Resolution of intraventricular hemorrhage varies by ventricular region and dose of intraventricular thrombolytic: the Clot Lysis: Evaluating Accelerated Resolution of IVH (CLEAR IVH) program.

Resolution of intraventricular hemorrhage varies by ventricular region and dose of intraventricular thrombolytic: the Clot Lysis: Evaluating Accelerated Resolution of IVH (CLEAR IVH) program.
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DOI:
10.1161/strokeaha.112.650523
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发表时间:
2012-06
期刊:
影响因子:
8.3
通讯作者:
Hanley DF
Hanley DF
中科院分区:
医学1区
文献类型:
--
作者:
Webb AJ;Ullman NL;Mann S;Muschelli J;Awad IA;Hanley DF

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CLEAR-IVH项目正在评估脑室内重组组织纤溶酶原激活剂(rtPA)治疗自发性脑室内出血(IVH)的疗效。该亚组分析评估了不同地区rtPA剂量对IVH清除率的影响。64例自发性IVH 12 - 24小时内的患者随机接受安慰剂、0.3mg、1mg或3mg rtPA,每日两次,通过脑室外引流。心室的12个亚区从0 - 4评分。通过生存分析,比较所有地区合并和亚区域的剂量对IVH清除至基线评分50%(t50)的影响。采用Cox比例风险法对模型进行比较,包括心室区域、剂量和基线评分。随着rtPA剂量的增加,所有区域的IVH评分降低更快(t50:对数秩p <0.0001;安慰剂-11.43天,95%CI 5.68 - 17.18; 0.3mg-3.19天,1.00 - 5.38; 1mg-3.54天,0.45 - 6.64; 3mg-2.59天,1.72 - 3.46)。在联合模型中,剂量和基线评分与IVH评分降低独立相关,其中中线脑室最快,然后是侧脑室的前半部分,最慢的是侧脑室的后半部分(t50:p <0.0001; rtPA剂量:HR = 1.47,1.30 - 1.67;中线与前外侧HR = 1.71,1.08 - 2.71;中线与后外侧HR = 4.05,2.46 - 6.65;基线评分HR = 0.96,0.91 - 1.01),剂量和心室区域之间存在显著相互作用(p = 0.005)。rtPA加速脑室内出血的消退。这种效应是剂量依赖性的,在中线脑室中最大,在后侧脑室中最小。http://www.clinicaltrials.gov
The CLEAR-IVH program is assessing the efficacy of intraventricular recombinant tissue Plasminogen Activator (rtPA) for spontaneous intraventricular hemorrhage (IVH). This subanalysis assesses the effect of dose of rtPA by region on clearance of IVH. Sixty-four patients within 12–24 hours of spontaneous IVH were randomized to placebo, 0.3mg, 1mg or 3mg of rtPA twice daily via an extraventricular drain. Twelve subregions of the ventricles were scored from 0–4. Effect of dose on IVH clearance to 50% (t50) of baseline score was compared by survival analysis for all regions combined and by subregion. Models including ventricular region, dose and baseline score were compared by Cox-Proportional Hazards. IVH score reduced faster across all regions with increasing rtPA dose (t50: log-rank p<0.0001; placebo-11.43 days, 95%CI 5.68–17.18; 0.3mg– 3.19d, 1.00–5.38; 1mg– 3.54d, 0.45–6.64; 3mg– 2.59d, 1.72–3.46). In the combined models, dose and baseline score were independently associated with reduction in IVH score, which was quickest in the midline ventricles, then the anterior half of the lateral ventricles and slowest in the posterior half of the lateral ventricles (t50: p<0.0001; rtPA dose: HR=1.47, 1.30–1.67; midline vs anterior-lateral HR=1.71, 1.08–2.71; midline vs posterior-lateral HR=4.05, 2.46–6.65; baseline score HR=0.96, 0.91–1.01), with a significant interaction between dose and ventricular region (p=0.005). rtPA accelerates resolution of intraventricular hemorrhage. This effect is dose-dependent, is greatest in the midline ventricles and least in the posterior-lateral ventricles. http://www.clinicaltrials.gov: NCT00650858.