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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
Si h. Pan Si h. Pan 1*Kang j. Du Kang j. Du 1Shuling Liu Shuling Liu 1Si f. Wang Si f. Wang 1*Leilei Luo Leilei Luo 1Yong b. Xu Yong b. Xu 1*Chen Cao Chen Cao 1Jian Chen Jian Chen 2*Xunming JI Xunming JI 3*Ming Wei Ming Wei 1*
  • 1 Tianjin Huanhu Hospital, Tianjin, China
  • 2 Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, China
  • 3 Capital Medical University, Beijing, Beijing Municipality, China

The final, formatted version of the article will be published soon.

    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

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.