Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2).
Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2).
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DOI：
10.1161/strokeaha.116.014200
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发表时间：
2016-12
期刊：
影响因子：
8.3
通讯作者：
Collaborators
中科院分区：
文献类型：
--
作者：
Lyden P;Hemmen T;Grotta J;Rapp K;Ernstrom K;Rzesiewicz T;Parker S;Concha M;Hussain S;Agarwal S;Meyer B;Jurf J;Altafullah I;Raman R;Collaborators
治疗性低温（TH）是一种有效的神经保护剂，被批准用于新生儿缺氧缺血和心脏骤停后的脑保护。TH治疗急性缺血性脑卒中的先导性试验是安全可行的。我们设计了一个研究方案，为中风患者提供更安全，更快的TH。在急性卒中血管内冷却治疗（ICTuS）试验方案中增加了安全程序和4°C盐水输注以加快冷却。合格患者静脉注射rt-PA后，股静脉血管内冷却导管提供24小时冷却，随后12小时复温。进行了系列安全性评估和成像。主要终点为3个月改良兰金评分0.1。在预期的1600例受试者中，120例在研究停止前入组。随机选择63例接受低温（HY）加抗寒战治疗，57例接受常温（NT）治疗。与之前的研究相比，冷盐水推注改善了冷却速率，没有液体过载。33% HY和38% NT受试者的90天mRS 0.1的意向治疗主要结局，OR（95% CL）为0.81（0.36，1.85）。严重不良事件的发生率相同。HY和NT受试者的死亡率分别为15.9%和8.8%，OR（95% CL）为1.95（0.56，7.79）。19% HY受试者和10.5% NT受试者发生肺炎，OR（95% CL）为1.99（0.63，6.98）。经血管内TH治疗急性缺血性脑卒中安全可行。旨在降低肺炎风险的方案变化似乎失败了，尽管样本很小。clinicaltrials.gov NCT 01123161。
Therapeutic hypothermia (TH) is a potent neuroprotectant approved for cerebral protection after neonatal hypoxia-ischemia and cardiac arrest. TH for acute ischemic stroke is safe and feasible in pilot trials. We designed a study protocol to provide safer, faster TH in stroke patients. Safety procedures and 4°C saline infusions for faster cooling were added to the Intravascular Cooling Treatment in Acute Stroke (ICTuS) trial protocol. A femoral venous intravascular cooling catheter following intravenous rt-PA in eligible patients provided 24 hours cooling followed by a 12 hour re-warm. Serial safety assessments and imaging were performed. The primary endpoint was 3-month modified Rankin score 0,1. Of the intended 1600 subjects, 120 were enrolled before the study was stopped. Randomly, 63 were to receive hypothermia (HY) plus anti-shivering treatment and 57 normothermia (NT). Compared to prior studies, cooling rates were improved with a cold saline bolus, without fluid overload. The intention-to-treat primary outcome of 90-day mRS 0,1 occurred in 33% HY and 38% NT subjects, OR (95% CL) of 0.81 (0.36, 1.85). Serious adverse events occurred equally. Mortality was 15.9% HY and 8.8% NT subjects, OR (95% CL) of 1.95 (0.56, 7.79). Pneumonia occurred in 19% HY vs. 10.5% in NT subjects, OR (95% CL) of 1.99 (0.63, 6.98). Intravascular TH was confirmed to be safe and feasible in rt-PA treated acute ischemic stroke patients. Protocol changes designed to reduce pneumonia risk appeared to fail, although the sample is small. clinicaltrials.gov NCT 01123161.