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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-arterial albumin infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All cause of death | all cause of death within 90 days | 90 days after initiation of infusion of albumin intra-arterially. |
| Measure | Description | Time Frame |
|---|---|---|
| symptomatic intracranial hemorrhage | symptomatic intracranial hemorrhage within 24 (±6) hours | 24 (±6) hours after initiation of infusion of albumin intra-arterially |
| rate of serious adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging Biomarker | image biomarker outcomes include Infarct volume at 24 (±6) hours | 24 (±6) hours after initiation of infusion of albumin intra-arterially |
| Imaging Biomarker | Infarct volume growth from baseline at 24 (±6) hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Huanhu Hospital | Tianjin | Tianjin Municipality | 300222 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40921621 | Derived | 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. | |
| 39403266 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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rate of serious adverse events within 90 (±14) days
| 90 (±14) days after initiation of infusion of albumin intra-arterially |
| all intracranial hemorrhages | all intracranial hemorrhages within 24 (±6) hours | 24 (±6) hours after initiation of infusion of albumin intra-arterially |
| pneumonia | pneumonia within 24 hours after infusion | 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 | 24 (±6) hours after initiation of infusion of albumin intra-arterially |
| 24 (±6) hours after initiation of infusion of albumin intra-arterially |
| early neurological biomarkers | NIHSS scores at 24 (±6) hours | 24 (±6) hours after initiation of infusion of albumin intra-arterially; |
| early neurological biomarkers | NIHSS scores at 7 (±1) days or at hospital discharge | 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 | 90 (±14) days after initiation of infusion of albumin intra-arterially |
| long-term neurological biomarkers | distribution of mRS scores at 90 (±14) days | 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. | 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. | 24 (±6) hours after initiation of infusion of albumin intra-arterially. |
| circulating molecular | Proteome and Metabolome analysis | 24 (±6) hours after initiation of infusion of albumin intra-arterially. |
| 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. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |