Preliminary report of the clot lysis evaluating accelerated resolution of intraventricular hemorrhage (CLEAR-IVH) clinical trial.
Preliminary report of the clot lysis evaluating accelerated resolution of intraventricular hemorrhage (CLEAR-IVH) clinical trial.
复制标题
DOI：
10.1007/978-3-211-09469-3_41
复制
发表时间：
2008
期刊：
影响因子：
--
通讯作者：
Timothy C. Morgan;I. Awad;P. Keyl;K. Lane;D. Hanley
中科院分区：
文献类型：
--
作者：
Timothy C. Morgan;I. Awad;P. Keyl;K. Lane;D. Hanley
简介脑出血是最常见的致命性中风形式，并且是所有中风亚型中发病率最高的。对于同时患有脑出血和脑室内出血 (IVH) 的患者，预期死亡率为 50-80%。目前尚无针对人类的经过验证、有效的治疗方法，但动物模型证明了与从心室或脑内位置快速、近乎完全去除血液（即在 48 小时内去除约 80%）相关的实质性生理和功能益处。 CLEAR-IVH 试验（A 部分和 B 部分）的目的是评估使用多次注射低剂量 rt-PA 来加速 IVH 溶解和排空的安全性和有效性。方法参加试验的患者每 8 小时通过心室外引流注射 1.0mg rt-PA，最多 12 剂，或直到血栓减少或达到临床终点。每天进行 CT 扫描以监测血栓溶解并检查是否有意外出血事件。在之前的剂量探索研究中，安全性（症状再出血）为 0%，每 8 小时 1 mg rt-PA 被确定为适当剂量。 结果目前正在对最近完成的 CLEAR-IVH B 部分中的 36 名患者进行综合分析。不良事件在安全限度内，包括30天死亡率8%；有症状的再出血，8%；和细菌性脑室炎，0%。 结论初步分析表明，使用低剂量 rt-PA 可以安全地给予稳定的 IVH 凝块，并可能提高溶解率。
IntroductionBrain hemorrhage is the most frequent fatal form of stroke and has the highest level of morbidity of any stroke subtype. For patients with both intracerebral hemorrhage and intraventricular hemorrhage (IVH), expected mortality is 50-80%. No validated, efficacious treatment exists for humans, but animal models demonstrate substantial physiologic and functional benefits associated with rapid, near-complete removal of blood from either the ventricle or intracerebral location (i.e., ~80% removal over 48 h). The purpose of the CLEAR-IVH trial (Parts A and B) is to evaluate safety and efficacy of using multiple injections of low-dose rt-PA to accelerate lysis and evacuation of IVH.MethodsPatients enrolled in the trial receive an injection of 1.0mg rt-PA through an external ventricular drain every 8 h up to 12 doses, or until clot reduction or clinical endpoint is met. CT scans are taken daily to monitor clot resolution and check for unexpected bleeding events. In a previous dose-finding study where the safety profile (symptomatic re-bleeding) was 0%, 1 mg rt-PA every 8 h was determined the appropriate dose.ResultsComprehensive analyses of 36 patients in the recently completed CLEAR-IVH Part B are currently being conducted. Adverse events are within safety limits, including 30-day mortality, 8%; symptomatic re-bleeding, 8%; and bacterial ventriculitis, 0%.ConclusionPreliminary analyses show that use of low-dose rt-PA can be safely administered to stable IVH clots and may increase lysis rates.