Royal Infirmary of Edinburgh, Edinburgh, UK.
Br J Surg. 2010 Dec;97(12):1784-9. doi: 10.1002/bjs.7235. Epub 2010 Aug 20.
This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL(™) Fibrin Sealant (Human)) during vascular surgery.
This prospective randomized controlled trial compared the haemostatic effectiveness of fibrin sealant (75 patients) or manual compression (72) in polytetrafluoroethylene (PTFE) arterial anastomoses. The primary endpoint was the absence of bleeding at the anastomosis at 4 min after randomization. Secondary endpoints included haemostasis at 7 and 10 min, treatment failures and the incidence of complications potentially related to bleeding. Adverse events were recorded.
A higher percentage of patients who received fibrin sealant versus manual compression achieved haemostasis at 4 min (85 versus 39 per cent respectively; odds ratio 11·34, 95 per cent confidence interval 4·67 to 27·52; P < 0·001). Similarly, a higher percentage of patients who received fibrin sealant achieved haemostasis at 7 and 10 min (both P < 0·001). The incidence of treatment failure was lower in the fibrin sealant group (P < 0·001). The rate of complications potentially related to bleeding was similar (P = 0·426). Some 64 per cent of patients who received fibrin sealant experienced at least one adverse event, compared with 71 per cent who received manual compression.
This fibrin sealant was safe, and significantly shortened the time to haemostasis in vascular procedures using PTFE.
NCT00154141 (http://www.clinicaltrials.gov).
本研究评估了一种纤维蛋白粘合剂（EVICEL(™) 纤维蛋白粘合剂（人））在血管外科手术中的安全性和止血效果。
这是一项前瞻性随机对照试验，比较了纤维蛋白粘合剂（75 例）或手动压迫（72 例）在聚四氟乙烯（PTFE）动脉吻合术中的止血效果。主要终点是随机分组后 4 分钟吻合口无出血。次要终点包括 7 分钟和 10 分钟时的止血情况、治疗失败和可能与出血相关的并发症发生率。记录不良事件。
与手动压迫相比，接受纤维蛋白粘合剂治疗的患者在 4 分钟时达到止血的比例更高（分别为 85%和 39%；优势比 11.34，95%置信区间 4.67 至 27.52；P<0.001）。同样，接受纤维蛋白粘合剂治疗的患者在 7 分钟和 10 分钟时达到止血的比例更高（均 P<0.001）。纤维蛋白粘合剂组治疗失败的发生率较低（P<0.001）。与出血相关的并发症发生率相似（P=0.426）。与接受手动压迫的患者相比，接受纤维蛋白粘合剂治疗的患者中有 64%至少出现了一次不良事件，而接受手动压迫的患者中有 71%出现了一次不良事件。
这种纤维蛋白粘合剂是安全的，可显著缩短使用 PTFE 的血管手术的止血时间。
NCT00154141（http://www.clinicaltrials.gov）。
