NCT05953623

Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

A Phase Ib Dose-Escalation Study of Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Tianjin Huanhu Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Albumin, the predominant plasma protein synthesized primarily in the liver, possesses various biochemical properties that are expected to confer a neuroprotective effect following acute ischemic stroke. Despite being utilized as a neuroprotective agent for stroke patients, albumin has not demonstrated efficacy, partly due to the persistence of the occluded vessel responsible for the stroke, thereby hindering the albumin's ability to exert its therapeutic effects in the ischemic region. In light of the advent of thrombectomy and subsequent recanalization of occluded blood vessels, it is imperative to reassess the potential impact of albumin. In first phase of this study, we plan to conduct a 3 + 3 dose-escalation trial to determine the safety and feasibility of intra-arterial albumin infusion for stroke patients undergoing successful mechanical thrombectomy. Since this is a 3 + 3 dose-escalation study with 7 doses (0.25g/kg, 0.35g/kg, 0.40g/kg, 0.45g/kg, 0.5g/kg, 0.55g/kg,0.60g/kg), a minimum of 21 (7 groups × 3 patient/group) patients will be required, assuming no major response occurs at any dose level, and a maximum of 42 (7 groups × 6 patient/group) patients will be required, assuming one major response occurs at each dose level. In second phase, at the maximum safe dose determined in the first phase, an additional 15 to 20 patients will be enrolled for intra-arterial albumin infusion.

Conditions

• Stroke, Acute Ischemic
• Albumin
• Endovascular Procedures
• Large Vessel Occlusion

Interventions

Type	Name	Description
BIOLOGICAL	Albumin	In the first phase of the study, a 3 + 3 dose-escalation study with 7 doses (0.25g/kg, 0.35g/kg, 0.40g/kg, 0.45g/kg, 0.5g/kg, 0.55g/kg, 0.60g/kg). Intra-arterial albumin infusion will be applied after successful recanalization of the culprit artery in the anterior circulation. In the second phase of the study, at the maximum safe dose determined in the first phase, an additional 15 to 20 patients will be enrolled for intra-arterial albumin infusion.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-06-29
• Completion: 2024-10-01
• First posted: 2023-07-20
• Last updated: 2025-07-22

Locations

1 site across 1 country: China