Low-dose recombinant tissue-type plasminogen activator enhances clot resolution in brain hemorrhage: the intraventricular hemorrhage thrombolysis trial.
Low-dose recombinant tissue-type plasminogen activator enhances clot resolution in brain hemorrhage: the intraventricular hemorrhage thrombolysis trial.
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DOI：
10.1161/strokeaha.110.610949
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发表时间：
2011-11
期刊：
影响因子：
8.3
通讯作者：
Hanley DF Jr
中科院分区：
文献类型：
--
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
据报道，脑出血（ICH）和脑室内出血（IVH）患者的死亡率为50- 80%。我们评估了这些患者的溶栓治疗策略，包括死亡率、脑室感染和出血安全性事件，以及其对脑室内血栓溶解率的影响。48例患者在14个中心入组，并随机接受3 mg重组组织型纤溶酶原激活剂（rt-PA）或安慰剂治疗。比较两组的人口统计学特征、严重性因素、安全性结局（死亡率、感染、出血）和血栓消退率。严重程度因素，包括入院GCS、ICH体积、IVH体积和血压，均分布均匀，不良事件也是如此，除了安慰剂治疗组呼吸系统事件的频率增加。在就诊时、EVD闭合时或在活性治疗阶段，治疗组之间的ICP和脑灌注压（CPP）均无显著差异。死亡和脑室炎的频率显著低于预期，出血事件仍低于预先规定的阈值：死亡率（18%，rt-PA; 23%，安慰剂）;脑室炎（8%，rt-PA; 9%，安慰剂）;症状性出血（23%，rt-PA; 5%，安慰剂，接近统计学显著性（p=0.1））。rt-PA的中位给药持续时间为7.5天，安慰剂为12天。与安慰剂和既往历史对照相比，rt-PA对血凝块消退率具有显著的有益作用。低剂量rt-PA治疗ICH伴IVH具有可接受的安全性特征。需要来自精心设计的III期临床试验（如CLEAR III）的数据来全面评估这种治疗。受试者入组开始于2005年7月1日之前。
Patients with intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) have a reported mortality of 50–80%. We evaluated a clot lytic treatment strategy for these patients in terms of mortality, ventricular infection, and bleeding safety events and for its effect on the rate of intraventricular clot lysis. 48 Patients were enrolled at 14 centers and randomized to treatment with 3mg recombinant tissue plasminogen activator (rt-PA) or placebo. Demographic characteristics, severity factors, safety outcomes (mortality, infection, bleeding), and clot resolution rates were compared in the two groups. Severity factors, including admission GCS, ICH volume, IVH volume and blood pressure, were evenly distributed, as were adverse events except for an increased frequency of respiratory system events in the placebo-treated group. Neither ICP nor Cerebral Perfusion pressure (CPP) differed substantially between treatment groups on presentation, with EVD closure, or during the active treatment phase. Frequency of death and ventriculitis was substantially lower than expected and bleeding events remained below the pre-specified threshold: mortality (18%, rt-PA; 23%, placebo); ventriculitis (8%, rt-PA; 9%, placebo); symptomatic bleeding (23%, rt-PA; 5% placebo, which approached statistical significance (p=0.1)). The median duration of dosing was 7.5 days for rt-PA and 12 days for placebo. There was a significant beneficial effect of rt-PA on rate of clot resolution Low-dose rt-PA for the treatment of ICH with IVH has an acceptable safety profile compared to placebo and prior historical controls. Data from a well-designed Phase III clinical trial, such as CLEAR III, will be needed to fully evaluate this treatment. Participant enrollment began prior to July 1, 2005.