Assessing Local Hypothermia and Endovascular Recanalization for Acute Stroke With a Large Core Infarction-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 322
- 主要终点
- Proportion of patients with modified Rankin Score 0-2 at 90 days.
研究概览
简要总结
A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for acute patients with a Large Core Infarction.
详细描述
This trial aims to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for patients with acute patients with a Large Core Infarction. Participants were centrally randomized in a 1:1 ratio to either endovascular thrombectomy (EVT) combined with intra-arterial cold saline infusion (IA-CSI) (hypothermia group) or EVT combined with normothermic saline infusion (normothermia group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria：
- •Age ≥18 years old.
- •The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
- •Time from symptom onset to randomization ≤24h.
- •Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and are capable of receiving clinical follow-up.
- •Specific Neuroimaging Inclusion Criteria
- •Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment).
- •NCCT ASPECTS value of 3 to 5 based on findings from non-contrast CT within 24 hours after stroke onset (defined as the time the patient was last known to be well), with no limitation with respect to infarct-core volume;
- •NCCT ASPECTS value of 0 to 2 based on findings from non-contrast CT within 24 hours after stroke onset and an infarct-core volume between 70 ml and 100 ml;
- •NCCT ASPECTS value greater than 5 based on findings from non-contrast CT after stroke onset and an infarct-core volume of 70 to 100 ml.
排除标准
- •Pre stroke mRS>1 score.
- •Multivessel Occlusion
- •Concomitant untreated intracranial aneurysms, intracranial tumors (with the exception of small meningiomas), or intracranial vascular malformations.
- •History of intracranial hemorrhage within 6 months, including parenchymal hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
- •History of gastrointestinal hemorrhage, genitourinary bleeding, acute myocardial infarction (AMI), cranial trauma, or having undergone major surgical procedures within the past month.
- •The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (platelet count < 40,000 /μl, uncorrected INR>2.0).
- •Patients with heart function of grade 1 or above, or with a clear history of acute or chronic heart dysfunction, are at greater risk of acute heart failure or fluid perfusion intolerance as determined by clinicians.
- •Severe heart, liver, kidney disease.
- •Known allergy to contrast media or related medications.
- •Refractory hypertension uncontrolled by medication (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg).
- •glucose <2.8 mmol/L or >22.2 mmol/L；
- •Pregnancy or lactation；
- •the expected survival time is less than 12 months.
- •Participating in other clinical trials, in the investigational phase or in the follow-up phase.
- •Other conditions deemed by investigators to pose significant risks or render participation unsuitable (e.g. inability to comply due to psychiatric/cognitive/emotional disorders).
研究组 & 干预措施
Normothermial group
In the contral group, after crossing the occluded vessel segment with a microcatheter and confirming its location in the true lumen, roomtemperature saline will be extracted from the refrigerator. 50ml will be drawn within 2 minutes and then continuously infused at a rate of 10ml/min using an infusion pump. After infusion, standard thrombectomy procedures will be performed. After completion of the thrombectomy procedure (regardless of achieving 2b/3-grade reperfusion), another roomtemperature 300ml of saline will be extracted within 2 minutes and infused at a rate of 30ml/min for 10 minutes through the intermediate catheter or guiding catheter placed in the internal carotid artery.
干预措施: Control (Normal saline) (Other)
Hypothermia group
In the treatment group, after crossing the occluded vessel segment with a microcatheter and confirming its location in the true lumen, 4℃-saline will be extracted from the refrigerator. 50ml will be drawn within 2 minutes and then continuously infused at a rate of 10ml/min using an infusion pump. After infusion, standard thrombectomy procedures will be performed. After completion of the thrombectomy procedure (regardless of achieving 2b/3-grade reperfusion), another 300ml of saline will be extracted within 2 minutes and infused at a rate of 30ml/min for 10 minutes through the intermediate catheter or guiding catheter placed in the internal carotid artery. Post-infusion, contrast-enhanced cerebral angiography using room temperature contrast agent is generally not recommended to dilute the local temperature.
干预措施: intra-arterial local therapeutic hypothermia (Other)
结局指标
主要结局
Proportion of patients with modified Rankin Score 0-2 at 90 days.
时间窗: 90±7 days after randomization
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
次要结局
- Neurofunctional deficit defined as modified Rankin Scale (mRS)(90±7 days after randomization)
- Proportion of patients with modified Rankin Score 0-1 at 90 days(90±7 days after randomization)
- Proportion of patients with modified Rankin Score 0-3 at 90 days.(90±7 days after randomization)
- Rate of symptomatic intracranial hemorrhage within 48 hours (Heidelberg Bleeding Classification)(within 48±12 hours after randomization)
- All-Cause Mortality within 90 (±7) Days Post-Randomization(90±7 days after randomization)
- Any type of intracranial hemorrhage according to Heidelberg Classification.(within 48±12 hours after randomization)
- Incidence rate of malignant cerebral edema within 72 (±48) hours post-randomization(72 (±48) hours post-randomization)