Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke

Not Applicable

Not yet recruiting

• Conditions: Stroke, Ischemic
• Interventions: Procedure: Therapeutic hypothermia

• Registration Number: NCT05779176
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2023-02-23
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-19
• Last Update Submitted: 2023-03-19
• Study First Posted: 2023-03-22
• Last Update Posted: 2023-03-22
• Study Start: 2023-05-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic hypothermia arm	Therapeutic hypothermia	Patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C

Primary Outcome Measures

Name	Time	Method
Neurological function prognosis	90±14 days post-operation	the score on the modified Rankin Scale, seven grades ranked from 0 to 6, higher scores mean worse outcome

Secondary Outcome Measures

Name	Time	Method
Final infarct volume	7 days post-operation	CT scan
The incidence of adverse event	Within 7 days post-operation	Surgery-related complications: vascular perforation, arterial dissection, and distal embolization；Incidence of pneumonia within 7 days; Incidence of deep vein thrombosis within 7 days
Incidence of intracranial hemorrhage and symptomatic intracranial hemorrhage	24-72 hours post-operation	Radiological examination（CT or MRI）
NIHSS score	7 days post-operation	The score of National Institute of Health stroke scale, NIHSS score ranked from 0 to 42, higher scores mean a worse neurological outcome
Death in hospital & within 90 days	Within 90 days after admission	Death in 90 days
Adverse events of hypothermia and rewarming	Within 24 hours post-operation	arrhythmia (atrial fibrillation, ventricular fibrillation), hypokalemia, Chilblains or pressure ulcers; Rewarming shock and hyperkalemia
Ratio of mRS score 2 or less	90±14 days post-operation	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
Target vascular recanalization rate	24-72 hours post-operation	Cerebral angiography

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, China