Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

NCT05953623 | Completed Phase 1 DMC

• 1 other identifier: TJHH-2023-WeiMing617
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Acute Ischemic Stroke; Albumin; Endovascular Therapy; Large Vessel Occlusion

Outcome Measures

Primary Outcomes (1)

• All cause of death

  all cause of death within 90 days

  90 days after initiation of infusion of albumin intra-arterially.

Secondary Outcomes (5)

• symptomatic intracranial hemorrhage

  24 (±6) hours after initiation of infusion of albumin intra-arterially

• rate of serious adverse events

  90 (±14) days after initiation of infusion of albumin intra-arterially

• all intracranial hemorrhages

  24 (±6) hours after initiation of infusion of albumin intra-arterially

• pneumonia

  24 (±6) hours after initiation of infusion of albumin intra-arterially

• adverse events related to albumin infusion

  24 (±6) hours after initiation of infusion of albumin intra-arterially

Other Outcomes (9)

• Imaging Biomarker

  24 (±6) hours after initiation of infusion of albumin intra-arterially

• Imaging Biomarker

  24 (±6) hours after initiation of infusion of albumin intra-arterially

• early neurological biomarkers

  24 (±6) hours after initiation of infusion of albumin intra-arterially;

Study Arms (1)

Intra-arterial albumin infusion

EXPERIMENTAL

Biological: Albumin

Interventions

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.

Intra-arterial albumin infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years;
• Patients with acute ischemic stroke caused by large vessel occlusion in the intracranial anterior circulation (internal carotid artery, middle cerebral artery M1 and M2 segments) ;
• mTICI score ≥ 2b for the occlude vessel after mechanical thrombectomy;
• Baseline National Institutes of Health Stroke score (NIHSS) ≥ 6;
• Stroke onset to arterial puncture time within 24 hours.

You may not qualify if:

• Upon admission, the patient's medical history and physical examination revealed manifestations indicative of congestive heart failure (CHF), such as jugular venous distention, the presence of a third heart sound, resting tachycardia at a rate of 100 beats per minute attributable to heart failure, hepatomegaly, and/or lower extremity edema attributable to heart failure or of unknown etiology;
• History of acute myocardial infarction within the preceding 3 months;
• The patient's medical history, electrocardiogram findings upon admission, or physical examination indicated the presence of second- or third-degree heart block or any arrhythmia associated with hemodynamic instability, as determined by the investigator's assessment;
• Acute or chronic renal failure with serum creatinine levels exceeding 2.0 mg/dL;
• Severe anemia characterized by a hematocrit below 32%;
• Computed tomography findings upon admission indicating the presence of any form of hemorrhage;
• Pregnancy status;
• Previous history of allergic reactions to albumin administration;
• Elevated blood pressure exceeding 185/110 mmHg when investigating the use of albumin administration;
• Presence of other potentially life-threatening medical conditions;
• Individuals with current chronic lung diseases, such as chronic obstructive pulmonary disease, bronchiectasis, or any other lung disorder that significantly impairs daily activities; 12. Individuals with known allergies to albumin.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300222, China

Location

Related Publications (2)

• 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.

  PMID: 40921621 DERIVED

• 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.

  PMID: 39403266 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Albumins

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: August 1, 2023
• Primary Completion: June 29, 2024
• Study Completion: October 1, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)