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NCT Number: NCT07294391

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: at 24 (±6) hours after randomization

    MRI-DWI

Secondary outcomes

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

    Time frame: at 90 (±14) day after randomizatio

    mRS

  2. Infarct volume at 24 (±6) hours

    Time frame: at 24 (±6) hours after randomization

    MRI-DWI

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

    Time frame: at 90 (±14) day after randomization

    mRS

  4. mRS score at 90 (±14) days

    Time frame: at 90 (±14) days after randomization

    mRS

  5. Vessel recanalization at 24 (±6) hours

    Time frame: at 24 (±6) hours after randomization

    CTA or MRA or DSA

  6. NIHSS score at 24 (±6) hours

    Time frame: at 24 (±6) hours after randomization

    NIHSS

  7. NIHSS score at 7 (±1) days/at discharge

    Time frame: at 7 (±1) days/at discharge after randomization

    NIHSS

  8. EQ-5D-5L at 90 (±14) days

    Time frame: at 90 (±14) days after randomization

    EQ-5D-5L

  9. Proportion of Barthel Index ≥95 at 90 (±14) days

    Time frame: at 90 (±14) days after randomization

    Barthel Index

  10. Incidence of all-cause death within 90 (±14) days

    Time frame: at 90 (±14) days after randomization

    all-cause death

  11. Incidence of symptomatic intracranial hemorrhage within 24 (±6) hours

    Time frame: at 24 (±6) hours after randomization

    according to the modified Heidelberg Bleeding Classification

  12. Incidence of intracranial hemorrhage within 24 (±6) hours

    Time frame: at 24 (±6) hours after randomization

    all-cause

  13. Incidence of serious adverse events within 90 (±14) days

    Time frame: at 90 (±14) days after randomization

    serious adverse events

  14. Incidence of adverse events within 90 (±14) days

    Time frame: at 90 (±14) days after randomization

    adverse events

  15. Proportion of early neurological deterioration at 24 hours

    Time frame: at 24 hours after randomization

    defined as ≥ 4-point increase in NIHSS score from baseline

  16. Proportion of severe disability at 90 (±14) days

    Time frame: at 90 (±14) days after randomization

    defined as mRS 4-6

  17. Incidence of albumin infusion-associated adverse event within 24 (± 6) hours

    Time frame: at 24 (± 6) hours after randomization

    albumin infusion-associated adverse event

Other outcomes

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

    Time frame: at 24 (±6) hours after randomization

    albumin and BNP

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

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

    albumin and BNP

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

    Time frame: at 24 (±6) hours after randomization

    along the perivascular space index

Study contacts

Contact information is provided by the study sponsor or research team.

Du, PhD

CONTACT

[email protected]

Ming Wei PhD, PhD

CONTACT

[email protected]

86+13502182903

Sponsors and collaborators

Lead sponsor

Tianjin Huanhu Hospital

Other

Collaborators

  • The First Hospital of Qinhuangdao

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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