Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05779176
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-22
First Post:
2023-02-23
Brief Title:
Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy a Prospective Randomized Controlled Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THIS
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 05 C every 4 h Whats more patients in TH group will execute anti-shivering protocol during awaking and extubation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None