Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Reperfusion Therapy

NCT06538844 | Completed Phase 2

• 1 other identifier: ARISE
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 8

Brief Summary

The objective of this study is to evaluate the effectiveness and safety of endovascular therapy combined with 25% human albumin in the treatment of acute large vessel occlusive stroke.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Changes in infarction volume from Day 5 to baseline.

  From 5 days after surgery to baseline

Secondary Outcomes (19)

• Early neurological improvement within 24 hours

  within 24 hours

• NIHSS score at 24 hours

  at 24 hours

• Proportion of successful reperfusion (mTICI 2b/3)

  immediate postoperative

• NIHSS score at 5 days

  at 5 days

• Proportion of patients with functional independence (mRS 0-1) at 90 days

  at 90 days

Study Arms (2)

Human albumin treatment group

EXPERIMENTAL

Drug: Intravenous infusion of human albumin

Placebo group

PLACEBO COMPARATOR

Drug: Saline

Interventions

Intravenous infusion of human albumin DRUG

Administer 0.5g/kg of 25% human albumin intravenously as soon as possible within 60 minutes after randomization. And administer 0.5g/kg of 25% ALB intravenously every day on the second, third, and fourth days after randomization.

Human albumin treatment group

Saline DRUG

Equivalent volume of isotonic saline control

Placebo group

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 between 18 and 80 years;
• Anterior circulation acute ischemic stroke, with acute occlusion of the responsible vessel located in the intracranial segment of the internal carotid artery, or the M1 or M2 segment of the middle cerebral artery;
• National Institute of Health Stroke Scale (NIHSS) score ≥6;
• Modified Rankin Scale (mRS) score ≤1 before onset of the disease;
• Alberta Stroke Program Early CT Score (ASPECTS) ≥3 points;
• Ischemic-core volume ≤100ml;
• Patient treatable within 24 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline) if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history. Treatment start is defined as groin puncture.;
• Written informed consent provided by the patients or their legal relatives.

You may not qualify if:

• Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan；
• History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;
• Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
• Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
• Pregnancy, breastfeeding；
• An episode or exacerbation of congestive heart failure from any cause in the past 6 months;
• History of heart valve disease complicated by congestive heart failure within the past 6 months；
• Cardiac surgery with thoracotomy (eg coronary artery bypass grafting or valve replacement surgery) within the past 6 months；
• Acute myocardial infarction in the past 6 months;
• Signs or symptoms of acute myocardial infarction upon admission, including electrocardiographic findings；
• Elevated serum troponin concentration upon admission (\>0.1 μg/L) ；
• Acute arrhythmia (including any tachycardia or bradycardia) with hemodynamic instability (systolic blood pressure \<100 mm Hg) upon admission；
• Acute or chronic lung diseases requiring long-term or intermittent oxygen therapy；
• Findings on physical examination of any of the following abnormalities: (1) Jugular venous distension (jugular venous pulsation \>4 cm above the sternal angle); (2) Resting tachycardia due to congestive heart failure (heart rate \> 100 per/min); (3) Third heart sound; (4) Abnormal hepatic jugular venous reflux; (5) Pitting edema of the lower extremities attributable to congestive heart failure or without apparent cause; (6) Rales in both lungs; (7) Or evidence of pulmonary edema, pleural effusion, or pulmonary vascular redistribution on chest X-ray；
• Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 60 mL/min;

Sponsors & Collaborators

• Capital Medical University: lead
• Xuanwu Hospital, Beijing: collaborator

Study Sites (8)

Maanshan People's Hospital

Ma’anshan, Anhui, China

Location

Suzhou Municipal Hospital of Anhui Province

Suzhou, Anhui, China

Location

Luoyang Central Hospital Affiliated to Zhengzhou University

Luoyang, Henan, China

Location

Nanyang Central Hospital

Nanyang, Henan, China

Location

First People's Hospital of Zhengzhou City

Zhengzhou, Henan, China

Location

Xihua County People's Hospital

Zhoukou, Henan, China

Location

Northern Jiangsu People's Hospita!

Yangzhou, Jiangsu, China

Location

Liaocheng Third People's Hospital

Liaocheng, Shandong, China

Location

Related Publications (1)

• Liu Y, Dong X, Chu X, Ma Z, Yi T, Wen C, Liu Y, Sun J, Xu J, Li W, Yang L, Wang B, Shi L, Li J, Zhang X, Li C, Chen W, Li C, Wu D, Hou C, Zhou C, Li M, Xu Y, Wu C, Ji X. Albumin for patients with acute large-vessel occlusive stroke undergoing endovascular therapy (ARISE): the protocol of a randomized double-blind trial. Front Neurol. 2025 Jul 18;16:1570184. doi: 10.3389/fneur.2025.1570184. eCollection 2025.

  PMID: 40757028 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: August 10, 2024
• Primary Completion: December 20, 2024
• Study Completion: March 15, 2025
• Last Updated: April 2, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)