CompletedPhase 1

Intra-arterial Albumin Infusion After Endovascular Therapy for Stroke Patients

China57 participantsStarted 2023-08-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 adminis…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All cause of death

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

Trial details

NCT IDNCT05953623

SponsorTianjin Huanhu Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-29

View on ClinicalTrials.gov More Stroke, Acute Ischemic trials