NCT06172387

Intra-arterial Albumin in Acute Ischemic Stroke After Endovascular Treatment for

The Efficacy of Intra-arterial Albumin With Endovascular Treatment for Acute Ischemic Stroke : A Randomized, Controlled Pilot Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Tianjin Huanhu Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Stroke is an acute focal injury of the central nervous system caused by cerebral vessels. One in every four people is affected by stroke at different times in life. Globally, stroke is the second leading cause of death and third leading cause of disability in adults. we hypothesized that in patients with acute large vessel occlusive ischemic stroke treated with mechanical thrombectomy, the infusion of 20% human serum albumin solution into the revascularization area can exert a stronger neuroprotective effect.

Detailed description

In the previous period, we have conducted a clinical trial on the safety and feasibility of arterial infusion of 20% human serum albumin solution. The results of the study found that after arterial infusion of 20% human serum albumin solution at a dose of 0.6g/kg to the subject's vascularization area, the subjects did not develop significant complications related to albumin solution. There were no serious adverse events associated with arterial infusion of albumin solution in all subjects. After the evaluation of the Data Safety Monitoring Board, the clinical study was considered to be the next step, which is to initially explore the effectiveness of 0.6g/kg arterial infusion of 20% human serum albumin solution for neuroprotection of subjects.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	intra-arterial infusion albumin	The experimental group would inject 20% human blood albumin solution into the responsible blood vessel supply area by catheter artery at a dose of 0.6g/kg. The infusion time is 20-30 minutes. All participant will receive mechanical thrombectomy and a standard clinical therapy.
OTHER	mechanical thrombectomy and a standard clinical therapy	mechanical thrombectomy and a standard clinical therapy

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-12-15
• Last updated: 2023-12-15

Locations

1 site across 1 country: China