The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke

NCT07294391 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: TJHH_WM_20251125
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Albumin-assisted therapy has demonstrated good safety and potential neuroprotective effects following mechanical thrombectomy. To further systematically evaluate its efficacy and safety, we are conducting a Phase IIa clinical trial of intra-arterial albumin administration combined with mechanical thrombectomy in patients with acute ischemic stroke. This is a double-center, prospective, open-label, endpoint-blinded, randomized controlled trial designed to preliminarily assess the efficacy and safety of intra-arterial infusion of 20% human albumin after successful recanalization in patients with acute ischemic stroke caused by anterior circulation large-vessel occlusion who undergo mechanical thrombectomy. A total of 60 patients will be enrolled and randomized in a 1:1 ratio by dynamic minimization into two groups: the albumin group (0.6 g/kg of 20% human albumin solution plus mechanical thrombectomy) and the control group (mechanical thrombectomy alone). The primary objective of this study is to preliminarily evaluate whether intra-arterial infusion of 0.6 g/kg of 20% human albumin via the internal carotid artery immediately after achieving successful recanalization (eTICI ≥ 2b) can reduce infarct volume compared with mechanical thrombectomy alone in patients with anterior circulation large-vessel occlusion who undergo standard mechanical thrombectomy. The secondary objective is to assess the safety and feasibility of intra-arterial infusion of 0.6 g/kg of 20% human albumin immediately after successful recanalization in this patient population.

Conditions

Acute Ischemic Stroke From Large Vessel Occlusion

Keywords

Acute ischemic stroke; large vessel occlusion; mechanical thrombectomy; albumin; neuroprotection

Outcome Measures

Primary Outcomes (1)

• Growth in infarct volume at 24 (±6) hours after randomization compared to baseline

  MRI-DWI

  at 24 (±6) hours after randomization

Secondary Outcomes (17)

• Proportion of favorable functional outcome at 90 (±14) days, defined as mRS 0-2

  at 90 (±14) day after randomizatio

• Infarct volume at 24 (±6) hours

  at 24 (±6) hours after randomization

• Proportion of excellent functional at 90 (±14) days, defined as mRS 0-1

  at 90 (±14) day after randomization

• mRS score at 90 (±14) days

  at 90 (±14) days after randomization

• Vessel recanalization at 24 (±6) hours

  at 24 (±6) hours after randomization

Other Outcomes (3)

• Blood levels of albumin and BNP at 24 (±6) hours after randomization

  at 24 (±6) hours after randomization

• Blood levels of albumin and BNP at 7 (±1) days after randomization or at discharge (whichever occurs first)

  at 7 (±1) days after randomization or at discharge (whichever occurs first)

• The along the perivascular space (ALPS) index at 24 (±6) hours after randomization

  at 24 (±6) hours after randomization

Study Arms (2)

Albumin Group

EXPERIMENTAL

Subjects assigned to the albumin treatment group after achieving successful recanalization (eTICI ≥ 2b) confirmed by DSA post-thrombectomy will receive a 20% human albumin solution at a dose of 0.60 g/kg. The solution will be administered as a constant-rate infusion into the proximal internal carotid artery over 20 minutes. Vital signs and potential infusion-related reactions must be closely monitored throughout the procedure.

Drug: Human serum albumin infusion 20%

Control Group

NO INTERVENTION

Subjects in the control group who have achieved successful recanalization (eTICI ≥ 2b) as confirmed by DSA following mechanical thrombectomy will not receive the investigational infusion and will undergo standard medical management only.

Interventions

Human serum albumin infusion 20% DRUG

20% human albumin solution at a dose of 0.60 g/kg will be administered as a constant-rate infusion into the proximal internal carotid artery over 20 minutes.

Albumin Group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years; 2.ICA or MCA-M1 occlusion, confirmed by preoperative CTA/MRA/DSA. ICA occlusion can be cervical or intracranial, with or without tandem MCA lesions; Treated with EVT resulting in recanalization ((expanded Thrombolysis in Cerebral Infarction \[eTICI\] 2b-3); 3.Baseline NIHSS scores ≥ 6; 4.Baseline ASPECTS ≥6 on non-contrast CT; 5.The time from stroke onset/last seen well to arterial puncture is within 24 hours; 6.No significant pre-stroke disability (pre-stroke mRS ≤2); 7.Signed informed consent from the patient or the legally authorized representative

You may not qualify if:

• Presence of intracranial hemorrhage on head CT or MRI； 2.Midline shift with significant mass effect on head CT or MRI； 3.History of heart failure or severe cardiovascular disease, including but not limited to pulmonary hypertension, pericardial effusion, etc； 4.Arrhythmia accompanied by hemodynamic instability； 5.Symptoms or electrocardiographic evidence of acute myocardial infarction upon admission； 6.Acute or chronic renal failure (serum creatinine \>2.0 mg/dL)； 7.Severe anemia (hematocrit \<32%)； 8.Known allergy to albumin or blood products； 9.Pregnant women； 10.Persistent blood pressure ≥180/100 mmHg prior to albumin infusion； 11.Concurrent participation in another clinical trial； 12.Life expectancy of less than 3 months； 13.Coexisting severe pulmonary diseases such as Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, pleural effusion, pulmonary hypertension, or acute respiratory distress syndrome； 14.Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead
• The First Hospital of Qinhuangdao: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ming Wei PhD, PhD

CONTACT

86+13502182903; weiming@tmu.edu.cn

Du, PhD

CONTACT

dkj1024@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: independent Imaging Core Laboratory
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12