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Follow-up Imaging After Thrombolysis: FIAT, A Randomized Trial
Journal of Stroke & Cerebrovascular Diseases ( IF 2.5 ) Pub Date : 2023-04-15 , DOI: 10.1016/j.jstrokecerebrovasdis.2023.107092
Burton Tabaac 1 , Leah Dickstein 2 , Kristen Gurnea 3 , Argye E Hillis 4
Affiliation  

Trial Design

Current protocols for treatment of acute ischemic stroke with intravenous thrombolytics, such as alteplase (tPA) and tenecteplase (tNK), recommend the completion of a routine non-contrast head CT at 24 hours post treatment to evaluate for hemorrhage prior to the initiation of antiplatelet therapy for secondary stroke prevention. This guideline was instituted because it had been part of the protocol in the NINDS multicenter randomized placebo-controlled trial that showed the benefit of IV thrombolytics within 3 hours of stroke onset. Recent observational studies indicate that the repeat (stability) head CT rarely alters clinical management, in the absence of neurological worsening or evidence of clinical signs of hemorrhagic conversion, such as seizures, severe headache, or novel acute deficits. A solitary CT carries with it a non-negligible dose of radiation with additive cost to the medical system at large.

Methods

We aimed to identify, with a randomized, blinded outcome assessment trial, if a routine head CT at 24 hours, in the absence of clinical indication, negatively influences clinical outcomes. We enrolled 58 patients, and evaluated differences between groups with t-tests. We also evaluated differences between outcomes (90 day modified Rankin Scale, mRS and change in National Institutes of Health Stroke Scale, NIHSS) from pretreatment to discharge using multivariable logistic regression, including age, baseline NIHSS, and group as independent variables.

Results

We found no added benefit of routine CT on either outcome measure.

Conclusion

It is likely safe to forgo follow up imaging after thrombolysis in the absence of clinical decompensation.



中文翻译:

溶栓后的随访影像学:FIAT,一项随机试验

试验设计

目前使用阿替普酶 (tPA) 和替奈普酶(tNK) 等静脉溶栓治疗急性缺血性中风的方案建议在治疗后 24 小时完成常规非对比头部 CT,以在开始抗血小板治疗前评估出血情况卒中二级预防的治疗。制定该指南是因为它是 NINDS 多中心随机安慰剂对照试验方案的一部分,该试验显示卒中发作 3 小时内静脉溶栓治疗的益处。最近的观察性研究表明,在没有神经功能恶化或出血性转化临床体征(如癫痫发作、严重头痛或新的急性功能障碍)的证据的情况下,重复(稳定性)头部 CT 很少改变临床管理。单独的 CT 会带来不可忽略的辐射剂量,并且会增加整个医疗系统的成本。

方法

我们的目的是通过一项随机、盲法的结果评估试验来确定,在没有临床指征的情况下,24 小时的常规头部 CT 是否会对临床结果产生负面影响。我们招募了 58 名患者,并使用 t 检验评估了各组之间的差异。我们还使用多变量逻辑回归评估了从治疗前到出院的结果(90 天改良 Rankin 量表、mRS 和美国国立卫生研究院卒中量表 NIHSS 的变化)之间的差异,包括年龄、基线 NIHSS 和组作为独立变量。

结果

我们发现常规 CT 对任一结果测量均无额外益处。

结论

在没有临床失代偿的情况下,溶栓后放弃随访成像可能是安全的。

更新日期:2023-04-17
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