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Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke

NCT05779176 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2023-03-22

No results posted yet for this study

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).

Conditions

  • Stroke, Ischemic

Interventions

PROCEDURE

Therapeutic hypothermia

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Liqun Yang, Ph.D. · Renji Hospital, Shanghai Jiao Tong University School of Moedicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-06-30
Completion
2024-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779176 on ClinicalTrials.gov