Bartal Carmi, Freedman John, Bowman Kim, Cusimano Michael
Medical-Surgical Intensive Care Unit, Department of Critical Care, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
J Trauma. 2007 Oct;63(4):725-32. doi: 10.1097/TA.0b013e318031ccca.
The combination of coagulopathy and intracranial bleeding (ICB) is a well-recognized cause of morbidity and mortality in the neurosurgical patient because of the risk of hematoma expansion. Although recombinant factor VIIa (rFVIIa) has been shown to be useful in intracerebral hemorrhage, its use in other forms of ICB such as subdural hematomas (SDHs) has rarely been described.
The clinical and laboratory features of a prospectively followed up case-series of 15 patients with traumatic ICB (mainly isolated SDHs) and coagulopathy international normalized ratio (INR) >1.3 treated with rFVIIa in our institution are presented, along with a review of the literature regarding the role of rFVIIa in neurosurgical patients with ICB.
All 15 patients suffered a SDH (4 of 15 had a combined ICB) and coagulopathy (mean INR, 2.34 +/- 0.83; thrombocytopenia rate, 20%), which was attributed to anticoagulants in 46.7%. The mean INR decreased to 1.5 +/- 0.14 after standard therapy and 0.92 +/- 0.1 after rFVIIa therapy. There was no evident progression of bleeding in any patient treated with rFVIIa. In three patients, neurosurgery was obviated by rFVIIa therapy, whereas the other 12 patients underwent neurosurgery safely and successfully. None required subsequent surgery for continuing hemorrhage, and no adverse events secondary to FVIIa administration were observed. Based on our experience and the reviewed literature, a proposed algorithm for a stratified approach to rFVIIa administration in traumatic ICB is discussed.
rFVIIa is an inducer of hemostasis, which successfully controlled potentially devastating bleeding in all of 15 coagulopathic neurosurgical patients with ICB. The use of rFVIIa lowered the INR into the operable range in all patients, allowing surgery, and in some cases, obviated the need for surgery. Randomized, placebo-controlled clinical trials are needed to further assess the efficacy and cost-effectiveness of this approach in this setting.
由于存在血肿扩大的风险，凝血功能障碍与颅内出血（ICB）并存是神经外科患者发病和死亡的一个公认原因。尽管重组凝血因子VIIa（rFVIIa）已被证明对脑出血有效，但其在其他形式的ICB（如硬膜下血肿（SDH））中的应用却鲜有报道。
本文介绍了在我们机构前瞻性随访的15例创伤性ICB（主要为孤立性SDH）且凝血国际标准化比值（INR）>1.3并接受rFVIIa治疗患者的临床和实验室特征，并回顾了关于rFVIIa在患有ICB的神经外科患者中作用的文献。
所有15例患者均患有SDH（15例中有4例合并ICB）和凝血功能障碍（平均INR为2.34±0.83；血小板减少率为20%），其中46.7%的患者凝血功能障碍归因于抗凝剂。标准治疗后平均INR降至1.5±0.14，rFVIIa治疗后降至0.92±0.1。接受rFVIIa治疗的任何患者均未出现明显的出血进展。3例患者通过rFVIIa治疗避免了神经外科手术，而其他12例患者安全、成功地接受了神经外科手术。无一例患者因持续出血需要后续手术，也未观察到FVIIa给药引起的不良事件。基于我们的经验和文献回顾，讨论了一种针对创伤性ICB中rFVIIa给药的分层方法的建议算法。
rFVIIa是一种止血诱导剂，成功控制了15例患有ICB的凝血功能障碍神经外科患者中潜在的毁灭性出血。rFVIIa的使用使所有患者的INR降至可手术范围，从而得以进行手术，在某些情况下，还避免了手术的需要。需要进行随机、安慰剂对照临床试验，以进一步评估这种方法在此情况下的疗效和成本效益。
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