重组凝血因子VIIa：缩短重度创伤性脑损伤凝血障碍患者的干预时间。

Recombinant factor VIIa: decreasing time to intervention in coagulopathic patients with severe traumatic brain injury.

作者信息

Stein Deborah M, Dutton Richard P, Kramer Mary E, Handley Christopher, Scalea Thomas M

机构信息

R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, USA.

出版信息

J Trauma. 2008 Mar;64(3):620-7; discussion 627-8. doi: 10.1097/TA.0b013e3181650fc7.

DOI:10.1097/TA.0b013e3181650fc7

PMID:18332801

Abstract

BACKGROUND

Treatment of coagulopathy is often needed before neurosurgical intervention in patients with traumatic brain injury (TBI). Typically, this is accomplished with administration of plasma. We hypothesized that the off-label use of recombinant factor VIIa (rFVIIa) to normalize the coagulation profile would allow for earlier intervention than conventional therapy.

METHODS

The trauma registry was used to identify patients with severe TBI who were admitted during a 4-year period and were coagulopathic at admission (international normalized ratio, INR >/=1.4) and required a neurosurgical procedure. Severe TBI was defined as head abbreviated injury scale (AIS) >3 and admission Glasgow coma score (GCS) <9. Demographics, injury, blood bank and laboratory data, time of intervention, rFVIIa use, and complications were abstracted. Characteristics of the group who received rFVIIa were compared against those treated with plasma alone with a Student's t test and chi analysis, as well as nonparametric methods for comparison of medians.

RESULTS

Of 681 patients with severe TBI, 63 were coagulopathic at admission and needed an emergent neurosurgical procedure. Twenty-nine patients who received rFVIIa were compared against 34 patients who were treated with only plasma. Mean age, injury severity score (ISS), and admission GCS and INR were not different between the two groups. Time to neurosurgical intervention was less in the rFVIIa group (median = 144 vs. 446 minutes, p = 0.0003) as were the number of units of plasma administered before intervention (median = 2 vs. 6, p = 0.0006). The rate of thromboembolic complications was not different between groups. In patients with isolated TBI, mortality was 33.3% in the rFVIIa group and 52.9% in controls (p = 0.24).

CONCLUSION

rFVIIa rapidly and effectively reversed coagulopathy in patients with severe TBI. rFVIIa decreased the time to intervention and decreased the use of blood products without increasing the rate of thromboembolic complications.

摘要

背景

创伤性脑损伤（TBI）患者在进行神经外科干预之前通常需要治疗凝血功能障碍。通常，这是通过输注血浆来完成的。我们假设，使用重组凝血因子VIIa（rFVIIa）进行非标签治疗以使凝血指标正常化，将比传统疗法更早地进行干预。

方法

利用创伤登记系统确定在4年期间入院且入院时存在凝血功能障碍（国际标准化比值，INR≥1.4）并需要进行神经外科手术的重度TBI患者。重度TBI定义为头部简明损伤定级标准（AIS）>3且入院时格拉斯哥昏迷评分（GCS）<9。提取人口统计学、损伤情况、血库和实验室数据、干预时间、rFVIIa使用情况及并发症。将接受rFVIIa治疗的患者组的特征与仅接受血浆治疗的患者组进行比较，采用学生t检验和卡方分析以及中位数比较的非参数方法。

结果

在681例重度TBI患者中，63例入院时存在凝血功能障碍且需要紧急神经外科手术。将29例接受rFVIIa治疗的患者与34例仅接受血浆治疗的患者进行比较。两组患者的平均年龄、损伤严重程度评分（ISS）、入院时GCS和INR无差异。rFVIIa组至神经外科干预的时间较短（中位数=144分钟对446分钟，p=0.0003），干预前输注血浆的单位数量也较少（中位数=2对6，p=0.0006）。两组间血栓栓塞并发症发生率无差异。在单纯TBI患者中，rFVIIa组死亡率为33.3%，对照组为52.9%（p=0.24）。