Introduction: Intracerebral hemhaemorrhage (ICH) is the deadliest form of stroke. HemHaematoma expansion (HE), growth of the hemhaematoma between the baseline computed tomography (CT) scan and a follow-up CT scan at 24±6 hours, predicts long-term disability or death. Recombinant Factor VIIa (rFVIIa) has reduced HE in previous clinical trials with a variable effect on clinical outcomes, with the greatest impact on HE and potential benefit when administered within two hours of symptom onset.

Methods: Factor VIIa for HemHaemorrhagic Stroke Treatment at Earliest Possible Time (FASTEST, NCT03496883) is a randomized controlled trial that will enroll 860 patients at ~100 emergency departments and mobile stroke units in five countries. Patients are eligible for enrollment if they have acute ICH within two hours of symptom onset confirmed by CT, a hemhaematoma volume of 2 to 60 mL, no or small volumes of intraventricular hemhaemorrhage, do not take anticoagulant medications or concurrent heparin/heparinoids (antiplatelet medications are permissible), and are not deeply comatose. Enrolled patients will receive rFVIIa 80 mcg/kg or placebo intravenously over 2 minutes. The primary outcome measure is the distribution of the ordinal modified Rankin Scale at 180 days. FASTEST is monitored by a Data Safety Monitoring Board. Safety endpoints include thrombotic events (e.g., myocardial infarction). Human subjects research is monitored by an external Institutional Review Board in participating countries.

Discussion: In the US, FASTEST will be first NIH StrokeNet Trial with an Exception from Informed Consent which allows enrollment of non-communicative patients without an immediately identifiable proxy.

简介：脑出血（ICH）是最致命的中风形式。血肿扩张 (HE)，即基线计算机断层扫描 (CT) 扫描和 24±6 小时后续 CT 扫描之间血肿的生长，可预测长期残疾或死亡。在之前的临床试验中，重组因子 VIIa (rFVIIa) 已降低 HE，对临床结果产生不同的影响，在症状出现后两小时内给药对 HE 影响最大，并具有潜在益处。

方法：因子 VIIa 尽早治疗出血性中风（FASTEST，NCT03496883）是一项随机对照试验，将在五个国家的约 100 个急诊科和移动中风病房招募 860 名患者。如果患者在症状出现后两小时内经 CT 证实患有急性脑出血，血肿量为 2 至 60 mL，无或少量脑室内出血，未服用抗凝药物或同时服用肝素/类肝素（抗血小板药物），则患者符合入组条件。是允许的），并且没有深度昏迷。入组患者将在 2 分钟内静脉注射 rFVIIa 80 mcg/kg 或安慰剂。主要结果指标是 180 天时序数改良兰金量表的分布。 FASTEST 由数据安全监控委员会监控。安全性终点包括血栓事件（例如心肌梗塞）。人体受试者研究由参与国家的外部机构审查委员会监督。

讨论：在美国，FASTEST 将是第一个 NIH StrokeNet 试验，但有知情同意例外情况，该试验允许在没有立即可识别代理人的情况下招募无法沟通的患者。