drugset / Trial / NCT05953623

Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

NCT05953623

Phase 1 Completed 57 enrolled Tianjin Huanhu Hospital
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

Drugs

EvaluationDrugModalityDoseRoute
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