A multicenter, randomized, double-blinded, placebo-controlled phase III study of Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage (CLEAR III).
A multicenter, randomized, double-blinded, placebo-controlled phase III study of Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage (CLEAR III).
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DOI：
10.1111/ijs.12097
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发表时间：
2014-06
期刊：
影响因子：
--
通讯作者：
CLEAR III Investigators
中科院分区：
文献类型：
--
作者：
Ziai WC;Tuhrim S;Lane K;McBee N;Lees K;Dawson J;Butcher K;Vespa P;Wright DW;Keyl PM;Mendelow AD;Kase C;Wijman C;Lapointe M;John S;Thompson R;Thompson C;Mayo S;Reilly P;Janis S;Awad I;Hanley DF;CLEAR III Investigators
在成人中，使用组织纤溶酶原激活剂（rt-PA）的脑室内溶栓治疗有助于解决脑室出血（IVH），降低颅内压，缩短CSF分流的持续时间，并可能改善继发于阻塞性脑积水的直接神经损伤。我们假设，与安慰剂相比，脑实质血肿体积较小（ICH vol < 30 cc）且IVH相对较大导致急性梗阻性脑积水的患者，在注射低剂量t-PA以加速IVH溶解和排空时，临床结局会有所改善。CLEAR III试验是一项比较使用脑室外引流（EVD）联合脑室内注射rt-PA治疗脑室外引流与脑室内注射生理盐水（安慰剂）治疗脑室内出血的III期、随机、多中心、双盲、安慰剂对照研究。在CT扫描确认IVH和第三或第四脑室梗阻的24小时内具有已知症状发作的患者，伴有或不伴有幕上脑内出血（ICH）体积< 30 cc，需要EVD的患者在放置EVD后至少6小时进行CT扫描筛选，如果必要，连续12小时间隔直至确定任何颅内出血稳定。符合临床和影像学标准（无持续性凝血障碍，且无动脉瘤、动静脉畸形（AVM）或任何其他血管异常的可疑症状）的患者将被随机分配至脑室内组织纤溶酶原激活剂组或安慰剂组。主要结局指标为第180天时的二分改良兰金量表（mRS）0-3 vs. 4-6。临床次要结局包括第180天时的额外mRS二分（0-4 vs. 5-6）、顺序mRS（0 - 6）、第30天时的死亡率和安全性事件、第180天时的死亡率、功能状态指标、ICU管理的类型和强度、心室血凝块清除率和程度以及生活质量指标。
In adults, intraventricular thrombolytic therapy with tissue plasminogen activator (rt-PA) facilitates resolution of intraventricular hemorrhage (IVH), reduces intracranial pressure, decreases duration of CSF diversion and may ameliorate direct neural injury secondary to obstructive hydrocephalus. We hypothesize that patients with small parenchymal hematoma volumes (ICH vol < 30 cc), and relatively large IVH causing acute obstructive hydrocephalus would have improved clinical outcomes when given injections of low-dose t-PA to accelerate lysis and evacuation of IVH compared to placebo. The CLEAR III trial is an investigator-initiated, phase III, randomized, multicenter, double-blind, placebo-controlled study comparing the use of external ventricular drainage (EVD) combined with intraventricular injection of rt-PA to EVD versus intraventricular injection of normal saline (placebo) for the treatment of IVH. Patients with known symptom onset within 24 hours of the CT scan confirmed IVH and third or fourth ventricle obstruction, with or without supratentorial intracerebral hemorrhage (ICH) volume < 30 cc, who require an EVD are screened with a CT scan at least 6 hours after EVD placement and, if necessary, at consecutive 12 hour intervals until stabilization of any intracranial bleeding has been established. Patients who meet clinical and imaging criteria (no ongoing coagulopathy and no suspicion of aneurysm, arteriovenous malformation (AVM), or any other vascular anomaly) will be randomized to either intraventricular tissue plasminogen activator or placebo. The primary outcome measure is dichotomized modified Rankin Scale (mRS) 0–3 vs. 4–6 at 180 days. Clinical secondary outcomes include additional mRS dichotomizations at 180 days (0–4 vs. 5–6), ordinal mRS (0 – 6), mortality and safety events at 30 days, mortality at 180 days, functional status measures, type and intensity of ICU management, rate and extent of ventricular blood clot removal, and quality of life measures.
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影响因子：
8.3
作者：
Naff N;Williams MA;Keyl PM;Tuhrim S;Bullock MR;Mayer SA;Coplin W;Narayan R;Haines S;Cruz-Flores S;Zuccarello M;Brock D;Awad I;Ziai WC;Marmarou A;Rhoney D;McBee N;Lane K;Hanley DF Jr
通讯作者：
Hanley DF Jr
影响因子：
4.8
作者：
Naff, NJ;Hanley, DF;Schmutzhard, E
通讯作者：
Schmutzhard, E
影响因子：
2.8
作者：
AKDEMIR, H;SELCUKLU, A;KAVUNCU, I
通讯作者：
KAVUNCU, I
影响因子：
2.4
作者：
Lee, KR;Betz, AL;Hoff, JT
通讯作者：
Hoff, JT
影响因子：
4.1
作者：
ELLINGTON E;MARGOLIS G
通讯作者：
MARGOLIS G