Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA.
Pediatr Crit Care Med. 2010 Jul;11(4):489-95. doi: 10.1097/PCC.0b013e3181ce6e29.
To determine whether a continuous infusion of heparin reduces the rate of catheter-related thrombosis in neonates and infants post cardiac surgery. Central venous and intracardiac catheters are used routinely in postoperative pediatric cardiac patients. Catheter-related thrombosis occurs in 8% to 45% of pediatric patients with central venous catheters.
Single-center, randomized, placebo-controlled, double-blinded trial.
Cardiovascular intensive care unit, university-affiliated children's hospital.
Children <1 yr of age recovering from cardiac surgery.
Patients were randomized to receive either continuous heparin at 10 units/kg/hr or placebo. The primary end point was catheter-related thrombosis as assessed by serial ultrasonography.
Study enrollment was discontinued early based on results from an interim futility analysis. Ninety subjects were enrolled and received the study drug (heparin, 53; placebo, 37). The catheter-related thrombosis rate in the heparin group, compared with the placebo group, was 15% vs. 16% (p = .89). Subjects in the heparin group had a higher mean partial thromboplastin time (52 secs vs. 42 secs, p = .001), and this difference was greater for those aged <30 days (64 secs vs. 43 secs, p = .008). Catheters in place > or = 7 days had both a greater risk of thrombus formation (odds ratio, 4.3; p = .02) and catheter malfunction (odds ratio, 11.2; p = .008). We observed no significant differences in other outcome measures or in the frequency of adverse events.
A continuous infusion of heparin at 10 units/kg/hr was safe but did not reduce catheter-related thrombus formation. Heparin at this dose caused an increase in partial thromboplastin time values, which, unexpectedly, was more pronounced in neonates.
确定肝素持续输注是否会降低心脏手术后新生儿和婴儿中心静脉导管相关血栓形成的发生率。中心静脉和心内导管在术后儿科心脏病患者中常规使用。在接受中心静脉导管的儿科患者中，有 8%至 45%发生导管相关血栓形成。
单中心、随机、安慰剂对照、双盲试验。
心血管重症监护病房，大学附属儿童医院。
心脏手术后正在康复的年龄小于 1 岁的儿童。
患者被随机分配接受 10 单位/公斤/小时的肝素或安慰剂。主要终点是通过连续超声评估导管相关血栓形成。
根据中期无效性分析的结果，提前停止了研究招募。共纳入 90 例患者并接受了研究药物（肝素 53 例，安慰剂 37 例）。肝素组与安慰剂组的导管相关血栓形成率分别为 15%和 16%（p =.89）。肝素组的平均部分凝血活酶时间较高（52 秒与 42 秒，p =.001），年龄小于 30 天的患者差异更大（64 秒与 43 秒，p =.008）。放置时间≥7 天的导管血栓形成风险更高（比值比 4.3；p =.02），导管功能障碍的风险也更高（比值比 11.2；p =.008）。我们没有观察到其他结局指标或不良事件的频率有显著差异。
以 10 单位/公斤/小时的剂量持续输注肝素是安全的，但不能降低导管相关血栓形成的发生率。该剂量的肝素导致部分凝血活酶时间值增加，出乎意料的是，在新生儿中更为明显。
