drugset / Trial / NCT05953623
Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to investigate the safety and feasibility of intra-arterial albumin infusion for patients with acute ischemic stroke after successful thrombectomy and to further explore the optimal dose of albumin through the implementation of a 3 + 3 dose-escalation design. At the maximum safe dose determined in the 3+3 dose-escalation phase, an additional 15 to 20 patients will be enrolled in the study, and comparisons were made with external patients who received endovascular treatment alone.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2024-06-29
- Completion
- 2024-10-01
Publications
- Du K, Liu S, Nguyen TN, Pan S, Baron JC, Xu Y, Abdalkader M, Luo L, Wang S, Chen J, Dou Y, Liu S, Ji X, Wei M. Intra-arterial human serum albumin therapy following mechanical thrombectomy for acute ischemic stroke: the AMASS pilot trial. J Neurointerv Surg. 2025 Sep 8:jnis-2025-023998. doi: 10.1136/jnis-2025-023998. Online ahead of print.
- Pan S, Du K, Liu S, Wang S, Luo L, Xu Y, Cao C, Chen J, Ji X, Wei M. 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. Front Neurol. 2024 Sep 30;15:1455388. doi: 10.3389/fneur.2024.1455388. eCollection 2024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Albumin | Protein / enzyme biologic | 0.25 g/kg | Other |
| Subject | Albumin | Protein / enzyme biologic | 0.35 g/kg | Other |
| Subject | Albumin | Protein / enzyme biologic | 0.4 g/kg | Other |
| Subject | Albumin | Protein / enzyme biologic | 0.45 g/kg | Other |
| Subject | Albumin | Protein / enzyme biologic | 0.5 g/kg | Other |
| Subject | Albumin | Protein / enzyme biologic | 0.55 g/kg | Other |
| Subject | Albumin | Protein / enzyme biologic | 0.6 g/kg | Other |