hours post-operation |
| 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 | 7 days post-operation |
| Final infarct volume | CT scan | 7 days post-operation |
| Death in hospital & within 90 days | Death in 90 days | Within 90 days after admission |
| 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 | Within 7 days post-operation |
| Adverse events of hypothermia and rewarming | arrhythmia (atrial fibrillation, ventricular fibrillation), hypokalemia, Chilblains or pressure ulcers; Rewarming shock and hyperkalemia | Within 24 hours post-operation |
| 17529907 | Background | 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. |
| 8214747 | Background | 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. |
| 15721471 | Background | 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. |
| 11856793 | Background | 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. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |