Intraventricular thrombolysis speeds blood clot resolution: Results of a pilot, prospective, randomized, double-blind, controlled trial
Intraventricular thrombolysis speeds blood clot resolution: Results of a pilot, prospective, randomized, double-blind, controlled trial
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DOI：
10.1227/01.neu.0000108422.10842.60
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发表时间：
2004-03-01
期刊：
影响因子：
4.8
通讯作者：
Schmutzhard, E
中科院分区：
文献类型：
--
作者：
Naff, NJ;Hanley, DF;Schmutzhard, E
目的：动物模型和临床研究表明，脑室内溶栓可改善脑室内出血患者的血栓溶解和临床结局。然而，这种干预可能会增加再出血和感染的发生率。为了评估脑室内溶栓的安全性和有效性，我们进行了一项先导性、随机、双盲、对照、多中心研究。方法：需要脑室造口术的脑室内出血患者随机接受生理盐水或尿激酶（25,000国际单位）的脑室内注射，间隔12小时。根据预先规定的临床标准，持续注射直至脑室引流停止。每天进行头部计算机断层扫描，以定量测定脑室内出血量。估计各组的血栓消退率。结果：12例受试者入组（尿激酶，7例患者;安慰剂，5例患者）。尿激酶的商业停药排除了额外入组。尿激酶组和安慰剂组在年龄（49.6岁vs 55.2岁，P = 0.43）和格拉斯哥昏迷量表评分（7.14 vs 8.00，P = 0.72）方面相似。随机分配至尿激酶治疗组（P = 0.02）和女性（P = 0.008）有利地影响了血凝块消退率。尿激酶治疗组的性别调整后的血凝块半衰期减少了44.6%，与安慰剂组的值相比（4.69与8.48天）。结论：与单独脑室引流治疗相比，尿激酶脑室内溶栓加速了脑室内血凝块的消退。
OBJECTIVE: Animal models and clinical studies suggest that intraventricular thrombolysis improves clot resolution and clinical outcomes among patients with intraventricular hemorrhage. However, this intervention may increase the rates of rebleeding and infection. To assess the safety and efficacy of intraventricular thrombolysis, we conducted a pilot, randomized, double-blind, controlled, multicenter study.METHODS: Patients with intraventricular hemorrhage requiring ventriculostomy were randomized to receive intraventricular injections of normal saline solution or urokinase (25,000 international units) at 12-hour intervals. Injections continued until ventricular drainage was discontinued according to prespecified clinical criteria. Head computed tomographic scans were obtained daily, for quantitative determinations of intraventricular hemorrhage volumes. The rate of clot resolution was estimated for each group.RESULTS: Twelve subjects were enrolled (urokinase, seven patients; placebo, five patients). Commercial withdrawal of urokinase precluded additional enrollment. The urokinase and placebo groups were similar with respect to age (49.6 versus 55.2 yr, P = 0.43) and presenting Glasgow Coma Scale scores (7.14 versus 8.00, P = 0.72). Randomization to the urokinase treatment arm (P = 0.02) and female sex (P = 0.008) favorably affected the clot resolution rate. The sex-adjusted clot half-life for the urokinase-treated group was reduced 44.6%, compared with the value for the placebo group (4.69 versus 8.48 d).CONCLUSION: Intraventricular thrombolysis with urokinase speeds the resolution of intraventricular blood clots, compared with treatment with ventricular drainage alone.