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STUDY PROTOCOL article
Front. Neurol.
Sec. Stroke
Volume 15 - 2024 |
doi: 10.3389/fneur.2024.1455388
This article is part of the Research Topic Novel approaches in diagnosis and management of ischemic edema in large vessel occlusion stroke - Volume II View all 7 articles
Albumin adjuvant therapy for acute ischemic stroke with large vessel occlusion (AMASS-LVO): Rationale, design, and protocol for a phase 1, open-label, clinical trial
Provisionally accepted- 1 Tianjin Huanhu Hospital, Tianjin, China
- 2 Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, China
- 3 Capital Medical University, Beijing, Beijing Municipality, China
Background: Acute ischemic stroke (AIS) is an acute brain injury caused by sudden occlusion of a blood vessel. Endovascular therapy is the most effective way to restore blood flow.However, despite the restoration of blood flow in some patients, their clinical prognosis often remains unsatisfactory. Albumin has shown neuroprotective effects in animal models of AIS.Therefore, this study aims to evaluate the safety, feasibility, and efficacy of local arterial infusions of 20% human serum albumin solution as an adjuvant therapy after endovascular therapy in patients with AIS.Methods: This study is a prospective, therapeutic exploratory, non-randomized, open-label, phase 1 clinical trial testing the use of 20% human serum albumin solution injected via the artery immediately after successful reperfusion in patients with AIS. The study is divided into two stages. In the first stage, a single-dose-finding will explore the maximum safe dose according to the 3+3 dose escalation principle;, with the maximum dose being 0.60 g/kg. After recanalizing the occluded blood vessel, human serum albumin solution will be injected into the internal carotid artery region through a guiding catheter for 30 min. The second stage involves an albumin adjuvant therapy cohort (AT) and an endovascular treatment lonely cohort (ET).The AT cohort will encompass at least 15 additional participants to complete safety trials at the maximum safe dose determined in the first stage. The ET cohort will include well-matched patients receiving endovascular therapy alone, derived from a contemporaneous prospective registry, who will be excluded from having cardiopulmonary disorders and from receiving any neuroprotective therapy. The primary outcome of this study will be symptomatic intracranial hemorrhage. Efficacy outcomes will include the proportion of patients with the progression of cerebral infarction volume, a modified Rankin Scale of 0-2 on day 90 after randomization. An exploratory secondary outcome will be the analysis of thromboinflammatory and neuroprotective molecule profiles.This pilot trial aims to explore the safety and efficacy of arterial infusion of an albumin solution after occlusive vessel opening in AIS. The results will provide data parameters
Keywords: Acute ischemic stroke, Albumin (ALB), Endovascular therapy (EVT), Clinical Trial, Large vessel occlusion (LVO)
Received: 19 Jul 2024; Accepted: 13 Sep 2024.
Copyright: © 2024 Pan, Du, Liu, Wang, Luo, Xu, Cao, Chen, JI and Wei. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Si h. Pan, Tianjin Huanhu Hospital, Tianjin, China
Si f. Wang, Tianjin Huanhu Hospital, Tianjin, China
Yong b. Xu, Tianjin Huanhu Hospital, Tianjin, China
Jian Chen, Xuanwu Hospital, Capital Medical University, Beijing, 100053, Beijing Municipality, China
Xunming JI, Capital Medical University, Beijing, 100069, Beijing Municipality, China
Ming Wei, Tianjin Huanhu Hospital, Tianjin, China
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