Kangjie Du, Shuling Liu, Thanh N Nguyen, Sihu Pan, Jean-Claude Baron, Yongbo Xu, Mohamad Abdalkader, Leilei Luo, Sifei Wang, Jian Chen, Yuchao Dou, Shuai Liu, Xunming Ji, Ming Wei
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引用次数: 0
Abstract
Background: Despite successful mechanical thrombectomy (MT), approximately 50% of patients with large vessel occlusion (LVO) stroke experience poor outcomes due to reperfusion injury. Intra-arterial infusion of human serum albumin (HSA) may offer neuroprotective benefits; however, its safety and feasibility have not been established when delivered via the internal carotid artery. In this study we aimed to evaluate the safety and technical feasibility of HSA infusion through the guiding catheter placed during MT in patients with anterior circulation LVO stroke following successful reperfusion.
Methods: We conducted a prospective, single-center, open-label, pilot trial evaluating intra-arterial infusion of 20% HSA immediately after MT in patients with anterior circulation LVO stroke. The study included a 3+3 dose-escalation and a dose-expansion phase. Eligible patients achieved successful reperfusion (modified Thrombolysis in Cerebral Infarction score ≥2b) and received HSA infusion via the guiding catheter. Safety endpoints included 90-day mortality, symptomatic intracranial hemorrhage (sICH), and serious adverse events. Post-hoc analyses explored infarct volume, immune markers, and proteomic/metabolomic signatures.
Results: Between September 2023 and February 2024, 42 patients received intra-arterial HSA infusion. In the dose-escalation phase (n=27), two deaths and two mild infusion-related adverse events occurred, with no sICH. In the dose-expansion phase (n=15), one death and one case of sICH were reported, with no HSA-related adverse events. Post-hoc analysis showed that the HSA group had a significantly smaller infarct volume at 24 hours compared with controls.
Conclusions: Intra-arterial infusion of 20% HSA in combination with MT is safe and feasible. Preliminary findings suggest a potential therapeutic benefit in reducing infarct volume.
期刊介绍：
The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal launch follows growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal compression.The journal is owned by SNIS and is also the official journal of the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), the Canadian Interventional Neuro Group, the Hong Kong Neurological Society (HKNS) and the Neuroradiological Society of Taiwan.
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