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

The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke：Dual-Center, Prospective, Open-Label, Endpoint-Blinded, Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke From Large Vessel Occlusion
• Intervention / Treatment: Drug: Human serum albumin infusion 20%

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ming Wei PhD, PhD; Phone Number: 86+13502182903; Email: weiming@tmu.edu.cn
• Study Contact Backup: Name: Du, PhD; Email: dkj1024@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1.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

Exclusion Criteria:

• 1.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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albumin Group; 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%; 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.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth in infarct volume at 24 (±6) hours after randomization compared to baseline	MRI-DWI	at 24 (±6) hours after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of favorable functional outcome at 90 (±14) days, defined as mRS 0-2	mRS	at 90 (±14) day after randomizatio
Infarct volume at 24 (±6) hours	MRI-DWI	at 24 (±6) hours after randomization
Proportion of excellent functional at 90 (±14) days, defined as mRS 0-1	mRS	at 90 (±14) day after randomization
mRS score at 90 (±14) days	mRS	at 90 (±14) days after randomization
Vessel recanalization at 24 (±6) hours	CTA or MRA or DSA	at 24 (±6) hours after randomization
NIHSS score at 24 (±6) hours	NIHSS	at 24 (±6) hours after randomization
NIHSS score at 7 (±1) days/at discharge	NIHSS	at 7 (±1) days/at discharge after randomization
EQ-5D-5L at 90 (±14) days	EQ-5D-5L	at 90 (±14) days after randomization
Proportion of Barthel Index ≥95 at 90 (±14) days	Barthel Index	at 90 (±14) days after randomization
Incidence of all-cause death within 90 (±14) days	all-cause death	at 90 (±14) days after randomization
Incidence of symptomatic intracranial hemorrhage within 24 (±6) hours	according to the modified Heidelberg Bleeding Classification	at 24 (±6) hours after randomization
Incidence of intracranial hemorrhage within 24 (±6) hours	all-cause	at 24 (±6) hours after randomization
Incidence of serious adverse events within 90 (±14) days	serious adverse events	at 90 (±14) days after randomization
Incidence of adverse events within 90 (±14) days	adverse events	at 90 (±14) days after randomization
Proportion of early neurological deterioration at 24 hours	defined as ≥ 4-point increase in NIHSS score from baseline	at 24 hours after randomization
Proportion of severe disability at 90 (±14) days	defined as mRS 4-6	at 90 (±14) days after randomization
Incidence of albumin infusion-associated adverse event within 24 (± 6) hours	albumin infusion-associated adverse event	at 24 (± 6) hours after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood levels of albumin and BNP at 24 (±6) hours after randomization	albumin and BNP	at 24 (±6) hours after randomization
Blood levels of albumin and BNP at 7 (±1) days after randomization or at discharge (whichever occurs first)	albumin and BNP	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	along the perivascular space index	at 24 (±6) hours after randomization

Collaborators and Investigators

• Sponsor: Tianjin Huanhu Hospital
• Collaborators: The First Hospital of Qinhuangdao

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: albumin; neuroprotection; mechanical thrombectomy; Acute ischemic stroke; large vessel occlusion
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: TJHH_WM_20251125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No