Vidal E, Sharathkumar A, Glover J, Faustino E V S
Department of Structural and Cellular Biology, Tulane University School of Medicine, New Orleans, LA, USA.
J Thromb Haemost. 2014 Jul;12(7):1096-109. doi: 10.1111/jth.12598. Epub 2014 Jun 19.
In preparation for a pediatric randomized controlled trial on thromboprophylaxis, we determined the frequency of catheter-related thrombosis in children. We also systematically reviewed the pediatric trials on thromboprophylaxis to evaluate its efficacy and to identify possible pitfalls in the conduct of these trials.
PATIENTS/METHODS: We searched MEDLINE, EMBASE, Web of Science and the Cochrane Central Register for Controlled Trials for articles published until December 2013. We included cohort studies and trials on patients aged 0-18 years with central venous catheters who underwent active surveillance for thrombosis with radiologic imaging. We estimated the pooled frequency of thrombosis and the pooled risk ratio (RR) with thromboprophylaxis by using a random effects model.
From 2651 articles identified, we analyzed 37 articles with 3128 patients. The pooled frequency of thrombosis was 0.20 (95% confidence interval [CI] 0.16-0.24). In 10 trials, we did not find evidence that heparin-bonded catheters (RR 0.34; 95%CI 0.01-7.68), unfractionated heparin (RR 0.93; 95% CI 0.57-1.51), low molecular weight heparin (RR 1.13; 95% CI 0.51-2.50), warfarin (RR 0.85; 95%CI 0.34-2.17), antithrombin concentrate (RR 0.76; 95% CI 0.38-1.55) or nitroglycerin (RR 1.53; 95%CI 0.57-4.10) reduced the risk of thrombosis. Most of the trials were either not powered for thrombosis or were powered to detect large, probably unachievable, reductions in thrombosis. Missing data on thrombosis also limited these trials.
Catheter-related thrombosis is common in children. An adequately powered multicenter trial that can detect a modest, clinically significant reduction in thrombosis is critically needed. Missing outcome data should be minimized in this trial.
为一项关于儿童血栓预防的随机对照试验做准备，我们确定了儿童导管相关血栓形成的发生率。我们还系统回顾了关于儿童血栓预防的试验，以评估其疗效，并找出这些试验实施过程中可能存在的问题。
患者/方法：我们检索了MEDLINE、EMBASE、科学网和Cochrane对照试验中心注册库，查找截至2013年12月发表的文章。我们纳入了对0至18岁接受中心静脉导管置入且通过影像学进行血栓主动监测的患者的队列研究和试验。我们使用随机效应模型估计血栓形成的合并发生率以及血栓预防的合并风险比（RR）。
从识别出的2651篇文章中，我们分析了37篇涉及3128例患者的文章。血栓形成的合并发生率为0.20（95%置信区间[CI]0.16 - 0.24）。在10项试验中，我们未发现证据表明肝素涂层导管（RR 0.34；95%CI 0.01 - 7.68）、普通肝素（RR 0.93；95%CI 0.57 - 1.51）、低分子量肝素（RR 1.13；95%CI 0.51 - 2.50）、华法林（RR 0.85；95%CI 0.34 - 2.17）、抗凝血酶浓缩剂（RR 0.76；95%CI 0.38 - 1.55）或硝酸甘油（RR 1.53；95%CI 0.57 - 4.10）能降低血栓形成风险。大多数试验要么没有足够的能力检测血栓形成情况，要么有能力检测到血栓形成的大幅降低，但这可能难以实现。关于血栓形成的缺失数据也限制了这些试验。
导管相关血栓形成在儿童中很常见。迫切需要一项有足够效力的多中心试验，该试验能够检测到血栓形成有适度的、具有临床意义的降低。在该试验中应尽量减少结局数据的缺失。
