Local Hypothermia and Endovascular Recanalization for Acute Large Artery Occlusive Stroke-A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 262
- 试验地点
- 1
- 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 patients with acute anterior circulation large artery occlusion.
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 anterior circulation large artery occlusion. This study used a stratified randomization method, with participants randomly allocated in a 1:1 ratio by a central network randomization system to either the mechanical thrombectomy (MT) combined with arterial selective cooling infusion (intravenous recombinant tissue plasminogen activator) (hypothermia) group or the MT combined with normal saline infusion (normothermia) group (hereinafter referred to as the hypothermia group or normothermia group). Randomization was stratified by ASPECTS score (≥8 or <8) and age (≥75 years or <75 years).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤85 years old.
- •Symptoms of sudden focal or general neurological impairment.
- •There may be a causal relationship between vascular occlusion and nerve function defect.
- •Time from symptom onset to randomization ≤24h.
- •The National Institutes of Health Stroke Scale (NIHSS) score was ≥6 points before randomization.
- •According to the judgment of the clinician, the operation path is reasonable, and the operation and operation related instruments can reach the disease smoothly.
- •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.
- •Prior to randomization, CTA, MRA, or DSA confirmed the presence of anterior circulatory large vessel occlusion (internal carotid artery or M1segment).
- •The symptoms are aggravated by recurrent cerebral infarction in the same drainage basin and/or the pathogenesis is caused by decreased blood perfusion.
排除标准
- •Pre stroke mRS>1 score.
- •There are acute infarcts in both cerebral hemispheres and/or anterior and posterior circulation.
- •NIHSS≤6 points.
- •Cerebral hemorrhage/subarachnoid hemorrhage was confirmed by CT or MRI. 5.The presence of active bleeding, severe anemia, coagulation dysfunction, or an uncorrected bleeding tendency (Presence of at least one of the following laboratory tests: hemoglobin < 10g /dl, platelet count < 100,000 /μl, uncorrected INR>1.5, PT> 1 minute above the upper limit of normal, or heparin-related thrombocytopenia).
- •6.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. 8.With malignant diseases such as malignant tumors, the expected survival time is less than 3 months.
- •9.Participating in other clinical trials, in the investigational phase or in the follow-up phase.
研究组 & 干预措施
Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
干预措施: Mechanical thrombectomy (Procedure)
Mechanical thrombectomy combined with intra-arterial selective cooling infusion (hypothermia) group
Patients received a total of 350 ml of 4°C saline infusion in addition to mechanical thrombectomy (MT).
干预措施: 4°C saline infusion (Drug)
Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
干预措施: Mechanical thrombectomy (Procedure)
Mechanical thrombectomy combined with normothermic saline infusion (normothermia) group
Patients received a total of 350 ml of roomtemperature saline infusion in addition to mechanical thrombectomy (MT).
干预措施: Normothermic saline infusion (Drug)
结局指标
主要结局
Proportion of patients with modified Rankin Score 0-2 at 90 days.
时间窗: 90 days after procedure
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
- Proportion of patients with modified Rankin Score 0-1 at 90 days(90 days after procedure)
- Successful reperfusion rate(At the end of the operation)
- Cerebral infarction volume was measured by CT or magnetic resonance DWI 72 hours to 7 days after operation(72 hours to 7 days after procedure)
- Rate of recurrent occlusion on MRA or CTA (postoperative 24 Hours to 7 Days)(postoperative 24 Hours to 7 Days)
- Incidence of early neurological deterioration(Within 24 hours after procedure)
研究者
Zhixin Huang
Principal Investigator
Guangdong Second Provincial General Hospital