A Phase 1 interventional study of Albumin in Stroke, Acute Ischemic, Albumin and Endovascular Procedures, sponsored by Tianjin Huanhu Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Tianjin Huanhu Hospital · Phase 1, Interventional, and Treatment
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.
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 57 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Tianjin Huanhu Hospital is the lead sponsor of 25 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
All cause of death
all cause of death within 90 days
Time frame: 90 days after initiation of infusion of albumin intra-arterially.
symptomatic intracranial hemorrhage
symptomatic intracranial hemorrhage within 24 (±6) hours
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially
rate of serious adverse events
rate of serious adverse events within 90 (±14) days
Time frame: 90 (±14) days after initiation of infusion of albumin intra-arterially
all intracranial hemorrhages
all intracranial hemorrhages within 24 (±6) hours
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially
pneumonia
pneumonia within 24 hours after infusion
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially
adverse events related to albumin infusion
adverse events related to albumin infusion within 24 hours after infusion
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially
Imaging Biomarker
image biomarker outcomes include Infarct volume at 24 (±6) hours
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially
Imaging Biomarker
Infarct volume growth from baseline at 24 (±6) hours
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially
early neurological biomarkers
NIHSS scores at 24 (±6) hours
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially;
early neurological biomarkers
NIHSS scores at 7 (±1) days or at hospital discharge
Time frame: 7 (±1) days or at hospital discharge after initiation of infusion of albumin intra-arterially
long-term neurological biomarkers
Neurologic outcomes include proportion of mRS scores 0-2 at 90 (±14) hours
Time frame: 90 (±14) days after initiation of infusion of albumin intra-arterially
long-term neurological biomarkers
distribution of mRS scores at 90 (±14) days
Time frame: 90 (±14) days after initiation of infusion of albumin intra-arterially
peripheral immune responses
immune cell counts (neutrophil , white blood cell , lymphocyte , monocyte , platelet ) at 24 hours.
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially.
peripheral immune responses
inflammatory markers(neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) )at 24 hours.
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially.
circulating molecular
Proteome and Metabolome analysis
Time frame: 24 (±6) hours after initiation of infusion of albumin intra-arterially.
Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Tianjin Huanhu Hospital