Hemostatic efficacy of a fibrin sealant-based topical agent in a femoral artery injury model: A randomized, blinded, placebo-controlled study
Hemostatic efficacy of a fibrin sealant-based topical agent in a femoral artery injury model: A randomized, blinded, placebo-controlled study
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DOI：
10.1016/s0741-5214(97)70189-7
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发表时间：
1997-08-01
影响因子：
4.3
通讯作者：
Alving, BM
中科院分区：
文献类型：
--
作者：
Jackson, MR;Friedman, SA;Alving, BM
目的：目前可用的局部止血剂的有效性需要从循环血液中形成纤维蛋白。由高浓度凝血酶和纤维蛋白原制备的纤维蛋白原密封剂已以液体形式用于血管手术期间促进止血。在一个盲目的，随机的，安慰剂对照的方式，我们评估了干燥敷料的纯化，病毒灭活的人纤维蛋白原和人凝血酶在一个大的动物模型动脉injury.Methods：敷料制备的应用层冻干的人纤维蛋白密封剂或免疫球蛋白G（IgG，对照）的硅胶背衬材料。6只麻醉的雌性约克郡猪（16 - 27 kg）在手术暴露动脉后接受双侧4 mm纵向股动脉切开术。动脉切开术未闭合。在每只动物中，将纤维蛋白封闭剂敷料应用于一条动脉，将对照敷料应用于另一条动脉。通过机械装置将每个敷料固定在动脉切开处，应用敷料后，恢复每个肢体的血流1小时。每隔15分钟释放压缩器械5秒，以评估止血情况。结果：与对照敷料相比，用纤维蛋白敷料治疗的动脉切开术的失血量（平均值+/- SEM）显著减少（4.9 +/- 4.0 ml vs 82.3 +/- 11.1 ml; p = 0.0005）。在1小时的评估期间，6例接受纤维蛋白封闭剂治疗的动脉切开术中有5例在前15分钟间隔内实现完全止血，6例对照动脉切开术中无1例实现完全止血（p = 0.03）。治疗组和对照组动脉基线时通过每条股动脉的血流量相同（纤维蛋白封闭剂，114.2 +/- 17.4 ml/min;对照组，106.7 +/- 16.5 ml/min; p = 0.24），在整个实验过程中无显著差异。这些敷料的进一步开发将解决临床使用的最佳配方和配置。我们的研究结果表明，纤维蛋白基敷料可有效促进动脉出血的止血，而不会影响血流。
Purpose: The efficacy of currently available topical hemostatic agents requires the formation of fibrin generated from circulating blood. Fibrin sealant, which is prepared from high concentrations of thrombin and fibrinogen, has been used in liquid form to promote hemostasis during vascular surgery. In a blinded, randomized, placebo-controlled fashion, we evaluated a dry dressing of purified, viral-inactivated human fibrinogen and human thrombin in a large animal model of arterial injury.Methods: Dressings were prepared by application of a layer of lyophilized human fibrin sealant or immunoglobulin G (IgG, control) to a silicone backing material. Six anesthetized female Yorkshire pigs (16 to 27 kg) received bilateral, 4 mm longitudinal femoral arteriotomies after surgical exposure of the arteries. The arteriotomies were not closed. In each animal a fibrin sealant dressing was applied to one artery and a control dressing to the other. Each dressing was secured on the arteriotomy by a mechanical device, After application of the dressings, blood flow was restored to each limb for 1 hour. The compressive device was released for 5 seconds at intervals of 15 minutes to assess hemostasis. Blood flow was measured distal to each arteriotomy with a dual-channel flowmeter to adjust equal bilateral compression.Results: Blood loss (mean +/- SEM) was significantly less from the arteriotomy treated with the fibrin-based dressing compared with the control dressing (4.9 +/- 4.0 mi versus 82.3 +/- 11.1 ml; p = 0.0005). Complete hemostasis was achieved at the first 15-minute interval in five of six arteriotomies treated with fibrin sealant and in none of the six control arteriotomies during 1 hour of assessment (p = 0.03). Blood flow through each femoral artery at baseline was the same in both treatment and control arteries (fibrin sealant, 114.2 +/- 17.4 ml/min; control, 106.7 +/- 16.5 ml/min; p = 0.24) and was not significantly different throughout the experiment.Conclusions: Fibrin-based dressings provide effective hemostasis in a large animal model of arterial injury. Further development of these dressings will address optimal formulation and configuration for clinical use. Our results suggest that fibrin-based dressings will be effective in promotion of hemostasis in arterial bleeding, without compromising blood flow.