NCT04554797Unknown不适用
Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke
Capital Medical University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of any major adverse events
研究概览
简要总结
The investigators have previous shown that regional hypothermia by the intra-arterial infusion of cold saline combined with mechanical thrombectomy in acute ischemic stroke is feasible and safe. The safety of selective brain cooling in patients undergoing mechanical thrombectomy, however, is not established in a randomized trial. The investigators therefore conducted this RCT study to further explore the safety of regional hypothermia in patients with acute ischemic stroke who underwent mechanical thrombectomy.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤80
- •Clinical signs consistent with the diagnosis of an acute ischemic stroke
- •Baseline NIHSS score obtained prior to randomization ≥8
- •Intracranial arterial occlusion of the distal intracranial carotid artery or
- •Middle (M1/M2), demonstrated with CTA, MRA, DSA
- •The possibility to start treatment (artery puncture) within 6 hours from onset
- •Regional hypothermia is expected to start within 15 minutes after recanalization
- •Informed consent given
排除标准
- •mTICI<2b after endovascular treatment
- •No significant pre-stroke disability (mRS ≤1)
- •Previous NYHA grade > 1
- •Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- •Baseline platelet count < 50000/µL
- •Baseline blood glucose of < 50mg/dL or >400mg/dl
- •Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg). NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using local treatment guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
- •Seizures at stroke onset which would preclude obtaining a baseline NIHSS
- •Subjects who have received iv t-PA treatment beyond 4,5 hours from the beginning of the symptoms
- •Renal insufficiency with creatinine ≥ 3 mg/dl
- •Woman of childbearing potential who is known to be pregnant or lactating
- •Subject participating in a study involving an investigational drug or device that would impact this study
- •Cerebral vasculitis
- •Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- •Unlikely to be available for 3 months follow-up (e.g. no fixed home address, visitor from overseas).
- •CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed)
- •ASPECT<6
- •Subjects with occlusions in multiple vascular territories (anterior circulation and posterior circulation)
- •Evidence of intracranial tumor (except small meningioma)
结局指标
主要结局
Rate of any major adverse events
时间窗: 7 days
次要结局
- Rate of symptomatic intracerebral hemorrhage(24 hours)
- NIHSS(7 days or discharge)
- Final infarct volume(5-7 days)
- Modified Rankin scale(90 days)
- Rate of intracerebral hemorrhage(24 hours)
- Rate of death(90 days)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University
研究点 (2)
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